, Author at - Page 15 of 45

Ethics in Pharmaceutical Sales :Striking a Balance Between Business and Patient Welfare

Ethics in Pharmaceutical Sales

Ethics in Pharmaceutical Sales, Pharmaceutical sales constitute a pivotal function within the healthcare sector, serving as a critical link between the production of medications and their accessibility to patients. The significance of this role lies in its ability to facilitate the dissemination of essential treatments, ensuring they reach individuals in need. Despite its inherent importance, the pharmaceutical sales domain is not impervious to ethical dilemmas. The pursuit of revenue goals and a competitive advantage by pharmaceutical companies introduces a nuanced dimension to the ethical considerations associated with sales practices.

In the pharmaceutical industry, where profitability and market competitiveness are paramount, the ethical facets of sales strategies often face scrutiny. This essay delves into the intricate landscape of ethics within pharmaceutical sales, seeking to unravel the multifaceted dynamics that govern this field. Emphasizing the delicate equilibrium required between business objectives and the fundamental well-being of patients, it explores the ethical challenges that arise when companies navigate the intricate intersection of commerce and healthcare. The exploration encompasses the ethical dilemmas posed by marketing tactics, pricing strategies, and interactions with healthcare professionals, highlighting the intricate ethical framework that must be navigated to uphold both corporate success and patient welfare.

The Pharmaceutical Sales Environment

In the realm of pharmaceuticals, the process of selling involves the dynamic promotion and distribution of medications to healthcare professionals and institutions. At the forefront of this intricate ecosystem are sales representatives, commonly known as medical or pharmaceutical representatives, who assume a pivotal role in conveying comprehensive information about newly developed drugs. This information includes insights into the drugs’ advantages, as well as guidelines pertaining to their usage.

The pharmaceutical industry is characterized by intense competition, as companies vigorously strive to secure a substantial market share and ensure profitability. The competitive landscape necessitates adept navigation of regulatory frameworks, understanding the nuances of medical science, and cultivating strong relationships with healthcare stakeholders. Sales representatives, acting as the linchpin between pharmaceutical companies and the healthcare community, are tasked with the responsibility of not only promoting products but also staying abreast of scientific advancements and industry trends.

Furthermore, the pharmaceutical sales process involves navigating a complex web of regulations and compliance standards, given the stringent oversight governing the development, manufacturing, and marketing of pharmaceutical products. Sales representatives are required to demonstrate a profound understanding of these regulations to ensure that their promotional activities align with industry guidelines and ethical standards.

In essence, pharmaceutical sales is a multifaceted endeavor that extends beyond the mere exchange of products. It encompasses a strategic interplay of information dissemination, relationship-building, regulatory compliance, and adaptation to the ever-evolving landscape of medical science and market dynamics. Successful engagement in pharmaceutical sales demands a nuanced approach that goes beyond traditional selling tactics, requiring a deep understanding of both the scientific and business facets of the industry.

Key Players in the Pharmaceutical Industry

Company	Market Capitalization (USD)	Revenue (2022, USD)	Key Products
Pfizer Inc.	$250 billion	$85.6 billion	Lipitor, Viagra, Prevnar, Xeljanz
Roche Holding AG	$302 billion	$68.1 billion	Rituxan, Avastin, Herceptin, Tamiflu
Johnson & Johnson	$488 billion	$93.8 billion	Remicade, Imbruvica, Stelara, Zytiga
Novartis International	$229 billion	$53.7 billion	Gilenya, Lucentis, Cosentyx, Diovan
Merck & Co. Inc.	$204 billion	$47.7 billion	Keytruda, Gardasil, Januvia, Propecia

Ethical Challenges in Pharmaceutical Sales

Off-Label Marketing

Ethics in Pharmaceutical Sales, A significant ethical dilemma within the realm of pharmaceutical sales revolves around the issue of off-label marketing. This ethical concern arises when pharmaceutical companies engage in the promotion of a drug for purposes that have not been officially sanctioned by regulatory authorities. Off-label use refers to the prescription of a medication for conditions or patient populations that fall outside the scope of its approved indications.

While healthcare providers are permitted to exercise their discretion and prescribe drugs for off-label purposes based on their clinical judgment and expertise, pharmaceutical companies are obligated to operate within stringent guidelines when it comes to promoting their products. The ethical tension arises from the potential divergence between the legitimate medical needs of patients and the commercial interests of pharmaceutical firms.

The practice of off-label marketing raises several ethical considerations. First and foremost, there is a concern about patient safety and well-being. When drugs are promoted for uses that have not been rigorously evaluated and approved by regulatory bodies, there is an inherent risk of exposing patients to unanticipated side effects or ineffective treatments. This misalignment between commercial interests and patient welfare underscores the ethical imperative for pharmaceutical companies to prioritize accurate and transparent communication about the approved uses of their products.

Furthermore, off-label marketing can erode the trust between healthcare providers and pharmaceutical companies, as it may create a perception that commercial interests are taking precedence over scientific evidence and patient safety. This erosion of trust has broader implications for the healthcare ecosystem, affecting the collaborative efforts between medical professionals and the pharmaceutical industry in advancing healthcare solutions.

To address these ethical concerns, regulatory bodies play a pivotal role in overseeing and enforcing guidelines that govern the promotion of pharmaceutical products. Companies must navigate a delicate balance between promoting their products to healthcare professionals for approved uses and avoiding the temptation to overstep ethical boundaries by encouraging off-label uses without robust scientific support.

In summary, the ethical challenges associated with off-label marketing in pharmaceutical sales revolve around the tension between the legitimate medical needs of patients and the commercial interests of pharmaceutical companies. Striking the right balance requires a commitment to transparency, adherence to regulatory guidelines, and a focus on prioritizing patient welfare over profit motives.

Notable Cases of Off-Label Marketing

Company	Drug	Off-Label Use	Legal Consequences
Pfizer Inc.	Neurontin	Bipolar disorder, migraines, and neuropathic pain	$430 million settlement in 2004
Johnson & Johnson	Risperdal	Dementia in elderly patients	$2.2 billion settlement in 2013
Eli Lilly and Company	Zyprexa	Dementia and mood disorders	$1.42 billion settlement in 2009
AstraZeneca	Seroquel	Aggression, Alzheimer's, PTSD	$520 million settlement in 2010

Incentives and Gifts to Healthcare Professionals

Ethics in Pharmaceutical Sales, Pharmaceutical companies frequently offer incentives, gifts, or sponsorships to healthcare professionals as a means to promote the utilization of their pharmaceutical products. Although these practices may fall within legal boundaries, they give rise to ethical apprehensions regarding their potential impact on the impartiality of medical decision-making.

The relationship between pharmaceutical companies and healthcare professionals is intricate and multifaceted. In an attempt to enhance brand awareness and increase product visibility, pharmaceutical companies may extend various perks to healthcare professionals, including financial incentives, gifts, or financial support for educational events and conferences. While such initiatives are not inherently illegal, they do invite scrutiny due to the potential influence they may exert on healthcare professionals’ prescribing practices.

The concern lies in the potential conflict of interest that may arise when healthcare professionals receive these inducements. The fear is that these incentives could compromise the objectivity of medical decision-making, leading healthcare professionals to prioritize certain drugs over others based on factors beyond their therapeutic efficacy. This scenario poses ethical challenges as it may undermine the fundamental principle of patient-centered care, where treatment decisions should be solely guided by the best interests of the patient.

To address these ethical concerns, there have been ongoing efforts to establish and enforce guidelines and regulations that govern the interactions between pharmaceutical companies and healthcare professionals. These measures aim to promote transparency, limit the extent of financial relationships, and ensure that medical decisions remain grounded in evidence-based practices rather than influenced by external incentives.

In summary, while the practices of providing incentives, gifts, or sponsorships by pharmaceutical companies to healthcare professionals are legally permissible to a certain extent, the ethical implications surrounding these interactions necessitate careful consideration. The ongoing discourse on this issue underscores the importance of maintaining the integrity of medical decision-making to safeguard the trust and well-being of patients.

Examples of Pharmaceutical Company Payments to Healthcare Professionals

Company	Payments (USD)	Purpose of Payments	Notable Cases
Novartis International	$112 million (2019)	Speaker fees, meals, and travel expenses	Settlement in a 2015 lawsuit
Johnson & Johnson	$2.7 million (2021)	Speaker fees and consulting payments	Settlement with the DOJ in 2019
GlaxoSmithKline	$3 billion (2012)	Kickbacks, false claims, and off-label promotion	One of the largest healthcare fraud settlements

Patient Privacy and Data Security

Ethics in Pharmaceutical Sales, The growing adoption of digital technologies in the field of pharmaceutical sales has given rise to apprehensions regarding the safeguarding of patient privacy and ensuring the security of sensitive data. As pharmaceutical companies delve into the realm of digitalization, they find themselves confronted with a complex ethical landscape, particularly concerning the acquisition, retention, and utilization of patient data for marketing endeavors.

In this context, the ethical challenges manifest in various stages of the data lifecycle, commencing with the collection process. Companies need to grapple with questions surrounding the transparency and consent mechanisms employed when gathering patient information. Transparency ensures that patients are adequately informed about the data being collected, the purposes for which it will be used, and any potential implications. Obtaining informed consent becomes pivotal in respecting the autonomy and privacy rights of individuals, as it empowers them to make informed decisions regarding the use of their data.

Moving forward, the storage of patient data demands a robust infrastructure that not only safeguards against unauthorized access but also ensures the integrity and confidentiality of the information. The implementation of stringent security measures becomes imperative to thwart potential breaches that could compromise patient confidentiality. This involves employing encryption protocols, access controls, and regular audits to monitor and fortify the security apparatus.

Moreover, the ethical considerations extend to the subsequent use of patient data for marketing endeavors. Striking a balance between leveraging data to enhance pharmaceutical sales and respecting patient privacy requires a delicate approach. Companies must prioritize responsible data usage, ensuring that marketing strategies are ethically aligned with the expectations and preferences of patients. This involves avoiding intrusive practices, respecting opt-out preferences, and refraining from exploiting sensitive health information for commercial gains.

In essence, the integration of digital technologies in pharmaceutical sales necessitates a conscientious approach by companies, where ethical considerations surrounding patient data take center stage. By implementing transparent data collection practices, fortifying data security measures, and adhering to ethical marketing principles, pharmaceutical companies can navigate the challenges posed by the digital era while upholding the trust and privacy of the individuals they serve.

Data Breaches in Pharmaceutical Companies

Company	Date of Breach	Nature of Breach	Consequences
Pfizer Inc.	2020	Unauthorized access to customer data	Fines and reputational damage
AstraZeneca	2018	Insider breach resulting in data theft	Investigations and enhanced security measures
Merck & Co. Inc.	2017	Petya ransomware attack	Disruption of operations and financial losses

Ethical Frameworks and Solutions

Ethics in Pharmaceutical Sales, Tackling ethical dilemmas within the realm of pharmaceutical sales necessitates the implementation of comprehensive ethical frameworks and the development of solutions that span the entire industry. This involves fostering a collaborative effort among regulatory bodies, healthcare professionals, and pharmaceutical companies to not only define but also rigorously enforce ethical standards.

To delve deeper into this concept, it is crucial to understand that ethical challenges in pharmaceutical sales can encompass a wide range of issues, such as marketing practices, interactions with healthcare providers, drug pricing, and the transparency of clinical trial data. Robust ethical frameworks serve as guiding principles that help navigate these complex issues by providing a set of values and standards that uphold the integrity of the industry.

The involvement of regulatory bodies is instrumental in ensuring that these ethical frameworks are not just aspirational but are also legally binding. These bodies play a key role in formulating and updating regulations that govern pharmaceutical sales, ensuring that they align with evolving ethical considerations and maintain public trust.

Collaboration with healthcare professionals is equally vital, as they are at the frontline of patient care and can provide valuable insights into the impact of pharmaceutical sales practices on patient well-being. Establishing open lines of communication between pharmaceutical companies and healthcare professionals fosters a relationship built on transparency and mutual understanding, reducing the potential for conflicts of interest and unethical behavior.

Moreover, pharmaceutical companies themselves play a pivotal role in driving ethical practices within the industry. This involves not only adhering to established ethical standards but also actively engaging in initiatives that promote transparency, fair pricing, and responsible marketing.

In summary, addressing ethical challenges in pharmaceutical sales is a multifaceted endeavor that requires a concerted effort from regulatory bodies, healthcare professionals, and pharmaceutical companies. The adoption of robust ethical frameworks serves as a foundation for establishing and maintaining industry-wide ethical standards, ensuring the integrity of pharmaceutical sales and, ultimately, safeguarding the well-being of patients.

Compliance with Regulations

Ethics in Pharmaceutical Sales, Pharmaceutical companies are obligated to meticulously comply with the regulatory frameworks established by government agencies, such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). This stringent adherence encompasses a multifaceted commitment to guaranteeing that all promotional endeavors are in strict accordance with the approved uses of their products. Additionally, companies must uphold transparency and legality in their financial relationships with healthcare professionals.

The regulatory landscape governing pharmaceutical activities serves as a safeguard to protect public health and ensure the integrity of the healthcare system. The U.S. FDA and the European Medicines Agency, among other regulatory bodies globally, set forth guidelines and standards that pharmaceutical companies must follow to ensure the safety, efficacy, and quality of their products.

One critical aspect of adherence to regulations involves promotional practices. Pharmaceutical companies must ensure that their promotional materials, whether aimed at healthcare professionals or the general public, accurately reflect the approved uses and indications of their drugs. This helps prevent misinformation and ensures that healthcare providers and consumers have reliable and truthful information about the products.

Furthermore, the financial relationships between pharmaceutical companies and healthcare professionals must be characterized by transparency and legality. This is to avoid conflicts of interest and any potential influence that may compromise the objectivity of healthcare professionals in their clinical decision-making processes. Disclosing financial ties and maintaining ethical interactions with healthcare professionals contribute to the overall credibility and trustworthiness of the pharmaceutical industry.

In summary, the strict adherence to regulations established by government agencies is integral to the pharmaceutical industry’s ethical conduct. By aligning promotional activities with approved uses and maintaining transparent and lawful financial relationships, pharmaceutical companies contribute to building a foundation of trust, ensuring patient safety, and upholding the integrity of the healthcare system.

Training and Education

Ethics in Pharmaceutical Sales, Sales representatives must receive thorough training in ethical guidelines and compliance standards to ensure a deep understanding of the principles governing their conduct. This training is crucial for instilling a strong awareness of the significance of promoting pharmaceutical products based on rigorous scientific evidence and within the confines of regulatory approvals.

The comprehensive training program should cover various aspects, including but not limited to, ethical considerations, legal obligations, and industry-specific guidelines. Sales representatives need to be well-versed in the ethical principles that govern their interactions with healthcare professionals, ensuring that their promotional activities prioritize transparency, honesty, and integrity.

Furthermore, the training should underscore the importance of aligning promotional efforts with scientifically substantiated information. Sales representatives should be equipped with the knowledge and skills to communicate effectively with healthcare professionals, providing accurate and reliable information about the products they promote. Emphasizing the reliance on scientific evidence helps ensure that marketing practices are grounded in the latest research and contribute to the overall credibility of the pharmaceutical industry.

Within the context of regulatory approvals, the training should delve into the specific regulations governing the promotion of pharmaceutical products. This includes understanding the limitations and requirements imposed by regulatory bodies to prevent misinformation, off-label promotion, or other practices that may compromise patient safety.

In summary, the comprehensive training for sales representatives should go beyond a cursory understanding of ethical guidelines and compliance standards. It should delve deep into ethical considerations, legal obligations, and industry-specific regulations, emphasizing the importance of promoting pharmaceutical products based on robust scientific evidence and within the boundaries of regulatory approvals. This approach ensures that sales representatives are well-equipped to navigate the complex landscape of the pharmaceutical industry while upholding the highest standards of professionalism and ethical conduct.

Transparency in Financial Relationships

Pharmaceutical companies ought to openly divulge any financial affiliations they maintain with healthcare professionals and institutions. This commitment to transparency plays a pivotal role in fostering trust among stakeholders, including patients, healthcare providers, and the public. By providing a comprehensive account of financial interactions, pharmaceutical companies contribute to the integrity of medical decision-making processes. This transparency is especially crucial in mitigating concerns about potential conflicts of interest that may arise from financial incentives, safeguarding the integrity of healthcare practices, and upholding the ethical standards of the medical profession. In essence, the transparent reporting of financial relationships is an essential element in building a healthcare ecosystem founded on trust, ethical conduct, and the prioritization of patient well-being over undue financial influences.

Enhanced Data Security Measures

In order to effectively mitigate apprehensions associated with patient privacy and data security, pharmaceutical companies should allocate resources towards the implementation of comprehensive cybersecurity measures. These measures encompass various strategies such as encryption, which involves converting sensitive data into a secure code to prevent unauthorized access. Additionally, adopting secure storage practices is imperative, ensuring that patient information is stored in a manner that safeguards it from potential breaches.

Regular audits play a crucial role in this context, serving as proactive measures to identify and rectify any potential vulnerabilities within the cybersecurity framework. These audits involve systematic examinations of the entire information security infrastructure, scrutinizing the effectiveness of implemented measures and pinpointing areas that may require reinforcement or improvement.

By investing in robust cybersecurity measures, pharmaceutical companies not only demonstrate their commitment to safeguarding patient information but also adhere to industry standards and regulatory requirements. This proactive approach not only protects sensitive data but also fosters trust among patients, healthcare professionals, and regulatory bodies. In an era where digital advancements are integral to healthcare, a strong cybersecurity foundation becomes paramount in maintaining the integrity and confidentiality of patient data.

Final Verdict

Ethics in Pharmaceutical Sales, The ethical considerations within the realm of pharmaceutical sales constitute a complex and multifaceted issue, demanding sustained vigilance and proactive initiatives from all involved parties. It is imperative to achieve a delicate equilibrium between the pursuit of business objectives and the paramount concern for patient well-being. This equilibrium is not only critical for the enduring success of the pharmaceutical industry but, more significantly, for the health and welfare of individuals who depend on these medicinal products.

Maintaining ethical standards in pharmaceutical sales necessitates a commitment to robust frameworks that govern behavior, embracing transparency in all transactions, and proactively investing in education and technological advancements. This multifaceted approach serves as a strategic guide for the pharmaceutical sector to effectively navigate the intricate challenges it faces while fulfilling its overarching responsibility to society.

The first component involves the establishment and adherence to ethical frameworks, which serve as guiding principles for the conduct of individuals and organizations within the pharmaceutical sales domain. These frameworks delineate acceptable practices, ensuring that all stakeholders operate within morally sound parameters.

Transparency stands as another crucial pillar in ethical pharmaceutical sales. This entails openly disclosing information regarding product efficacy, potential side effects, pricing structures, and any conflicts of interest. By fostering transparency, the industry can build trust among stakeholders, including healthcare professionals, regulatory bodies, and most importantly, patients.

Moreover, investing in education is pivotal for cultivating a culture of ethical awareness within the pharmaceutical sector. This involves continuous training programs for sales representatives, healthcare professionals, and other industry personnel to enhance their understanding of ethical considerations, regulatory compliance, and the societal impact of their work.

Technology plays a transformative role in bolstering ethical practices within pharmaceutical sales. Implementing advanced systems for tracking and monitoring transactions, ensuring data security, and leveraging artificial intelligence for compliance checks are examples of how technology can be harnessed to mitigate ethical risks.

By embracing these multifaceted measures, the pharmaceutical sector not only safeguards its own sustainability but also fulfills its ethical obligation to society. This commitment to ethics not only enhances the industry’s reputation but also contributes to the overarching goal of providing safe and effective medications for the betterment of global health.

Ethics in Pharmaceutical Sales :Striking a Balance Between Business and Patient Welfare Read More »

FDA Form 483 and Warning Letter, How do differ from each other?

Self-Inspections

FDA Form 483 and Warning Letters:

It is very important to know how the Warning Letter and FDA Form 483 are issued by the Food and Drug Administration (FDA) after an inspection of a particular drug manufacturing site.

FDA Form 483 and Warning Letters are often confusing for many pharmaceutical professionals, who cannot properly differentiate between the two. Both communications are issued by the Food and Drug Administration (FDA), usually after a regulatory inspection and never before a regulatory inspection.

FDA Form 483:

Form 483 lists observations in order of importance that FDA inspectors record during manufacturing site inspections. Each observation noted on the FDA Form 483 is clear, specific and significant and FDA investigators are specially trained in the matter.

FDA officials communicate their inspection observations on Form 483, and it is usually issued to the manufacturing site after the FDA audit is completed. Observations are not generally made until the investigator’s judgment, conditions or practices observed that any food/drug/device/cosmetic has been adulterated/changed intentionally to its standard practice.

After completion of the Inspection, FDA Form 483s, are discussed with a company’s senior management, regarding the observations of the inspections. To get a full understanding each observation is read and discussed with the company’s senior management so that they get the actual situation regarding inspection observations.

An FDA Form 483, is a report, it does not contain any observations of questionable, or unfamiliar significance at the time of the inspection of a specific firm. It only reports on familiar objectionable conditions. which are observed during the inspection. even if it can’t report other objectionable conditions which didn’t notice during the inspection. The company/Firm is only responsible. to correct the objectionable conditions which are noticed after the completion of the inspection on the due date.

How to handle FDA Form 483?

Upon completion of the FDA inspector’s manufacturing site inspection, the manufacturing site authority should discuss all findings with the FDA inspector and make every effort to resolve negative observations before the inspector leaves the site.

If errors and miscommunications occur, it is best to consult with inspectors.

Try to understand the positive or negative mood of the regulatory body; Their mood can be negative for various reasons or for no reason at all.
Without any hesitation ask any questions to the inspector regarding confusion found during observations.

If you think, you can convince the inspector. Try to convince the inspector/inspectors regarding observations found during inspection with the help of related information. Your convincing power may help to delete some observations from FDA 483.

The purpose of an FDA Form is to notify the company’s senior management regarding objectionable conditions. The FDA Form 483 is presented and discussed with the company’s senior management after the completion of the inspection. Senior management of the Companies is encouraged to respond to the FDA Form 483 with a corrective action plan within the due date.

See Practical Example of

Form 483:

Form 483 for Stryker Craniomaxillofacial Division. Portago, MI.

Form 483 for Teva Parenteral Medicines, Inc. Irvine, CA. Form 483.

Form 483 for Cipla Limited Compliance Record.

Form 483 for Ranbaxy Laboratories Limited.

Form 483 for Lupin Limited.

Warning Letter

Warning Letter for Cipla Limited.

Warning Letter for BioMD Plus LLC.

Warning letter for Walmart inc.

Warning letter for Elements brands inc.

Warning Letter for Alber GmbH.

It is mandatory to respond to the FDA Form 483 within 15 days otherwise regulatory agency will not consider your response regarding the final observation of your company.

FDA Form 483 is not the final decision maker. It just considers along with a written report known as Establishment Inspection Report. All evidence or documentation collected from the manufacturing site, response made by the company/firm. The agency considers all of the information and then they made the final decision for further action.

You may avoid the issuance of a Warning Letter if you respond to FDA Form 483 within due time with appropriate justification.

Form FDA 483 content

Header information

It contains the following information:
[] FDA district office Address and phone number
[] Date(s) of inspection
[] Facility’s FEI [FDA Establishment Identification number].
[] Name and title of the individual to whom the 483 is issued
[] Address of the facility that was inspected and
[] Brief description of the type of facility

Observations

This section presents all the listed observations made by FDA investigators [Number of Investigators may be one to three persons or as per FDA policy]. This section contains all of the inspectional observations and this is not the final agency decision. You can consult with the FDA investigator regarding the observations and also can share your plan and implementation regarding observations. If you have any questions you can contact with FDA with the header section and contact number.

Annotation

During the final discussion, the actual annotation of the 483 occurs with the firm’s management. If the firm management prefers no annotation, then it will not happen. Annotations may be placed at the end of each page or at the last page of the observations where the investigators generally put their signatures. In 1997 FDA introduces an annotation policy for medical device inspections.

Signatures

For multiple pages, the FDA investigator’s signatures have on the first page and the last page only other pages only initialed. All investigators’ names are printed and signed, & issue date is recorded in this section. FDA investigator’s title may be included there.

Reverse side

This side contains some instructional text regarding Food, Safety, and device cosmetics. And also contains some instructions regarding FDA investigators to their nature of work in the inspected site. All the instructions mention these sections are backed by their specific reference such as

-Pursuant to Section 704(b) of the Federal Food, Drug, and Cosmetic Act
-Section 704(b) of the Federal Food, Drug, and Cosmetic Act

Warning Letter:

The next step after issuing FDA Form 483 is Warning Letter. FDA may issue a Warning Letter to the manufacturing site which has already been visited and inspected by FDA Inspector. Serious violations of the quality of the product may lead to the issuance of a Warning Letter. Generally, Warning Letter is issued by the higher officials of the FDA after the review of the inspection observations and especially reviewing the product quality matters.

After the issuance of FDA Form 483 and completion of the inspection, a regulatory agency may issue a Warning Letter to the manufacturing site. When any serious issue is found regarding the quality of the product, a Warning Letter is issued by the higher officials of the FDA after the review of the inspection observations. It contains evidence and detailed explanations for the observations. FDA high officials generally concentrate on the quality of the product and do not compromise with it.

A Warning Letter should be replied to within the given time because a delay can lead to an import ban. It may be asked for an extension of the time to justify the things. Most of the Warning Letter issued by FDA high officials has the quality or cGMP issues of the product or facility.

You may easily find both FDA Form 483 and Warning Letters on their website due to these are published immediately publically on fda.gov. and anyone can get it.

Type of warning letter

General FDA Warning Letters
Tobacco Retail Warning Letters
Drug Marketing and Advertising Warning Letters

General FDA Warning Letters

This type of warning letter is issued when FDA found that the manufacturer has significantly violated FDA regulations. Poor manufacturing practices, problems with claims for what a product can do, or incorrect directions for use lead to the issuance of General FDA Warning Letters. The problem mentioned in the warning letter must correct by the company and the action plan to be shared with FDA and subsequent interaction may change the status of the issues mentioned in the letter.

Tobacco Retail Warning Letters

tobacco retailers occur periodically face Compliance check inspections under the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) and the Regulations Restricting the Sale and Distribution of Smokeless Tobacco and Cigarettes to Protect Children and Adolescents. Cigarettes and smokeless tobacco also include in compliance check inspections.

Drug Marketing and Advertising Warning Letters

Letters are collected and sorted by month and only cover drug marketing activities. Some of the letters may be edited to remove confidential information. Letters sent electronically may be engaged in illegal activities.

Close-Out of Warning Letter

Warning Letter “close-out letter” issued by FDA. Once the agency completed the evaluation of corrective actions taken by the manufacturing site in response to the Warning Letter and the agency found the corrective action satisfactory then the agency may issue a close-out letter. A ‘close-out letter’ will not be issued depending on some action taken by the firm. The corrective action must be verified by FDA. The agency expects that corrections have been implemented and verified by follow-up inspection.

If any violations exist that can’t be corrected then no “close-out letter” will issue. Future FDA inspection may further assess the violations and enforcement action may be taken without prior notice.

FDA Form 483 and Warning Letter, How do differ from each other? Read More »

user requirement specification of Equipment

Documentation, Engineering, Product Development, Production

User Requirement Specification is a specific document where end user generally defines needs, target, goal and their expectation for a system, service and product. This is actually blueprint for the development personnel and it help to ensure that the product meet the target for the specific group.

A standard User Requirement Specification includes information about the user group, targeted use of the product, functional requirements, Operational requirements, and performance requirements. It also contains constraints or limitations.

A standard User Requirement establishes a better understanding between the stakeholders regarding a defined outcome; also sets a specific goal for the end-user and helps to save the project, and product delivery time the best thing is its budget-friendly; the user can previously estimate the cost of the specific project.

URS is generally developed by the buyer defining all listed requirements. After the development of a URS, the user sent it to the equipment manufacturer to prepare it as per predefined criteria.

A poorly developed URS is always creating confusion for the manufacturer, you can see the poorly written URS at the manufacturer’s end and If you don’t know how to write URS then you can ask standard URS template from the manufacturer, they are happy to help you. If supplied Template is found near your requirements then you can go with a modified version.

User Requirement Specification when disregarded?

A confusing URS is always disregarded. If the manufacturer can’t read you then the faulty or wrong machine can be developed which can destroy your project and A meaningful and well-written user requirement specification saves time and money; also reduce misunderstanding among the manufacturer.

A series of emails may generate to explain your requirement to the manufacturer which may express your poor level of understanding of the specific requirement also create of the high chance of wrong specification delivery and You have to express the requirement what exactly you are looking for in your User Requirement Specification (URS).

Keep it simple, Specific, and Better user requirement specification creates better outcomes.

Requirements of user and support design, qualification activities, operations, commissioning, and maintenance are mainly present on the URS. It’s good to set your mind at the start of your dream project.

According to Mark R. Smith, MD, Realtech,

“A standard URS shall be clear, jargon-free, easily readable, not hard to understand which helps to software engineer and Designer clearly readable and understandable of the user requirement with minimum cost and maximum output”.

Types of Requirements

There are several types of requirements that are depicted here.
[] Business Requirements
[] Functional Requirements
[] Stakeholder Requirements
[] Non-Functional Requirements
[] Transition Requirements

What thing to consider for user requirement specification (URS)?
Two main things shall be considered during the writing of URS, number one: What shall be included and number two what shall not be included.

What to include:

During the writing of the URS, the actual information shall be included in the URS. More information may require for big projects and less for a small project the basic of all URS shall be specific. Unknowingly including a feature that is not available in the market is the same as knowingly ruining your project.

Knowing then any feature should be included in the URS. The most important thing is to include only those specifications that are necessary. Features that will never be used need not be included but the facility to use updated features can be retained.

What not to include:

Ambiguous words or terms, Features that are not easy to understand, and that no one has yet used, features that are not user-friendly and will never be used, and features that are overpriced but less important shall be avoided.

How to proceed with your User Requirement Specification?

Before proceeding with your URS, define the responsibility of the stakeholders in your URS then collect all stakeholders’ signatures with designation and date. An approved URS shall be procced to the manufacturer to avoid any wanted circumstances. To sign a document means that you are responsible for it.

What should be included in the Introduction section?

In this section, you should describe more briefly about yourself and why this URS has been raised. Give a short description of your organization. Like “We are Startech is a startup organization in west Virginia. We want to install a high tech tablet compression machine to produce almost 6000K tablets per hour. This user requirement specification (URS) documents the user requirements for producing tablet dosage forms in a tablet compression machine.

The objective of the User Requirement Specification

They clearly describe the goal of the project so that anyone understands it. A brief overview of the project shall be included. Mention the actual purpose of the URS.

Who will write the User Requirement Specification?

Anyone can write URS, who has a thorough knowledge of the system, service, product, or machine in question. But you don’t let someone write something they don’t know about, for example, production personnel can’t write the URS of quality control equipment and vice versa.

How to document a User Requirement Specification?

The user will prepare the URS and another SEM will check the URS and Engineering personnel and the head of the user department will Review the document, finally Head of Quality will approve the URS. Always documented hierarchy shall be maintained.

To write user requirement specifications for a pharmaceutical company equipment following points should be included

1. Front Page: URS no., Revision no., Addendum no., Using Facility shall be mentioned.
2. List of revisions: Revision number shall be mentioned (if required).
3. List of addendums: Addendum to be mentioned (if required).
4. Table of Contents: Write the list content of the URS.
5. List of abbreviations: All abbreviations shall be mentioned.
6. Signature page: Signatory page contains all signatures including Approval authority.
7. Scope: The scope of the URS is to define the specific Equipment/Instrument.

8.0 Procedural Document Requirements:

This part gives information about the Equipment / Instrument including the Purpose of the Equipment, Specification, Qualification, etc.
8.1 Name of the Equipment: Name of the equipment to be mentioned here, if possible, and Model No. to be defined here.
8.2 Purpose of the Equipment: Purpose of the Equipment shall be clearly defined here.
8.3 Number of Equipment Required: Require quantity of the Equipment/Instrument shall be defined here.
8.4 Qualification: A list of qualification documents shall be mentioned here.
8.5 Specification of Equipment: All major specifications of the Equipment/Instrument shall be mentioned here.

9.0 Operational Requirements:

9.1 Vendor Scope: The Vendors scope shall include the Supply, Installation, and Documentation including calibration certificates, User training, and Details of service/maintenance contracts available.
9.2 Operation: Basic operative characteristics including Data logging (21 CFR part 11), controlling system, capacity, safety, and protection, the capacity of basic function, etc.
9.3 Options and Ancillaries: The vendor should identify, where applicable, their standard equipment that fits this specification. The vendor shall (where possible) also provide costs including, A range of additional maintenance support and services., Any additional accessories to fulfill the requirements indicated in section 9.2.
9.4 Interfaces: A user-friendly control system is required, that can allow system operation with a minimal amount of training.
9.5 Data and Security: If required, data and security articles are to be clearly defined here.
9.6 Environment: Instruments/Equipment’s operating environment should be clearly defined here. The operating area must fit with the specific Instruments/Equipment in such a way that it can be operated without any difficulty.

10.0 Constraints

10.1 Milestones and Timelines: A projected timeline and milestone may be set here.
10.2 Compatibility and Support: The internal components of the system must be compatible with, and resistant to, the materials used during operation. Operating power to be mentioned here.
10.3 Maintenance Requirements: The manufacturer should supply details of any maintenance/breakdown packages available.
10.4 Procedural Constraints

11.0 Life Cycle

11.1 Development Procedures: Future development procedures are to be mentioned here.
11.2 Testing Requirements: See Section 11 for a detailed matrix of the validation testing requirements.
11.3 Delivery Requirements: On supply, the following documentation should be supplied: Operation and maintenance manual (including manufacturer’s recommendations for maintenance schedules). Calibration certificates. Parts list and spare requirements. System specifications.
11.4 Support: The vendor must supply details of all service and maintenance requirements of the equipment. The vendor must also supply details of any service and maintenance support that they can supply.

12.0 GMP Requirement: A list of cGMP requirements shall be mentioned here.
13.0 Utilities Available at The Site of Installation: Utilities shall be described here including the power supply for the machine/equipment.
14.0 Documentation Requirement: A list of documents shall be described here such as Operation, cleaning, and maintenance manuals for equipment as well as the operation, Installation instructions/ guideline, other drawings (such as Mechanical, electrical, instrumentation, etc.), IQ/OQ documents & operating manual., Instrument calibration / Qualification certificates traceable to the national reference standards, Guaranty/ warranty certificates for the equipment, Shipping checklist, and Hardware design specification.
15.0 Terms and Conditions to Be Included in The Quotation: All the terms and conditions shall be described here.
16.0 All the discussion shall be noted here and contact personnel details shall be mentioned at the end of the discussion details.
17.0 Annexures: Mention annexures if there are any.
18.0 Validation Requirements:
The following details the test requirements for documentation, testing, and the stage of the project at which they must be provided/performed. These requirements are a minimum tariff, and the vendor is required to include any documentation, not already requested here, which is considered necessary to support the successful validation of the system.

Which things to follow to write a Modern User Requirement Specification?

From the discussion till now we know what to add to our URS and what not to add. Ambiguity to be avoided as much as possible should be written clearly so that anyone who reads it can understand it. Ambiguity is the enemy of any project’s success and expressing yourself as accurately as possible is possible. Communication must be done in an unambiguous manner to achieve good results; Your project will be successful when you are able to convey your message to others.

To write a best User Requirement Specification you need to keep the following points in mind:

1. Focus on Single Requirement:

Check each requirement to be developed and how it is tested. Project success depends on each effective requirement which is really a demand to the project. Avoid unnecessary requirements which really not essential to the project.

2. Avoid Haziness

Your URS must be clearly written. Use a Simple Sentence. No confusing word. Just say what you want and what not.

A user requirement specification should be clearly written, using simple sentences, and without ambiguity. Examples of ambiguous words are:

[] Easy
[] Strong
[] Improve
[] Fast
[] Slow
[] Enough
[] User friendly

What exactly are you meaning “Fast”? this term is theoretical; you can’t actually express your requirement using the word “Fast”. It is hard to measure. Avoid any abbreviations, acronyms, and jargon words (words and phrases, that are not generally understood).

3. Go with the SMART Approach

[] S for Specific
[] M for Measurable
[] A for Achievable
[] R for Realistic
[] T for Time-bound

SMART [Specific, Measurable, Achievable, Realistic, Time-bound) targets offer a decent way to confirm your URS is well-defined and supportable.
Specific: All requirements mentioned in the URS must be specific, clear, and jargon-word-free. Don’t add any unnecessary requirements like easy and fast. Mention the actual specification.

Measurable: Reequipment must be measurable, don’t state anything which can’t confirm by testing or examination. Always avoid theoretical statements like rapid and swift. It can’t measure, you can’t prove that your requirements just met the specification until it is measurable.

Achievable: Never set a requirement which is can’t achieve with help of current technology. A feasibility study shall be done before setting any requirements. You can’t set any requirement which is technically impossible to achieve. It is wise to study well before adding features that you have no idea about. If even then you cannot be confirmed, then seek an expert for help. It is not right to add any feature without knowing it.

Realistic: It’s important to be realistic when determining the list of requirements. Sometimes technically achievable requirements may not be realistic due to regulatory requirements, time restrictions, Budget constraints, or other limitations.

Time-bound: A specific time frame shall be fixed to obtain your project. Even after finishing everything and if the specified time is not fixed, then any project may fail.

4. Organize

Organize your word choice and think carefully about it. Generally, the word “Shall” and “will” define the actual requirement which must be met. Word like “May” and “Could” use to define goals than are expected but not necessarily requirements. So, when you want the requirement must be met then use shall/will and use may/could for not mandatory cases.

5. Control Changes to the Requirements

Any type of changes may require during creating your list of requirements. Changes to the specification of the specific requirement shall be controlled. If any type of change directly affects the requirement, then the requirement shall be updated and a new version shall be created.

6. Requirements Must be Testable

Requirements shall be written in a such way that they can be tested and Specific requirements shall be traceable through the life cycle of the system/service/equipment/instruments.

7. Structural Products

Two types of products may be used as structural products & custom applications; for custom applications, the manufacturer must describe every process step to the user. For structural products, the process steps must be aligned with their predefined specification.

8. Vendor Audit

Most of the cases Regulated companies are most aware of their vendor for periodic assessment. All types of assessment/re-assessment perform in accordance with the Quality Management System (QMS).

9. Specifications

It is essential for the supplier to thoroughly document both the functionality and design of the system which is a prerequisite to ensure successful product development. Documentation must cover all aspects of the system, including software, hardware, and configuration, to meet all requirements to be established.

10. Training & Documentation

The supplier must agree to provide comprehensive system management documentation and provide instructions for both maintenance and use by the supplier and related issues must be agreed upon prior to system purchase.

11. Eliminate Requirement Redundancy

Avoid overcomplicating the system requirements and there is no need to bulk it up by duplicating it. Avoid duplication. Duplicating your documents may require more testing, documentation, and review time, making the project and time progressively longer Don’t include anything which is related to money or finance.

What is the difference between data and information

12. Embrace the Opportunity to Evaluate Vendors

Conducting audits on suppliers may include asking the following questions:
[] Security
[] Product support
[] End User training
[] Company Overview
[] Use of sub-contractors
[] Service delivery process
[] QMS application at the company
[] Development product life cycle
[] Key products development plans
[] Organization, roles, responsibilities, & training

13. Don’t be intimidated by your vendor comparisons

Utilize your URS to evaluate different vendors & note their advantages and disadvantages. If new information is found during the initial stage, feel free to revise your approved URS accordingly through the change control process. It is acceptable to make modifications or adjustments to the requirements to fit your needs until the final approval of the URS and it shall be revised the approved User Requirement Specification accordingly maintaining proper documentation.

14. What ought to be included in the URS?

The contents of a URS naturally include the following (but are not limited):
[] Functional requirements
[] Operational requirements
[] Technical requirements
[] Interface requirements
[] Data requirements
[] Security requirements
[] Regulatory requirements
[] Maintenance requirements
[] Availability requirements
[] Migration of any electronic data
[] Environmental requirements
[] Constraints to be observed
[] Life cycle requirements

15. Categorize Your Requirements

Categorize Your Requirements as-
[] Mandatory (High)
[] Beneficial (Medium)
[] Good to have it (Low)

16. Subjective Knowledge and Processing Step

To ensure that requirements, your professional knowledge is essential but not mandatory; if require you can seek help from an SME [Subject Matter Expert]. To identify key requirements of the system Process knowledge is required which are related to the manufacturing/servicing process. Look for the following key points-
[] Experience
[] Knowledge
[] Documentation

17. The requirements may be incomplete or not fully specified

Sometimes the requirements are not fully understood at the beginning of the project; Requirements evolve over time. URS shall be developed as per requirements when information is available. Don’t share incomplete User Requirement Specifications to the manufacturer to avoid any unwanted requirements.

Frequently Asked Questions

Are URS always required for validation?

At the initial stage of system/service/equipment/instruments, then URS is a valuable tool for ensuring the asking requirements. When an existing system is being validated then URS consider as a functional requirement. These two documents can’t be considered as single documents.

What is the benefit of good User Requirement Specification?

Requirements gathering is an important part of a good software/hardware/service/product development project. Good estimation, improved customer satisfaction, reduced cost, and project duration can all fail if good requirements are not selected and sufficient knowledge is not introduced in the selection If you are unclear about what you are delivering, no one can expect anything better from you.

There are Five main questions that shall be asked to develop any project:
[] Why we are doing it?
[] What do we need to do it?
[] What is the benefit?
[] How do we do it?
[] What is the timeframe?

If we fail to estimate project requirements or are unable to assume what is the requirement, can lead to a poor outcome of the project, and also lead to extra manpower, longer duration, and project costing.

Download Your

User Requirement Specification (URS) Template

user requirement specification of Equipment Read More »

What is the difference between Mass and Weight?

FAQ, Viva

What is the difference between Mass and Weight? Generally, people, treat them same term in practical life but in physics, they are very much different. One is in practical matter another is variable place to place, Hight to Hight depends gravity. What is gravity? force that exists among all material objects in universe. Express as g & it change place to place, Hight to Hight but one thing that is not change, this is it. It is Mass.

If you in Australia your mass is 59kg, if you in UK you are in 59kg if you in USA you are in almost 59kg, if you in Mars, obviously you are in 59kg. It can’t be change. This is just like your personality which never change other is your attitude which always chance place to place.

So, what is the definition of Mass?

Thousands of types of definition you will find in web but I like the following-

Mass can be defined as amount of matter present in you. No matter at what place you are may be in Africa or Europe its value remains constant.

What is the definition of Weight?

Weight is the force by which you are being attracted by this amazing planet. This is very much changeable from planet to planet & height to height. Gravity on Mars is 38 percent of Earth’s gravity, so a 100kg person on Earth would weight 38kg on Mars.

On the other hand, we can say that Mass is actually a physical quantity which measures amount of matter in a body whereas weight is actually the force with which earth pulls our body towards its own center.

How can we express them?

Generally, Mass is express by “m” and its S.I. unit is kg where as Weight is Expressed by “W” and its SI unit is N[Newton].

Weight is mainly the amount of forces force exerted by earth on a mass of any substance. Weight can be calculated as Weight=Mass x g, where g is acceleration due to gravity and its value is 9.8.

Let me explain,

If want to something buys from supermarket or any place where you prefer, may be online, they will mention mass of the Object not weight in practical though some of the company mention weight of the object but actually that it the mass of the object not weight of the object.

You will only get the weight of the object, when you multiply the value with “g”. So, if your weighing machine gives the reading for a object as 100kg then it weight will be 100×9.8=980N. Hope you got it.

Value of the weight is negligibly change in the earth surface as the value of the “g” is not significantly change on our planet surface but a little amount change in poles of the earth as the value of “g” slightly increase inversely in equator area the value decrease.

Evaluation of Mass & Weight

From the very beginning, people are involving their goods for trading. 2-pan balance scale and some reference weights were the primary transaction method to determine the quantity of item. Balance was achieved by placing unknown amount of goods to one pan and another pan contains reference weight. The main problem of the two pan scale was it can’t measure the force only measure the mass.

At the time of the advent of English, the traders referred their known item to compare to the another unknown item as “weights”, and this process known as weighing and thus the result ,mentions as weights at a little before 1000AD.

In late 1600, famous laws of motion developed by Isaac Newton’s but this is not quite accurate in extremely high speeds where theory of special relativity [Albert Einstein’s at 20th-century] is required. Mass depends on how much matter-atoms is an object.

Lot of research on relationship between the quantity of matter & effect of force on that matter, especially with the concept of gravity was performed by Newton & Hooke at 1600s. After the completion of the research, they publish their research paper in Latin as that time it was major communication medium in scientific research.

At 1700s, the Newton and Hooke works start to publish in English and in this process the decided the take the word “Weight” as amount of material which is already use for the centuries and its related to gravity and taking the word “Mass” [ which was unrelated meaning in that time] and having it mean to the amount of material [Similar meaning of Weight as that was using in that time]. So, the great confusion starts then. This was the fault of physicists & their translators.

Mass can be defined as the measurement of an object’s tendency to resist changing its own state of motion, well known as inertia. Left a football on a field will stay put or move in a straight line unless some force like friction, touch by foot or hand or creating obstacle to the line, it will keep moving forward. So much is the measure of force which will require to change its path.

Weight, can be defined as the measure of amount of downwards force that gravity exerts on a specific object. If the mass of the object increases then force increases, the more inertia it contains, then harder gravity pulls. On our Earth’s surface, force of gravity is almost 9.8 newtons per kg.

As the two term was confusing so people involve in trade, law, commerce had no interest to change the long use term “Weight” and continue it. Weight to them, physicists started calling mass already and this practice continue still today.

People who are involving in commerce & Law use the word “Weight” to define the amount of material where never involve the meaning of force and never implement the word “Mass”. At the year of 1750, spring scale was invented and it calibrated to read out the mass which surprisingly works very fine until it moved to significantly different strength of gravity. In our planet, the change of gravity is almost same until it Moves to poles or equator, if do so then change of gravity is not significant. So the traders continue to use the word “Weight” as they are using this term for a long period of time to define the word “Mass”.

At the period of time, physicists start proclaiming that the effectiveness of the Word “Weight” and “Mass” is correct and anyone who used them otherwise is very much incorrect and such shall be obsolete. This is totally insane as the physicists were violating the long-term usage of word “Weight”. They also emphasize the usage of word “Weight” referring forces. But this didn’t reflect the practical life. In practical life, in Commerce and Law, it is very much considered that the Weight is the synonyms of Massa and its correct is kilograms not newtons.

In this context, this is very much meaningful that “I weigh 99 kg” or “My weight is 99 kg” but as per Physics weight is the result of Mass and associated with gravity on its which unit is Newton not kilogram. As discussed, it can’t say forcefully that they are using the terminology incorrectly, moreover in some context the answer of the question is “There is no difference between “Weight and Mass” due to they are synonyms to each other and measured in kilogram.

But there is a clear distinction between the two terminologies where Mass is the amount of material which measured in kilogram and Weight is type of force with Mass measured in Newton. In technical field all of the measurements are associated with the Organization titled as “Weights and Measures”.

As per Scientists “Weight is measured in Newton[N] which is 9.8 times larger than Mass[m] in earth surface and this may vary from place to place [Earth to Moon, Earth to Mars, Earth to Saturn etc.] 10kg of Mass has Weight of 98N and this has the Weight in Moon has 10.6N in Moon.

To simply understand the difference between Weight & Mass is” Mass is the Personality of Matter and Weight is its own attitude which is variable to place to place”.

Mass is actually the intrinsic property of matter which is just like the like personality is of a man and weight is the gravitational pull on the specific object which depends on the other body which is employing on it which is similar to attitude depends on another party.

Expression of Weight and Mass
As per Physical Science, the Mass and Weight are the totally different and their expression is “m” for Mass and unit is kg where Weight express as m x g [g, acceleration due to gravity] and its unit is Newton.

Let consider Mass is m, then
Weight= m[Mass] x g[acceleration due to gravity]

What Is the Difference Between Weight and Mass?

In ordinary conversation, “mass” and “weight” are used interchangeably but they are very much different to each other. Mass is defined as the amount of material present in the matter where Weight is measured as how force of gravity acts on that mass. Amount of matter in a body is measured by mass and Express by “m” or “M”. The amount of force acting on a mass due to the acceleration due to gravity is measured by Weight and it’s the result of Mass multiplied by acceleration of gravity (g).

The values for mass and weight are the same if it does not move on Earth. If you change your location from low to or high to low gravity then the Weight of the Object shall be change but its mass remain same in any location as mass is not location dependent. You can think that your mass of the body is always same but your Weight shall be different on Mars compare to Earth.

Difference Between Mass and Weight

Sl. No.	Differentiating Property	Mass	Weight
1	Definition	Mass is the measure of the amount of matter in a body.	It is the measure of amount of force acting on a mass due to acceleration due to gravity.
2	Criteria	Mass of an object is same in everywhere as Mass is a property of matter.	Weight always increases or decreases with higher or lower gravity as Weight depends on effect of the gravity.
3	Value	Mass is a constant Value and Mass can’t be zero in any place.	If no gravity acts upon an object, as in space then Weight can be zero as 0 [Zero] gravity acts on the mass.
4	Location	As per location, Mass does not change	Depends on location, Weight varies accordingly.
5	Denotation	Mass is denoted by “M”.	Weight is denoted by “W”.
6	Measurement	An ordinary balance can be used to measure Mass.	A spring balance is used to measure Weight.
7	Unit	Mass generally is measured in grams and kilograms.	Weight measured in newtons which is a unit of force.
8	Formula	Mass is always constant value for a body and there are several formulas to calculate the mass. Mass can be calculated as: Mass = Volume × Density	Weight is the measure of the gravitational force acting on a body. Weight can be calculated as: Weight = mass × acceleration due to gravity[g]
9	Gravitational Effect	Mass does not depend upon gravity and is constant everywhere in the universe.	Weight is dependent on gravity and so, it varies from place to place in the planet.
10	Measuring Instrument	Mass can be easily measured using any ordinary balance like beam balance, lever balance, pan balance, etc.	Weight can be measured by a spring balance or by using its formula.

If I go other Planets then How Much I Weigh on there?

Due to acceleration to gravity the weight varies dramatically but person’s mass doesn’t change elsewhere in the solar system. The “surface” distance from the center of gravity plays a major role to calculate the gravity on the mass. When you travel on the top of the mountain [The Himalayas] your weight shall be slightly lower than the sea level. Always mass is not the major as mentioned before, distance plays a significant role.

Suppose, If I in Saturn, my weight will not increase Saturn 95.2 times as Saturn is 95.2 times heavier than earth due to its surface is so much far [1.4075 billion km from Earth] from the center of the earth. To get the actual weight of a person just multiply the appropriate number of Earth Gravity. For Example, 100-pound person shall be weight on 113.9-pound on Saturn or 1.139 times weight on Earth.

Different Surface Gravity on different Planet

Particulars	Multiple of Earth Gravity	Surface Gravity (m/s2)
Earth	1 (defined)	9.8226
Jupiter	2.640	25.93
Mars	0.3895	3.728
Mercury	0.3770	3.703
Moon	0.165	1.625
Neptune	1.148	11.28
Sun	27.90	274.1
Saturn	1.139	11.19
Uranus	0.917	9.01
Venus	0.9032	8.872

Above the explanation, your weight will be same in Venus as the planet has the same size and mass as Earth. You feel slightly higher weight in Neptune and Saturn but less feel in gas giant Uranus. Almost same weight shall be assumed in Mercury and Mars though Mercury is much smaller than Mars[30% wider than Mercury].

If sun become cold [not possible in near future as assumed] you will feel 28 times much weight compare to Earth surface as it’s the more massive in our solar system.

What is the difference between Mass and Weight? Read More »

Data Integrity and Why Is It So Important?

GMP, Pharma Operations, Quality Assurance

Data Integrity can be defined as it is critical part to the plan, execution & practice of system that processes, stores & or retrieves data and maintenance & assurance of data accuracy and consistency throughout its life cycle.

Another best alternative term is Data quality which is sometimes defined as the proxy term of data integrity. It is the wide term & it can be used in different meaning depending on the framework. For data integrity, data validation is prerequisite. Data corruption is the just opposite term of Data integrity.

Also Read

What is the difference between Data and Information?

Confirm that data is recorded exactly as projected and most of the cases Data Integrity technique is the same for all type of probable data source.
The main target regarding is to prevent any type of alteration of the exact data recorded during collection of data and it can’t change at any cost. At the time of retrieval of data, it must be same as collected before.

Data Integrity denote the accuracy & consistency of data over its lifecycle. Sensitive data may loss upon uses of Negotiated data. Under this consideration, continuing it is a main focus of many enterprise security solutions. During replicated or transferred of data, it shall be intact and unaltered. To ensure the integrity of data, Error checking methods and validation procedures are typically best way to serve the same.

Don’t confuse with Data Integrity and Data security, it is process to prevent unauthorized entry to the projected data or protecting data from unauthorized expert.
Any unintended changes to data as the consequence of a storage, retrieval or processing operation, including malicious intent, unexpected hardware failure, and human error, is failure of data integrity.

Failure of Data Integrity means any unplanned changes to data as the consequence of storage, unexpected hardware failure, retrieval or human error or processing operation malicious intent etc. If you unable to protect your data from unauthorized change then it can define as data security failure.

Data Integrity denote that it is a state as well as process, so a confusion may arise. Data Integrity is a state as it denotes a data set is both valid and accurate. Validation methods & Error checking are considered as Data Integrity processes.

Study of Data Integrity

Data Integrity is significant for several reasons & need to maintain the same. Data Integrity confirms searchability, recoverability, connectivity, & traceability. To increases stability & performance as well as improving reusability & maintainability; need to protect validity & accuracy of data. Data plays a major role to drive enterprise decision-making and data undergo several stages of changes to form raw to format to become more practical and identifying relation between them. In modern enterprises Data Integrity consider the top most priority.

In a database system, Data Integrity may be Compromised in various type of ways. In the following ways, Data Integrity may be compromised-
[][]Compromised hardware, like device or disk crash
[][]Compromise of Physical devices
[][]Cyber threats, Bugs, Viruses/Malware, Hacking, & other unfamiliar process
[][]Human error, whether unintentional or malicious

Transfer errors, unintended alterations or data compromise during transfer from one device to another device.
Most of the cases, some type of data security may protect this data compromises. Data duplication is the critical para meter for data security as well as data backup process.

Data Integrity & Databases

Data Integrity encompasses strategies for data specifying, retention, or guaranteeing the length of time data. Any lessening of enforcement could cause errors in the data; all of the rules shall be consistently & regularly implemented to all data entering the system.

At time of data input, checking system shall be implement which will lessen up the number of data error for the system. Data Integrity rules shall be strictly implemented to the system which will save troubleshooting time, erroneous data subsequently errors to algorithms.

A standard Data Integrity rules must have the strict definition regarding data relation; as which type data shall link with which type of data. A selling record of a item of certain product may be linked with the specific product but is shall not be related to unrelated data such as company asset, policy, loan, promotion etc. Based on predefined rules, it may be included check & correction system for the invalid a data.

Data derivation rules shall be applicable, mentioning data derivation procedure that how a data value shall be derived based on contributors, conditions and algorithm of the system. Re-derived procedure for data value shall be mention on which condition shall be considered for this process.

Types of Data Integrity

Organizations can maintain Data Integrity through integrity constraints, which define the rules and procedures around actions like deletion, insertion, and update of information. The definition of Data Integrity can be enforced in both hierarchical and relational databases, such as enterprise resource planning (ERP), customer relationship management (CRM), and supply chain management (CRM) systems.

Organizations can achieve it through the following:

Physical Integrity

Physical integrity deals with challenges which are associated with correctly storing and fetching the data itself.

Physical integrity indicates the right storing & fetching the data itself & its associated series of challenges. Various types of Challenges are involved with it such as Physical flaws, design flaws, power outages, electromechanical faults, corrosion, material fatigue, natural disasters, environmental hazards such as ionizing radiation, high temperatures, pressures & g-forces [the force of gravity].

Various methods are available to maintain the physical integrity such as UPS [uninterruptible power supply], redundant hardware, various type of RAID arrays, error-correcting memory, radiation hardened chips, clustered file system, watchdog timer & cryptographic hash function for critical system.

Error-correcting codes is extensively use as error detecting algorithms in Physical integrity of data management systems. Simpler checks & algorithms as the Damm algorithm or Luhn algorithm is use to detect Data Integrity errors. This system is use to uphold Data Integrity at manual transcription from one computer system to another computer system through a human intermediary such as credit card numbers. Hash functions are more beneficial to detect Computer-induced transcription errors.

These techniques are used together to ensure various degrees of Data Integrity in production systems such as a fault-tolerant RAID array may be use to configured a computer system but in silent data corruption block-level checksums might not provide.

In a nutshell, Physical integrity means protecting the accuracy, correctness, and wholeness of data when it is stored and retrieved. This is typically compromised by issues like power outages, storage erosion, hackers targeting database functions, and natural disasters, which prevent accurate data storage and retrieval.

Logical Integrity

It is concerned with correctness or rationality of a piece of data provide a particular context. It denotes the topic such as Entity integrity & referential integrity in a relational database system. Design flaws, software bugs, and human errors are the major challenges. Foreign key constraints, check constraints, program assertions, and other run-time sanity checks are the common methods to ensure logical integrity.

Design flaws & Human errors, both are the common problems for physical and logical integrity which must be properly deal with the contemporaneous requests to record and retrieve data. Physical error for a specific data system is more critical than logical error. If a data system suspected to logical error, it can be reused by overwriting with the new one but if it faces physical error then the data sector is totally used of its own condition.

Logical integrity ensures that data remains unchanged while being used in different ways through relational databases. This approach also aims to protect data from hacking or human error issues but does so differently than physical integrity.

Logical integrity comes in four different formats:

Entity Integrity

Entity integrity is a feature of relation systems that store data within tables, which can be used and linked in various ways. It relies on primary keys and unique values being created to identify a piece of data. This ensures data cannot be listed multiple times, and fields in a table cannot be null.

Referential Integrity

Referential integrity is a series of processes that ensure data remains stored and used in a uniform manner. Database structures are embedded with rules that define how foreign keys are used, which ensures only appropriate data deletion, changes, and amendments can be made. This can prevent data duplication and guarantee data accuracy.

Domain Integrity

Domain integrity is a series of processes that guarantee the accuracy of pieces of data within a domain. A domain is classified by a set of values that a table’s columns are allowed to contain, along with constraints and measures that limit the amount, format, and type of data that can be entered.

User-defined Integrity

User-defined integrity means that rules and constraints around data are created by users to align with their specific requirements. This is usually used when other integrity processes will not safeguard an organization’s data, allowing for the creation of rules that incorporate an organization’s Data Integrity measures.

Types of Integrity Constraints

A set of integrity constraints or rules are followed to implement Data Integrity in a database system. Relational data model suggests the three types of integrity constraints such as domain integrity, entity integrity, & referential integrity.

First of all, Entity integrity denote the concept of a primary key. As per this system, Entity integrity states that every table shall contain a primary key and existing column or columns of the table shall be identified by the primary key & it shall be inimitable and not null.

Concept of a foreign key denote Referential integrity. As per referential integrity rule, any foreign-key value can only be in one of two states. In general condition, foreign-key value refers to a primary key value of some table in the database system. Sporadically, a foreign-key value can be null and this will rest on on the rules of data owner. Under these circumstances, it can be stated here that this relationship is unknown or there is no relationship between the objects represented in the database system.

All columns in a relational database must be stated upon a defined domain is the main concern of the Domain integrity. In the relational data model, the primary unit of data is the data item. This type of data items is known as atomic or non-decomposable. A set of values of the same type is defined as domain. Actual values appearing in the columns of a table are drawn from the Domains which are considered as pools of values.

As the User-defined integrity are set by the specific user with a set of rules which is not related to domain, entity, and referential integrity classes. The database which supports these features, it is the sole responsibility of the database to confirm Data Integrity and reliability model for the data storage & retrieval system. The database which does not support these features then it is the accountability of the applications to confirm Data Integrity though the database supports the consistency model for data storage & recovery process.

A well-controlled single and well managed data-integrity system increases.

[][]Maintainability
=>All Data Integrity administration commences from a single centralized system.

[][]Performance
=>As a single operation unit, all Data Integrity operations perform as consistency model.
[][]Re-usability
=>A single centralized Data Integrity system provides the all applications benefit.
[][]Stability
=>As avoid the multiple system, so Data Integrity operation performs sound as well as better retrieval on a one centralized system.

Examples
Data-integrity mechanism is often considered as the parent-and-child connection of interrelated records. When one or more related child records exist for a parent record then all of referential integrity methods are handled by database itself & inevitably ensures accuracy & integrity of data, so no child record can exist without parent record and subsequently no parent drops their child records. In this system if the parent record owns any child records, then no parent record can be deleted and all of the process handled by the database system.

File systems

File system including Ext, JFS, UFS, XFS, and NTFS or hardware RAID solutions can’t provide satisfactory protection against Data Integrity problems. Some special file system such as BTRFS and ZFS use for silent data corruption can provide extra protection for data integrity. Upon provide this protection and being chance raise to corrupt the data then such file system can construct the data is widely known as end-to-end data protection.

Data Integrity as applied to various industries
[][]FDA has created the draft guidance for Data Integrity system as per 21 CFR Parts 210–212.[12] for pharmaceutical manufacturers. Same guideline has been developed by UK [2015], Switzerland [2016], and Australia [2017].
[][]Data Integrity also addressed by ISO as per ISO 13485, ISO 14155, and ISO 5840.
[][]FINRA [Financial Industry Regulatory Authority], implement the Data Integrity system on 2018 under technology change management policies and procedures” and Treasury securities reviews as Data Integrity problem found in 2017 on automated trading and money movement surveillance systems.

Why Data Integrity Matter?

Now a days Data are becoming more available, a smart business strategy which are using to make decision are obtaining the several times benefits.
According to recent research, a data driven organization is more than 23 times better performer in customer acquisition, nine times more performer to retain their customer and more than 19 times profitable to their competitor.

As the power of data is increasing day by day, so Data Integrity shall be valued properly and its importance can’t be denied at current situation. Presence of any type of error in data can spoil the total organization goal. A data driven organization must protect their database system at any cost to provide better security solution.

Threats involve in Data Integrity

[][]Human error:
It may arise in such case of transferring of data manually from one share drive to another, copying data from one spreadsheet to another and subsequently deleting of row or column of a spreadsheet. Storing data on excel sheet may cause formatting problem during manually data transferring process. Updating of excel sheet from old version to new one may cause formatting problem of subsequent data.

[][]Inappropriate format:
Stored data on Microsoft excel based on cell referencing may not accurate in different format. Failure to determine the same may case Data Integrity problem.

[][]Collection error:
During collecting any type of data, proper precaution shall be taken. Collecting of data on wrong method may cause storing of incomplete data and actual data may not represent the total situation.

[][]Internal security breaches:
If the database system hacked by third part or internal or external competitor may cause serious Data Integrity failure.

Why is Data Integrity Important?

Generally, a specific individual or group of people are involved in database system of a organization. Problem arises when multiple people are responsible to operate the database system. Anyone of the team member may not aware about Data Integrity of the organization, then all of the individual shall educate regarding protection of the database system and tech them the importance of data quality, accuracy, completeness etc. & they must learn how to combat when potential data security threat arises.

If all of the team member are aware about the Data Integrity and know its importance then it is very much effect to maintain the database system.

A better Data Integrity system can save company effort, time as well as valuable overhead cost. Wrong decision may take place based on inappropriate data. Data driven organization always take critical decision based on available data, if Data Integrity of that organization are compromised by any situation, then inappropriate result may arise and the organization suffer in long run.

Data always help to make important decision additionally it protect your company image. If you are collecting your customer information then protect the collect data which you have collect from your individual customer, failure to protect the customer data in proper database system may leak your customer information to another one cause image problem of the company and also mispresent your customer to other party.

Any type of customer information may be tracked and may be asked or run a campaign over them to collect specific target data. All type of collected information may not be sensitive as SSN [Social Security number]. To protect your valuable customer, you have to take a proper step regarding Data Integrity of your existing system.

a company staff always demand to data access to the database to trace any type of data on time manner upon request. He needs to uninterrupted access to the data system. For this reason, Data Integrity is so important for the organization. Data Integrity confirm the traceability & searchability of the data from its mother source.

Effective data accuracy and data protection shall be confirmed to increase Data performance and its stability. It is very much crucial to confirm the completeness & integrity of data. Compromised data always carry the wrong value for the organization & is of no use for most companies.

Same scenario arises for big data management. It is very much important to secure the big data management system as well as to maintain the total database system. All type data is totally worthless Without integrity & accuracy. Your data can be compromised If you fail to do the same. Under this circumstances, awkward & expensive data audit trails shall be mandatory to find out error & recover the total database system.

Most companies have set specific goals for their data & it is now more important than ever. But if integrity is not assured then data is not of much use. If data loss, corrupted or compromised then data can considerably damage any type of business. To maintain it, data security shall be confirmed using proper tools.

Compromised Data is the big challenge to maintain data integrity. There are several ways to compromised the valuable data. Todays almost all of the data are digital and store then in the same than traditional method and its transferred vary rapidly in different places of the globe. So, security shall be considering first & also the collection data is main concert maintain its integrity.

Data can be unaltered if data transferring occur maintaining valid system. Every time Data is moving from one place to another and it is not static, every user of the specific system is using the data and transferring the same in different way.

Management of Data Integrity

A group of steps are available where you can maintain & achieve better Data Integrity for your organization.

Collection of Accurate, Complete, and High-Quality Data

Quality of data depends on the collecting process of the projected data; a collection process is crucial and collection depends on the proper collection method. Failure to select proper data collection technic may cause collection of erroneous data. Sourcing is prerequisite to collect data. Ensure the high-quality data source may provide one step forwards to competitor.

Meticulously Check for Errors

To make common error during collection of data is the main problem of manual collection of error but it can be rectified successfully to involve the second one to the same project. Various type of error can be overcome if proper checking process can be initiate by appropriate body. For most critical data double check or triple check can be initiate. Growing continuous attention during data collection may reduce the data error. Sometime a review of the related data may decrease the data error. A color shading on projected excel sheet in the alternative row may help to track the mentioned data.

Cybersecurity Threats

Most of the time you can’t realize that a hacker or third party is trying to access your database. Person or individual who are trying to control your data send a short link with attractive or recent hot topics or similar to company email address link. Thousand of ways a hacker can try to damage or control your database system, so a strong security system shall be established to protect Data Integrity of the system.

Data Science Course

Failure to know the technical framework of database system, you can’t protect your data properly. If you are capable to handle the system then you need not to collect data science but if you want to update your existing your practice and eagerly want to update your team capability then you can involve your team in any data science course which are already available online which help your organization as well as development of self-confidence.

Devotion to Data Integrity

To keep subjects’ information safe & giving organization’s stakeholders the highest quality, accurate, complete, most data on which to base decisions need daily commitment for your Data integrity. A proper security system and group of trained individuals can support the organization in this situation to continue the company progress.

Data Integrity vs. Data Quality

Data quality is a crucial piece of the Data Integrity puzzle. It enables organizations to meet their data standards and ensure information aligns with their requirements with a variety of processes that measure data age, accuracy, completeness, relevance, and reliability. Data quality goes a step further by implementing processes and rules that govern data entry, storage, and transformation.

Data Integrity vs. Data Security vs. Data Quality

Data security involves protecting data from unauthorized access and preventing data from being corrupted or stolen. Data Integrity is typically a benefit of data security but only refers to data accuracy and validity rather than data protection.

Data Integrity & data security are more relevant to each other. Each of them plays a vital role for each other for their individual achievement. Data Integrity only refers to validation and accuracy of data but didn’t involve to protect data. On the other hand, data security confirms the protection against corruption or unauthorized access.

Data security plays a crucial role to maintain data integrity, on the other hand, Data Integrity is the end result of data security. To maintain data integrity, data security is the vital point and this situation may arise when accidental compromise occurs for data integrity.

Data Integrity is the essential component for the modern business procedure while making decision based on accuracy and efficiency of database. The main focus of the data security leads to Data Integrity and various type of procedure are applied to achieve the same.

Data quality can be defined that the data stored in database is compliant with the organization’s standards & requirements. It maintains integrity in a database. A set of rules to a specific or whole dataset and stores it in the target database shall be implement to do the same. Data Integrity shall be considered as data accuracy as well as correctness of data.

How to Protect Your data?

Validate Input

To ensure data accuracy data entry must be validated & verified input is significant when data is provided by familiar or unfamiliar sources, such as end-users, applications, & malicious users.

Remove Duplicate Data

Sensitive data stored in secure databases cannot be duplicated & it important to ensure that publicly available spreadsheets, emails, documents, & folders. To prevent unauthorized access to business-critical data or personally identifiable information duplicate shall be remove as soon as possible with the help of authorized personnel.

Back Up Data

To confirm data security & integrity data backups are crucial. To prevent the valuable data from permanent lost data backup shall be perform on regular manner at the end of everyday work. Organizations that suffer ransomware attacks, Data backups are especially important for them to protect their potential resources.

Access Controls

To maintaining data integrity, appropriate access controls shall be introduced in the organization. Data privileged option shall be implemented for specific user to control the database access procedure. This process will help the user understand their limitation to use the database system as well as to maintain the whole system.

Audit Trail

An audit trail is the standard practice to trace the unfavorable event. Data breach may occur at anytime in a renowned organization. If audit trail facility are available for the organization then it is very much to find out when and how data breached where. If proper information is available then it is easy to trac the source of attack. So audit shall be introduce at your organization for your database management system.

Assurance of Data Quality

It is the part of the Data Integrity process. Regular shall be conduct so that data can meet the certain standard. The processes of data accessibility, data cleaning, , data standardization is the main concern of the Data quality assurance. Data cleaning deal with inputting missing data, removing invalid entries, update same on timely manner.

Data accessibility deal with availability of the data to the stakeholders in secure and appropriate manner. For encoding and entering data, business shall be maintained and unauthorized data entry or transfer shall be prohibited. All type of company rule shall be implemented increase of transfer access of data to potential sector.

Data Corruption vs Data Integrity

Data corruption shall be considered as the serious Data Integrity failure. Based on the current practice, data corruption may be occurred through multiple channels. Most of them a very common problem is human error occur during collection or transferring of data. Malware and physical damage are another potential cause of data corruption.

Most human error often cause in wrong entry of collected data, unauthorized entry of database system, involving newcomer to sensitive practice with our prior training, programming etc.

It can be traced with appropriate data validation checks & restricting access to database system. Extensive & systematic use of backups can support restore databases in case of improper data entries.

Malware is another common cause of data corruption and this is basically occurred from external source which main purpose is to stole the data from potential data server. Cyberattacks are almost always unpredicted and instantly can’t recognized the source on the most of the cases. So here come the data encryption, always try to encrypt the critical and sensitive data and if possible tight security system shall be introduced though cost may be high to do the same.

To ensure organizational network security, regular penetration testing shall be done, this will help you to secure the organizational network system. A physical damage is may cause the data lose which mainly cause by accident and disasters. To protect data, data may be store in different physical location will protect from accident and natural disasters.

Data Integrity and Why Is It So Important? Read More »

What is the difference between affect and effect?

FAQ, Pharma Operations

Affect & Effect

These two words are verbs & nouns and their meanings overlap. It is not possible that whose word come first in English language. In general, Affect is used as Verb and effect as a Noun.

Meaning of Affect

[][]Affect means Change in something, to act on.
“The hot weather affected the iceberg.”[The hot weather produced a change in the iceberg.]

[][]To amaze the mind or move the feelings of,”
“Billie Eilish song ‘lovely’ deeply affected her.” [The music changed his moods or thoughts].

[][]You can also change the word Affect with Right word
“The hot weather damage the iceberg.”
“Billie Eilish song ‘lovely’ deeply moved her.”

To express a change or to describe an action, the word “Affect” shall be use.

Meaning of Effect

Effect means “result” or “consequence.” & Most commonly used as a noun. Effect can be replace with another noun.

“His high market share value was an effect of ownership change of the company” Another way to say it is, “His high market share value was a result of ownership change of the company”

Remember Difference Between Affect & Effect

[][]Memorize the word RAVEN; you can easily differentiate them_

R = Remember
A = Affect is a
V = Verb
E = Effect is a
N = Noun

There is another way to remember when to use affect and effect:
[][]A is for action (affect); E is for end result (effect).

Example

Affect

[][]Almost always used as a verb to mean to influence someone or something.

How does one’s creativity affect success on the project?
These songs will affect the number of people who will come to the outdoor concert.

[][]Affect can be used as a noun in one particular situation.
The old man’s facial expressions had a humorous affect.

Effect

[][]Most often used as a noun. It denotes an event or a thing. Often used when result is being discussed.

What effect did the job of company on his family?
Did his sudden retirement have any effect on his family?

[][]Effect can words like : on, the, any, into, , take, an, or.
The prescribed pill had an effect on the patient’s symptoms.
We have to consider the changes time to take effect.

[][]Effect can be used as a verb in one particular situation.
The new management is responsible to effect negative changes in the office.

What is the difference between affect and effect? Read More »

What is the difference between Data and Information?

Documentation, Pharma Operations, Viva

Most of the cases we think that “data” and “information” are same but they actually aren’t the same though they are often used interchangeably. There are elusive differences between these two components & their purposes of use. information is organization & interpretation of group of facts where Data is defined as individual facts. To identify and solve problems, you can use the data & information together. To drive a successful business, we can use these two components to accelerate the ultimate mission to reach the goal.

What Is Data?

Collection of individual facts or statistics is defined as data (Data is plural form of ”datum” but the term didn’t use in for daily expression. Data has its various type of form such as figures, text, observations, numbers, images, graphs, or symbols. Individual dates, prices, weights, addresses, ages, temperatures, distances, names, etc. can the example of data.

Data is simply defined as “facts & figures”. Each piece of data is a tiny fact that doesn’t mean abundant of its own. Data can be defined for singular fact or collection of facts. It comes from the Latin word ”datum”, mean “something given”. “datum” is technically correct singular form of data but is hardly used in public language. Its early usage dates back to 1600s. Over time “data” has become plural of “datum”.

Data doesn’t carry any significance or purpose, it’s the raw form of knowledge. To make it meaningful you have to interpret data. Bits & bytes are used to measured data which are units of information in context of computer storage & processing the same.

Data without analyzed, organized, and interpreted may even seem useless & data can be simple. Two types of data are depicted here-
[][]Quantitative data is in numerical form, like volume, weight, cost of an item. Its not descriptive.
[][]Qualitative data is descriptive, like sex, name, or cloth color of a person. It’s not but non-numerical.

What Is Information?

It can be defined as act of knowledge gaining process through research, study, communication, or instruction. Information is the totality of group of analyzed and interpreting data. A data is always the individual numbers, figures, or graphs whereas information is considering the perception of those items. In this era, we can mention that most of the sophisticated modern industry always maintain environmental monitoring through recording of Temperature & Relative Humidity, through out the year of the year and achieve it in a suitable position.

Information can be defined as “news or knowledge received or given”. Processed, interpreted & organized facts is information. It comes from the Latin word īnfōrmātiō, mean “formation or conception.”

This type of recoding doesn’t bear any significant meaning but if you organize, analyze the recoded data then you can easily realize the Environmental condition changes in specific season. You can trend the data to sort out the best matching, minimum maximum data etc. which useful to set up or install the best quality BMS [Building Management System] parameter. Without analyzing and organizing the data, it is the just piece of recording doesn’t denote any significant value. A well-organized data can help the others.

In basic terms, it can be concluded that data is unorganized explanation of raw facts from which information can be take out.

Significant Differences Between Data vs Information

[][]collection of facts is considered as Data where information puts all of those facts into context.
[][]Data is always raw & unorganized where information is processed and organized.
[][]Data points are individual & most of the time it is unrelated. Information relates these points and show the actual behind it.
[][]Without analyzed and interpretation data is totally meaningless, when it organized then it became meaningful information.
[][]Data is always independent but Information depends on data due to you can’t get any information without processing data.
[][]Numbers, graphs, figures, or statistics is the form of data. Information generally appears as language, words, thoughts, ideas etc.
[][]To base on data, you can’t make any decision but when information available at your hand you can make any decision. So, data are not enough to make any decision, information require to do the same.
[][]Data always defines figures & facts. It comprises of one entry or collection of diverse values. Information defines values & context together, resulting in approximately meaningful. It forms an organized & interconnected structure, from data, to interpret or link the whole.

[][]Example
=>For data examples, we can use Lance, M. Kiely, 4590 Neville Street, Terre Haute, IN 47807. The separator [commas] characterize each distinct fact that may or may not be linked to others.
=>In this example of information, Each fact narrates to other facts to form a concept, known as Lance M. Kiely. Creating this Lance M. Kiely entity allows people to reason, calculate, & do other influences.
Lance M. Kiely
4590 Neville Street
Terre Haute, IN 47807

Data vs. Information in Computers

If we consider computers, Data can be considered as INPUT on anything that instruct to computer to do or store. The OUTPUT of the computer which exhibit your computer after your instruction to computer.

As per statistics, data defined as raw information but term statistics is often used in place of information. Statistics interpret & summarize data.
In business, data are often raw numbers & information is a collection of separate data points which you use to realize what you’ve restrained.

[][]1.0
Data: typing the words “Dog videos” in your computer web search engine (INPUT).
Information: The list of search results which includes a variability of dog videos on the resulted browser page (OUTPUT).

[][]2.0
Data: 9994565566
Information: phone number (555)456-5566 of a person.

[][]3.0
Data: 46.07 & 789
Information: Molar mass & Density of Ethanol in g/mol & kg/m³

[][]4.0
Data: 70%
Information: Isopropyl alcohol in percentage

[][]5.0
Data: -16
Information: Freezing points of Vodka in Fahrenheit

Difference Between Data and Information

Parameters	Data	Information
Content	Unrefined raw factors.	Refined in a meaningful way.
Characteristic	Data is considered property of a specific organization & is not offered for sale in the public.	Information is offered for sale to public.
Decision Making	Raw data is insufficient to make any decision.	Information is enough to make any decision.
Dependency	Data depends upon the sources for collecting method.	Information always depends upon data.
Design of Data	Data is never designed for specific need of user.	Information is always explicit to requirements & expectations because all extraneous facts & figures are detached, during transformation process.
Dependency level	Data never depends on Information.	Information constantly depended on Data.
Description	Helps to develop ideas or conclusions based on Qualitative or Quantitative Variables.	It is group of data which carries news and meaning.
Etymology	Data has comes from Latin word, datum, means “To give something.” The word “data” become plural of datum.	It comes from the Latin word īnfōrmātiō, mean “formation or conception.”
Example	1.0 During word Tour Ticket sales on a specific Band.	1.0 Sales report generate by region & venue gives information which venue perform best.
Example	2.0 An example of data is a student’s Eye Color.	2.0 The average Eye Color of a class is the information derived from the given data.
Format	Data found in the form of letters, numbers, or a set of characters.	Ideas and inferences
Feature	Data is a single unit & raw. It doesn’t have any meaning alone.	Information is artefact & group of data which jointly carry a logical meaning.
Interrelation	Collected Information.	Processed Information.
Knowledge level	Low-level of knowledge.	Second level of knowledge.
Meaning	Data does not have any definite persistence.	It conveys meaning that has been allocated by interpreting data.
Measuring unit	Measured in bits & bytes.	Measured in different meaningful unit like time, quantity, etc.
Meaning of base	Data is based on records & explanations and, which are deposited in computers or remembered by a individual.	Information is considered more consistent than data. It helps investigator to conduct a appropriate analysis.
Support for Decision making	Data can’t be used for decision making	It is extensively used for decision making.
Significance	Data collected by the researcher, may or may not be useful in different situation.	Information is useful & appreciated as it is readily accessible to the researcher for use.

List of Examples of Data vs Information

differences between data and information, how these examples turn data into insights:

[][]An individual customer’s bill amount is data at a specific restaurant but after a certain period of time or after one day collection when the restaurant Manager or owner collect all the customer bill of that day or time, it can produce valuable information of the restaurant as it can produce which item of the restaurant is hot cake or what item is running well and what are not. After that the restaurant, can realize how they can maintain the inventory of a specific item and how to continue their service as well as to minimize the overhead, wadges, supplies etc.

[][]An individual customer service survey of a restaurant is a data but after a period of time when compile the all the survey, then it can produce valuable data regarding area of improvement of the restaurant such as customer service, price, cleaning, mannerism, hospitality, space, location, viewpoint etc.

[][]A single social media like on a media post is a data but when multiple social media item like comments, share, statistics etc. are compiled then the specific company can focus on the specific social media where they are performing best and where they are in worst condition. Comments from a social post of multiple social media is very useful to do the same. It helps the company to set their goal based on the comments collect from customer and it help to find out multiple idea from multiple customers.

[][]On their own, inventory levels are data. However, when companies analyze and interpret that data over a range of time, they can pinpoint supply chain issues and enhance the efficiency of their systems.

[][]Inventory management of the company for the different item is the data but when it collects for certain period of time it can be valuable information regarding the inventory item which can help the supply chain management system to run their activity appropriately.

[][]A Price of a specific item is a valuable data but when processing the data from multiple company can produce valuable information regarding market gap, advantage of the competitor, profit margin, bonus, discount, policy etc. for the specific item.

[][]Taste of Azithromycin Suspension is a data but when you collect different taste from different company product you can produce valuable information regarding taste that which taste is more acceptable to the end user i.e., mango/orange/strawberry/pineapple etc. from this activity you can collect valuable information and implement the same for your company product.

[][]Temperature readings all over the world for the past 10 years can be consider as data. When this data is organized, analyzed to find out global temperature condition is raising over the period of time, then this data changed to information.

[][]Number of visitors to a specific website by country of the word is an example of data. Finding out that the traffic source from Canada is decreasing while that from Austria is increasing is meaningful information.

[][]Often data essential to back up a claim or supposition consequent or inferred from it. Such as before a drug is approved by FDA, manufacturer must conduct clinical trials & must have submit lot of data to reveal that the drug is safe.

“Misleading” Data

[][]Due to the processing of data, interpreted & analyzed, this is very possible that it can be interpreted incorrectly. When this leads to specious conclusions, it can be said that data are misleading. Often this is the consequence of imperfect data or a lack of framework. Such as your investment in a mutual fund may be up by 7% & you may accomplish that fund managers did a great job. Nevertheless, this could be misleading if major stock market indices are up by 10%. In this case, the fund has floundered the market pointedly.

[][]In the year of 2007, Famous toothpaste company Colgate ran an ad campaign & stating that 80% of the dentists recommend Colgate Toothpaste for safe dental health. From this promotion, many consumers assumed that Colgate was the best choice for their safe dental health for daily use. But in practical, this wasn’t inevitably true. In reality, this is the well-known example of misleading data & information.

[][]Anchor Tucker Carlson presented a graph saying, number of Americans recognizing as Christians had distorted over last decade during one of Fox News’s broadcasts. Over the image above, a graph showing in 2009, Christian Americans is 77%, number decreased to 65% in the year of 2019. Now, if issue here is not noticeable enough, here the Y-axis in that chart starts from 58% & ends at 78%, making the 12% drop from 2009 to 2019 look way more substantial than it really is.
Sample size is the vital point to make any key decision for the organization. Making any decision data collected from 100 sample is more accurate data collect from 10,000 sample. Data collect from 100 sample is misleading compare to 10,000. A key decision shall be make from vast amount of sample.

[][]Federal Trade Commission (FTC) filed a lawsuit against car company Volkswagen , which claimed that car company had betrayed customers with advertising campaign it used to promote its allegedly “Clean Diesel” vehicles, according to a press release.

In the year of 2015, it was uncovered that Volkswagen had been cheating emissions tests for its diesel cars in US in the past 7 years. The Federal Trade Commission, alleged that “Volkswagen cheated consumers by selling or leasing more than 550,000 diesel cars based on the false claims that cars were low-emission & environmentally friendly.” For their false claim, the company was remarkably fine up to $61 billion for the violation of Clean Air Act.

[][]Red Bull, Energy drinks company was sued in 2014 their slogan “Red Bull gives you wings.” The company settled case by agreeing to pay out maximum of $13 million — including giving $10 to every US consumer who had bought their drink since 2002.

They claim that the caffeinated drink could improve consumer’s concentration & reaction speed; the tagline company use for last two decade went alongside marketing claims. One of the regular customers of Red Bull drink claim that that he had not developed “wings,” or shown any signs of enhanced intellectual or physical capabilities.

[][]In 2010, Kellogg’s widespread Rice Krispies cereal had a crisis when it was defendant of misleading consumers about product’s immunity-boosting properties. The Federal Trade Commission [FTC] ordered Kellogg to close all advertising which claimed, cereal enhanced a child’s immunity with “25 percent Daily Value of Antioxidants and Nutrients -Vitamins A, B, C and E,” affirming the claims were “dubious.”

[][]New Balance, the famous show making company [Owner, Jim Davis, own almost 95% total share of this company] was defendant of false advertising in 2011 over a sneaker range which claimed that it could help wearers to burn calories but it was subsequently found that there were no health assistances from wearing this sneaker range. From New Balance, they explain that using hidden board technology & it was advertised as calorie burners which activated the quads, glutes, hamstrings & calves. New Balance agreed to pay a settlement of $2.3 million on August 20, 2012.

How Businesses Can Leverage Data & Information

Is it come to the point to distinction between data vs information really matter for businesses? If any company that company collect accurate data then interpreting it and generate information and implement the same on right time on right place can realize the actual benefit for the company.
For example, a company might gather data about the performance of their ads or content. Running a successful add or content to the various platform can produce valuable data. From the data they can produce right information regarding product design, brochure generation, promotional activity, product awareness, customer demand and customer buying capacity.

This can also help to develop target customer, future offering, promotion, branding and developing multiple products for the company.
Right data can lead the organization to the right goal but to maintain the right set of data is very difficult. There are several blockades to create a data dependent better smart organizational culture. Different team of an organization may collect & maintain disparate sets of information. Hence a central database system is crucially need for the organization. Without a central database system, none one can earn the actual benefit and interpretation of data may fail. Data need to supervise by someone, without proper supervision data may not maintain its proper quality and generate poor data mislead the organization.

Any business depends on expressive data patterns to get information. There are dissimilarities between data and information. Business relies on meaningful data patterns to get information, in this article let’s explore the differences and similarities between data and information. Misinterpretation the difference between “data” & “information” sets up the stage for slip-ups. Like the six blind men in an Indian legend, trying to define an elephant, end up puzzling discrete facts, or data, as information or meaning.

In six blind men’s dilemma, individually complicates data (trunk or legs) for information (an elephant is like giant cow or an elephant is like a giant snake). Likewise, anyone can collect customer data & think they have the full customer information when they are actually not. Data & Information have specific implementation. To correctly recognize & use either one, you need to understand the change between data & information is.

To create an effective data driven organization, then you need to maintain the data source which must available across the group of qualified people who are technically sound to generate information from processed data maintaining appropriate protocol to assure the proper data quality.
Data is very critical to generate information and both these two items is crucial to make any decision for the organization.

DIKW [Data Information Knowledge Wisdom] Model

DIKW is the model used for discussion of data, information, knowledge, wisdom & their interrelationships. It denote functional or structural relationships between data, information, knowledge & wisdom.

Are data and information the same thing?

Data is based on observation & records which frequently store in computers or simply memorize it by individual. On the other hand, information denotes to be more consistent than data. In other words, it is a proper analysis which researchers or investigators conduct for converting data into information.

Data and information may be the same thing, From a content & format perspective. For example, you can point same values in two diverse columns on a spreadsheet. Nevertheless, data & information contents & formats do not have to match. In any case, you use data & information very in a different way.
If you want to sort out the value “New York, United States” You will filter data named “New York” under city and “United States” under country.

On the same spreadsheet, If you want to know if the Lance M. Kiely records mean the identical person. Then look at the information in both rows & see, across the columns:
Lance M. Kiely
4590 Neville Street
Terre Haute, IN 47807
You determine both Lance M. Kiely, living in New York, United States, mean the same customer thing from the information provided.

How do data and information differ?

Though Data & information may have the same values but from the creation & business usage they may differ. Data generally includes entries whereas Information contains context. Information comprise data with different contents & formats & be the same thing.

As per data perspective point, “United States,” “UNITED STATES,” and “U.S.A.” represent entirely different facts based on number of characters & formatting varies. Therefore, Lance M. Kiely, who lives in U.S.A., is not same customer as Lance M. Kiely, who lives in United States.

If we consider information viewing platform, the “United States,” “UNITED STATES,” & “U.S.A.” represent the same thing for geographical reason because someone with understanding of geography can point to the “United States” or the “U.S.A.” on a American Map.

The correct data and accompanying context make the United States and the U.S.A. contain meaning about a shared concept of that region, like culture, sports, and government. From the shared concept of that region, like culture, sports, and government make the data more accurate. Lance M. Kiely, who lives in U.S.A., with Lance M. Kiely lives in the United States, and consider creating the same object. Comparing with the other people lives in United States using additional data points like cultural activities in U.K.

Frequently Asked Questions

What is data? Explain with example.

Raw, unorganized, unprocessed facts are known as Data. All of the facts consider as data until it processed, organized such as all information writing on the paper is data until its processed & organized in suitable manner.

What is information?

Processed, organized data which is advantageous in providing useful facts is known as Information. For Ex. It can be concluded that if data are processed and organized in right way generate valuable piece of information.

What is valid information?

A reliable fact is considered as Valid information. Checked & verified information that is ready for use in a specific purpose.

What is the classification of Data?

Classification of Data

Data classification is a critical element of any information security & compliance program, especially if any organization stores big volumes of data. To understand the data security strategy, classification of data plays an important role providing information that where the sensitive data shall be stored. It provides valuable information regarding unused data & elimination of the same type reduce the maintenance cost for the organization.

Types of Data Classification

[][]Content-based classification inspects & interprets files to classify sensitive information.
[][]Context-based classification looks at location, application, creator tags & other variables as secondary indicators of subtle information.
[][]User-based classification depends on manual selection of each document by an individual.

Basic Classification Scheme

The modest scheme is three-level classification:

[][]Public data
Data that can be freely revealed to the public. Examples include any company contact information & any browser cookie policy.

[][]Internal data
Data that has low security level but is not for public expose, like marketing research for a product.

[][]Restricted data
Highly subtle internal data. Expose to public platform create negative impact on operations and put the company at financial or legal risk. Restricted data entails the highest level of security protection at any cost.

Government Classification Scheme

Government agencies use three levels of sensitivity as top secret, secret and public but based on situation can be classified into five types

[][]Top secret-Cryptologic & communications intelligence
[][]Secret-Selected military plans
[][]Confidential-Data signifying the strength of ground forces
[][]Classified-Data labelled “For Official Use Only”
[][]Unclassified-Data that may be publicly released after authorization of respective body.

Commercial Classification

Typically, organizations that store & process commercial data use 4 levels to classify data: 3 private levels and one public level.

[][]Sensitive- Intellectual property, Secrete Formulation, PHI
[][]Confidential-Vendor contracts, employee reviews, Contract, Special Allowance
[][]Private-Customer names or images, Sensitive Video promotion
[][]Proprietary-Organizational processes, Quality System
[][]Public-Information that may be disclosed to anyone

What is the meaning of the two types of data?

The two types of data are qualitative & quantitative. Qualitative data is non-numerical data like eye color, skin texture, Hair color, Shoe color, Clothing color and more. On the other hand, quantitative data is in the form of numbers like the weight of books, number of apples, number bird and more.

What is the difference between Data and Information? Read More »

Forced Degradation Study or Stress Testing Procedure

GMP, Pharma Operations, Product Development, R&D

What is Degradation?

Forced Degradation Study before proceeding on it ,first of all ”Degradation’‘ to be discuss first, This is the act of lowering to some degree or someone to a less respected state or position. A CEO of a multinational company resigning from his office is a degradation. It’s also a downcast state.

The word degradation is very much related to the degrade, which comes from Latin word Degradare. The word “Degradare” comes from “de”-, meaning “down,” & gradus, meaning “Step.” So, it is very much clear that the degradation as a step down, or feeling as though you’re a step below.

Degradation products

It is the unwanted chemicals which can generate during manufacturing, transportation & storage of pharmaceutical drug products & can affect efficacy of pharmaceutical drug products. A small amounts of pharmaceutical degradation products can affect crucial safety because of the potential to cause adverse effects in end user.

Subsequently, it is crucial to focus on formulation, storage conditions, transportation, distribution channel and packaging to prevent the formation of degradation products which can negatively affect quality, safety and efficacy of the pharmaceutical drug products.

To find out the main cause of degradation of the pharmaceutical product is the crucial point, various software and data tracking system can help in this matter. This system can provide useful information during transportation and storage of pharmaceutical products, the route shall be determined to estimate the main cause.

Presence of a genotoxic degradation product shall tend to more assessment if it identified on due time. The chemical structure of the substance shall be determined to identify the toxic alerting structures associated toxic products, products [Compound] without active structure is marked as ordinary impurities.

A risk/benefit analysis shall be done to evaluate the levels of degradation products and most of the nest pharmaceutical call its mandatory. During the development of any type of product either critical or non-critical drug, critical variable of the drug products shall be follow-up which will control the degree of degradation of impurities.

Now a days the impurity profile has been considered as the key point of the product quality. It is the essential part of the quality parameter for the various competent regulatory authority. The toxicological evaluation and impurity profile become the key point of the degradation products to confirm its certain level of efficacy. Various types of test method have been identified to investigate the degradation products, all of them assay method consider the best to all and it’s highlighted to prove its effectivity.

The purity, safety and efficacy of the product depend on the stability of the product and it is the critical parameter of all the parameter. A product must be stable at a certain period of time to prove its efficacy, potency and safety.

A less stable or changes of stability can create serious toxicological effect by forming toxic degradation products and deliver less active or less effective or less potent drugs to the end user. Under these circumstances, this is very crucial to known the actual behavior of the drug products in various surrounding or environmental conditions.

Dissolution test are considering the most quality control tool for the commercial batch to batch product to monitor its consistency over a certain period of time. It also provides significant information during post approval changes of the certain product as changes made in formulation, manufacturing process and different scale up procedure.

To confirm the quality, safety and efficacy, the chemical stability is very important for a pharmaceutical product. This is very important to know the environmental influences of a certain developed product in specific condition such as Heat [Temperature], Humidity [Relative Humidity] & Light [Photostability] and this also regulatory [ICH & FDA] requirements.

Data acquire from stability study denote the shelf life and storage condition of the specific tested drugs, the container closure system [Protective packaging system] also require to satisfy the regulatory expectation.

Different types of method/instruments are available to determine the degradant compounds which are readily present during the forced degradation study period. HPLC-UV [HPLC with UV detector] and HPLC-PDA [ HPLC with Photodiode Array Detector] is the renowned method and extensively used in pharmaceutical company at the time of degradation study and validation and development of various type of method.

LC-MS [HPLC with Mass Detector], GC-MS [Gas Chromatography with Mass Detector] and NMR [Nuclear Magnetic Resonance] spectroscopy are significant methods to detect the degradants’ structure.

What is Forced Degradation Study?

Go to top

Exposure of specific sample at the unfavorable/stress condition of Heat [Temperature], Humidity [Relative Humidity], Light [Photostability], Oxidation and Acidic/Basic condition; observe/detect the changes of those sample or measure the rate of changes/degradation, mainly in Efficacy, Safety and Potency parameter of drug substance. Forced degradation study is the key point during the development of a specific drug. Determination of the type changes denote the modification or changes of the development process.

Now a days Force Degradation Study become the prerequisite to submit the NDA to regulatory authority and it became the quality parameter for the new product. During the regulatory submission, the Force Degradation Study data shall be submitted to get satisfactory result from FDA. Some of the best application of Force Degradation Study is depicted here-

[][]Developing and validating stability study indicating method as per regulatory guidelines [ICH Guidelines].
[][]To set up specification of degradants or impurities and to identify structure and toxicity.
[][]To set propose shelf life the specific product without performing Realtime stability data.
[][]To avoid incompatibility of drug products and excipients.
[][]Determination of the process related degradation products or impurities.
[][]Provide supporting data to lab investigations/OOS [out-of-specification] analysis.
[][]To provide regulatory compliance documents during submitting of ANDA/NDA to FDA.

It is a useful tool to predict the stability of any Active Pharmaceutical Ingredient (API) or formulation product. It helps to know about the impurities developed during the storage of drug products in various environmental conditions.

Forced degradation is performed by applying artificial methods and a drug is degraded forcefully. It is also known as stress testing. To assume the stability condition of API [Active Pharmaceutical Ingredient] and formulated product Forced degradation study plays an important role. It also helps to identify the impurities generated during storage of drug products in different environment stage.

process flow diagram of forced degradation study

Why Forced degradation study carried out?

Go to top

Its play a vital role to develop and validating of stability study signifying method. At the time of developing phase of a new drug product, force degradation study performs to determine the degradation pathways of drug products & drug substances. It is very important to determine impurities of the degradant product, Forced degradation study quantify the number of impurities present on the specific drug substance. It helps to determine the molecular chemistry. Forced degradation study assure the more stable product. Help to develop the degradation profile. Stability related problem can be solved through Forced degradation study. Forced degradation study also highlight the following point of view-

[][]Evaluation of drug products & drug substance in solution.
[][]Determination of structural transformation of drug product & drug substance.
[][]Determination of the concentration of the degradation products.
[][]To identify the non-relevant impurities in the existence of the desired product.
[][]Separation of the product related degradants derived from intact placebo & excipients.
[][]Describe the degradation pathways of the specific drug substance.
[][]To categorize the degradation products which generate spontaneously during storage & use of products.
[][]To generate product related variants & develop analytical methods Forced degradation studies are performed during accelerated and long-term studies.

During the Forced degradation study, the degradation products may or may not be generate but it will show the degradation pathway of the product. This process will help them develop the analytical method of the relevant product and stability indicating analytical procedure. If any degradation occurs during performing of Forced degradation study, the degradation product shall be evaluated if it significant or minute, to robust the developed formulation.

How Forced degradation Study Conducted?

Go to top

This study of the drug products or substances is generally conducted on the solid and solution stages at the high temperature exceeding accelerated stability condition which is above 40°C. Various condition are consider here as oxidation, hydrolysis, photolysis, polymerization and thermolysis. In Solution hydrolysis condition are investigated in broader pH range and in solid stage high relative humidity taken under consideration.

Control exposure of molecular oxygen or addition of oxidizing agents such as peroxides is use during investigating Oxidation in solution.
Applying heat in solid state effects of thermolysis are usually assessed. Light with wavelengths in the 300-800 nm range are use in Photolysis investigation in solution or the solid state. In an oxygen atmosphere photooxidation can be investigated with light under oxygen atmosphere. Measuring the rate of degradation, Drug substance polymerization can be investigated at the various drug substance concentrations in solution.

List of Analytical Tools to perform Separation & Identification of degradant

A. Sophisticated Techniques

[][]Capillary Electrophoresis- Mass Spectrometry [CE-MS].
[][]Gas chromatography–mass spectrometry [GC-MS].
[][]Liquid chromatography–mass spectrometry [LC-MS].
[][]Liquid Chromatography- Nuclear magnetic Resonance [LC-NMR].
[][]Liquid chromatography-Fourier Transfer Infrared [LC-FTIR].

B. Conservative Techniques:

[][]Thin layer chromatography [TLC].
[][]Solid phase extraction [SPE].
[][]Accelerated solvent extraction [ASE].
[][]Low-pressure LC [LPLC].
[][]Supercritical fluid extraction [SFE].
[][]Mass Spectrometry [MS].
[][]Nuclear Magnetic Resonance [NMR].
[][]High Performance Liquid Chromatography [HPLC].

Extend of degradation

For validation of a chromatographic purity assay, degradation level of 10-15% is adequate to perform the activities. Forced degradation studies are not considered part of the formal stability program though forced degradation studies are a regulatory requirement & scientific necessity during development of a specific product. For conducting studies at the various phases of development the guidance gives various recommendations.

Selection of Forced Degradation Condition

Go to top

In common industry practice, forced degradation is generally performed in different stress conditions, i.e., thermal, acid, alkali, peroxide, and UV, along with a control sample which also comply with ICH guidelines. There no specific range or rate of degradation in current industry practice but 5 to 30 percent degradation shall be taken into consideration and this can be achievable on any one of the above stress conditions.

Through stress testing, the aim of the degradation to be achieved to implement the control room temperature for the stability conditions. The conditions or concentrations of reagent shall be optimized if higher or lower degradations are observed.

During the degradation study Mass balance shall be demonstrated & it shall be around 100%, taking into attention margins of analytical errors. During mass balance evaluations, all the degradants /impurities must be calculated.

Any batch which is not be the part of regulatory submission can be used for the forced degradation study. For multiple strengths of the same placebos and different amounts, the highest ratio of placebo vs. API [Active pharmaceutical ingredient] shall be use.

Forced degradation of all the strengths shall demonstrate if placebos are different. Placebo & API [Active Pharmaceutical Ingredient] must be demonstrated to identify actual degradation pathways during the drug product force degradation study. All the placebos shall be considered for force degradation study if placebos are different for different strengths of drug product.

Various degradation conditions are depicted on the following table which is accepted by the regulatory authority [FDA] at the time of DMF/ANDA/NDA submission-

Degradation Type	Reagent Concentration	Conditions to be applied	Time	Remarks
Acid	5N HCL	80deg.C	1 Hour	Concentration, condition and time can change to optimize degradation
Alkali	5N NaOH	80deg.C	1 Hour	Do
Peroxide	10% H2O2	80deg.C	1 Hour	Do
Heat/Thermal	80deg.C	80deg.C	1 Hour	Do
UV	Expose under UV light at 254nm wavelength	Ambient Temperature	24 Hours	Time can change to optimize degradation
Control	N/A	N/A	N/A	N/A

Force Degradation shall be performed in solid or solution form though it is recommended that Force Degradation shall be executed in solution form using the mobile phase/diluent to get a homogeneous effect with better result. Force Degradation studies shall be started with harsh conditions (i.e., high temperature with high concentration of reagent) to shorten time of study.

Milder conditions shall be applied by reducing concentration of reagent with lowering temperature, etc. when degradation found 30% or above. Based on the initial degradation outcome, Degradation conditions can be optimized to achieve a target range.

To extend shelf life of chromatographic column, pH shall be adjusted about 7.0 for acid & alkali degradation. Different reagents & conditions shall be applied, e.g., Zn, H2SO4, etc. If degradation did not find in any of above conditions. A few numbers of molecule designated rock stable molecules as these molecules didn’t degrade any of the above stress condition. During a stability study This kind of molecule will not engender any additional impurities/degradant peaks.

If drug substance or product shows stability for two years at 30 ±2⁰C & 65 ±5% RH & Six months at 40 ±2⁰C & 75 ±5%RH, then the drug substance or product declared stable.
Concentration of the drug that is being tested for the degradation is a great point. For the degradation study 1 mg/ml of drug concentration is recommended though some degradation studies are done at concentration of drug in the final product. Main cause for this type of study is that precise amount of the degradation can be found in final product & their impact can be scrutinized.

Factors Affecting Forced Degradation Studies

Go to top

Hydrolytic Degradation:

The reaction of chemical with water at different pH values occur in Hydrolysis degradation. In this degradation drug react with water in acidic & basic conditions. According to the stability of the drug substance concentration of the acid or base is selected where pH is 0.1 to 1.0 M HCl [Hydrochloric Acid] or H2SO4[Sulfuric Acid].

HCl & H2SO4 is used to maintain acidic conditions and 0.1 to 1.0M NaOH [Sodium hydroxide] or KOH [Potassium Hydroxide] used to generate basic conditions. Some materials are not readily dissolve/soluble in water freely; in that case other solvent are use to dissolve the water insoluble materials. Solvent shall be selected carefully so that it can’t degrade the selected drug substance.

Descriptive term	Part of the solvent require per part of solute
Very soluble	Less than 1
Free Soluble	From 1 to 10
Soluble	From 10 to 30
Sparingly soluble	From 30 to 100
Slightly soluble	From 100 to 1000
Very Slightly soluble	From 1000 to 10,000
Practically insoluble	10,000 and over

Reference: British Pharmacopoeia [BP]

Generally Chemical degradation shall be conduct in room temperature but if no sign of Chemical degradation occur at room temperature then room temperature shall be increase up to 50-60 ⁰C. A seven days timeframe shall be selected to perform the study. To prevent further degradation, Chemical degradation should be terminated using acid, base or buffer solution. Chemical analysis shall be done as soon as possible after completion of the test.

Oxidation Degradation:

in the forced degradation study, H2O2 (Hydrogen peroxide) is a widely used oxidizing agent. Hydrogen peroxide at 0.1% to3.0% solution is used at room temperature for 7 days is the suitable range to perform the activities. When more then20% degradation occur for a certain product, it can be considered abnormal cases.

Photolytic Degradation:

To determine the effect of light on the product during storage in the market Photostability testing of any drug take into consideration. light conditions shall be described during photostability. light source shall be cool white fluorescent lamp & wavelength of light shall be 200-800 nm (UV+ visible) which is also comply ICH guideline. The and the light intensity shall be not less than 200 watt-hours per sq meter and exposure time shall be not less than 1.2 million lux hours. To monitor the condition, a calibrated lux meter shall be use in place.

Result of forced degradation studies

[][]Forced degradation studies help to determine_
[][]Likely/Probable degradants
[][]Degradation paths
[][]Inherent stability of the drug molecule
[][]Validated stability indicating analytical method

When forced degradation studies to be performed?

Go to top

This is the best practice to perform forced degradation studies at the time of development of new drug substance and new drug product. FDA prefer to perform it at phase III of the regulatory submission which is the best time to do the same. To establish the regular stability study, forced degradation studies can be prerequisite. This study can be done in different pH solution in the presence of light & Oxygen with high temperature & Humidity Level.

Generally, degradation study performs on single batch. There are two types of timeframes are use to perform stability study which Long Term [12 Months] & Short Term [6 Months]. 6 Months are performed at accelerated condition. Moreover, Intermediate Stability Study performed in a condition lesser than accelerated condition.

Force degradation studies are performed at pre-clinical phase or phase I of clinical trial so that sufficient time provides to identifying structure elucidation, degradation products. If forced degradation studies are performed properly, manufacturing process of the new product can be developed properly and stability-indicating analytical procedures can be select more effectively.

What is the regulatory obligation regarding Force Degradation Studies?

Following ICH [International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use] Guidelines has been depicted regarding forced degradation studies but it covers only marketing applications for new products but not for during clinical development.

[][]ICH Q1A: Stability Testing of New Drug Substances and Products.
[][]ICH Q1B: Photo stability Testing of New Drug Substances and Products.
[][]ICH Q2B: Validation of Analytical Procedures: Methodology.

Go to top

What actually says this guideline?

[][]ICH Q1A (Stress testing): Stability Testing of New Drug Substances and Products.

It implies for the performing of forced degradation studies for drug substances and drug products. The recommended condition is that the result shall be observe temperature above accelerated condition [Temperature>500C) and Humidity [75% relative humidity] including oxidation and photolysis. pH range may be wide for the testing of solution or suspension.

[][]ICH Q1B: Photo stability Testing of New Drug Substances and Products.

It implies the photo stability of drug substances and drug products. Section II and Section III describe the forced degradation conditions condition for drug substance and drug product. Exposure levels are not defined in Forced degradation studies. Photo stability testing can be performed both in Solid or in solution/suspension. Stability indicating method is developed based on this sample result. Some non-experiential degradation products may be formed during stability studies which may not be taken under consideration.

[][]ICH Q2B: Validation of Analytical Procedures: Methodology.

Provide guideline regarding analytical meth validation. Gives guidance to validate the analytical methodology. To demonstrate specificity, in section B1.2.2 (impurities not available) there is a recommendation to utilize samples from the forced degradation studies.

Verdict

to develop degradation pathways, Forced degradation studies are the prominent way & Forced degradation studies are the prominent way to develop degradation pathways and to detect degradation products of API [Active pharmaceutical Ingredients], further it simplifies elucidation of degradants structure. Forced degradation studies also simplify the chemical & physical stability analysis of drug substances & drug products. To develop manufacturing conditions, storage conditions & determine expiry date of a new drug formulation Forced degradation studies is considered as key studies.

Forced Degradation Study or Stress Testing Procedure Read More »

Comparative Dissolution Study procedure

Pharma Operations, Protocol, Quality Assurance, Quality Control

Comparative Dissolution, General Overview

[][]Comparative Dissolution, Oral dosage form like Table & Capsule are more popular than IV/IM(Intravenous/Intramuscular) Injection formulation. From the very beginning, people are most familiar with oral solid dosage form (Tablet, Capsule, Powder etc.) and becoming more popular till today as no special technique or device is not require to administer these products and associated pain is not involved here.

[][]In the period of time its are considered as the most effective and efficient method to treat the patient. This orally taken drugs are dissolved in GI (Gastro Intestinal) fluid and then bioavailable at the systemic circulation as it absorbed here. To measure the bioavailability of a certain drugs (in vivo Analysis, vivo is Latin for “within the living, test perform in living organism) is not accurately possible due to its complex nature.

[][]For this reason, in vitro (vitro is Latin for “within the glass, test perform outside the living organism) methods are followed to measure the dissolution rate of a certain drugs. This method is officially recognized by certain regulatory authority and it(in vitro study) considered most convenient way to develop new formulation of oral solid dosage form.

Comparative Dissolution Consideration

[][]Dissolution method is the best option for the lower strength drug where different strength is proportionally formulated to acquire the biowaiver of certain formulated drug. For a certain product which higher strength bioequivalence study has been carried out and found proportional to the concentration then biowaiver is conceivable to the lower strength.

[][]The most physiological factor is considered as the dissolution and solubility of the API and its permeability through the membrane of the GI[Gastro Intestinal] tract. As this measurement is so prone to error due to its complex nature then in vitro study consider the most convenient and reliable procedure to achieve the required target. During development of a certain solid dosage form, dissolution is considered as the best option to determine its quality parameter which have the great impact on the bioavailability of the formulated product.

Comparative Dissolution, Waiver of in vivo bioavailability

[][]BCS system applied in this case so that waiver for in vivo analysis can be assured. BCS [Biopharmaceutical Classification System] is a system which measure the permeability and solubility of drugs in a certain prescribed condition.

[][]The actual aim of BCS is to aid the post approval changes and arranging approval activities based on in vitro data studies.

Go to top

This system has been optimized based on the oral solid dosage unit as most of the market products are available at oral dosage form [More than 50% total market share, US$23.4 Bn in 2021, US$24.7 Bn in 2022 as estimated, growth rate 5.9%).

[][]Waivers[ means giving permission to skip in vivo bioequivalence study] is actually reserved for those products that meet the specific requirements of solubility & permeability & most of the cases rapid dissolve in body fluid.

[][]Using the BCS, appropriate formulation study shall be developed such as Type II drugs designed as Permeable but insoluble, this class is not the actual right candidate for development of a new moiety.

[][]So, solubility shall be developed to acquire the right dissolution profile. Based on the solubility and permeability BCS has classified the four categories of the product as depicted below

Dosage form challenge

[][]Comparison has been drawn from old drug to new drug formulation, where older drugs compare to the current products are more prone to solubilities. Class II compound has been remarkably increased as 30% to 60% where class I compound has down to 40% to 20% where low solubility has the main cause to encounter the issue.

A oral solid dosage form is the preferred option but all time this can’t possible the suspension or solution is continued to prove its existence

[][]Generally a highly soluble active substance and rapidly dissolve dosage form provide better bioavailability and in this case biowaiver can be waived for bioequivalence studies base on its dissolution profile.

[][]If a active substance found low solubility but high permeability then the rate limiting steps of absorption may be consider as dissolution. Most of the cases dissolution profile control the more than one of excipients or special design matrix compounds. So Test condition may be consider as various time frame (10, 15, 20,30, 45 & 6 minutes).

[][]Drugs that are poor soluble in water then various time frame are considered and accepted timeframe is set for dissolution profile. Here USP Type 4 apparatus to be used to develop such type dissolution profile. Most of the time, monograph for combination product is not available at BP or USP the individual monograph shall be used to set the dissolution profile.

Selection of Dissolution Media

Selection of the dissolution media is the vital point to achieve the goal. pH of the media as the key role as all of the dosage form goes to GI[Gastro Intestinal] tract so pH shall be simulate with the GI Tract environment. pH shall be 1.2 to 6.8 which is the physiologic pH range of the body.

Zone	pH
[A]Pre-prandial Stomach	1.8(1~3)
Duodenum	6.0(4~7)
Upper Jejunum	6.5(5.5~7)
Lower Jejunum	6.8(6~7.2)
Upper Ileum	7.2(6.5~7.5)
Lower Ileum	7.5(7~8)
Proximal Colon	(5.5 ~6.5)

[B]Post-prandial Stomach	4.0(3~6)
Duodenum	5.0(4~7)
Upper Jejunum	5.5(5.5~7)
Lower Jejunum	6.5(6~7.2)
Upper Ileum	7.2(6.5~7.5)
Lower Ileum	7.5(7~8)
Proximal Colon	(5.5 ~6.5)

Dissolution Statistics

Different cases obtaining after multipoint dissolution which is calculative as follows:
[][]If Test Product and Reference Product both shows dissolution rate more than 85% within first 15 minutes then no calculation is required, they are considered as similar. If it didn’t achieved then seek for next step.
[][]Seek for f2 value[ f2, similarity factor] if f2>50% then it consider similar then in vivo study is not required.
[][]Difference Factor [f1] is the percentage (%) difference between the two curve at the each time period and also measure the relative error between two curve.

How it works

To determine the difference and similarity factor(f2) following pont shall be noted:
[][]Use the Two different products for study, from each product collect 12 unit [12 unit from Test Product & 12 Unit from Reference Product].

[][]Three time point shall be considered[Exclude Point Zero], only one measurement after 85% shall be measured.
[][]Produced curve shall be similar, f2 values shall be close to 100. Most of the time f2 value more than 50 denote similarity of the two curves as well as equivalence of the two products.

If Three/Four Time points come to the test then following points shall be considered.

[][]The measurement for the Test Product and the Reference product shall be same. Dissolution Time point shall be same for the both product (10,15,20,30,45,60 minutes etc.). Products which tend to faster dissolution (85% dissolve within 30 minutes) then time frame shall be consider as 10, 15, 20, 30 minutes.
[][]Only One measurement shall be consider after completion of 85% dissolution of both sample and reference products.

System Requirements to Perform Comparative Dissolution

Dissolution Activities shall be continued on USP Type I Dissolution apparatus at 100 RPM or USP Type II Apparatus at 50 RPM using 900 ml of different dissolution media mentioned below.
[][]Media Use in Comparative Dissolution
[][]Acid Media: 0.1N HCL or Simulated Gastric Fluid USP without Enzyme
[][]Acetate Buffer pH 4.5
[][]Phosphate Buffer pH 6.8 or Simulated Intestinal Fluid without Enzyme
[][]If both the Test Product and Reference product shows more than 85% dissolution within first 15 minutes then no calculation required. If not meets the above requirements then calculate f2 Value.
[][]If found f2>50, then the profile considered as similar and in vivo study is not required. Minimum 12 unit of each shall be consider for comparative dissolution.

Download Here

Comparative Dissolution Study Protocol

Comparative Dissolution Study procedure Read More »

Performance Qualification of WFI Phase 3

Performance Qualification Protocol, Pharma Operations, Protocol

Performance Qualification of WFI, Purpose

Performance Qualification of WFI, To authenticate and document that the performance of the WFI Generation and Distribution System installed at the WFI & PS plant room (roof top) of Cephalosporin Block of XX Pharmaceuticals Limited is satisfactory in all critical features related to the operational requirements during Phase – 3 study.

Performance Qualification of WFI, Scope

This protocol will be applicable for performing Phase – 3 validation study to verify that the Water For Injection generation and distribution system installed at WFI & PS plant room (roof top) of Cephalosporin Block of XX Pharmaceuticals Limited consistently produce desired quality of Water For Injection over the study period of 01 year.

People also Read

Water For Injection Performance Qualification of Phase 2 Study

Responsibilities

[][]Preparation of the protocol
Validation (Engineering) Department.
[][]Executing the protocol
Validation team along with respective departmental person and engineers or other suitably qualified staff allocated from the site or contracted specialists as appropriate.
[][]Chemical test
Quality Control Department
[][]Microbiological Test
Microbiology Department
[][]Data documentation and preparation of the report
Validation (Engineering) department.
[][]Verifying the report
Concerned departmental person.
[][]Providing documentation on the equipment
Related departments i.e. Engineering, Quality Control, Microbiology, Validation.

System And Process Description

System Information

=>Manufacturer : Watertown
=>Capacity : 750 ltr/hr
=>Model : MS750/4T
=>Manufacturer no. : MS1132

The System under test

[][]The Water For Injection system is designed to generate and distribute the desired quantity & quality of Water For Injection to various user points.

Generation system of Water For Injection

[][]The WFI production process consists of purified water evaporation followed by pure steam separation and condensation through four multi-effect water still columns.

[][]Purified water from the storage tank is pressurized through a feed water pump and pre heated in the four pre heaters.

[][]Then, the purified water becomes pure steam in the four multi effect columns by exchanging heat with the plant steam.

[][]There are two condensers in the system. The first condenser is used to cool the pure steam by exchanging heat with the incoming feed water (PW).

[][]Finally, the WFI is produced in second condenser by exchanging heat with the chilled water which is then supplied to the WFI storage tank.

Distribution system of Water For Injection

[][]The WFI is stored in a WFI storage tank of 2000 ltr capacity and is distributed to the user points and circulated within a loop by a high pressure pump.

[][]There is a heat exchanger in the distribution section to sterilize the whole distribution system.

Tests To Be Performed And Sampling Plan

[][]A comprehensive validation study plan has been established where a weekly sampling plan has been developed for Phase-3 study of WFI system for 01 year concerning weekly testing of all main sampling points.

[][]The sampling will be taken one day a week on working days. The acceptance criterion of the tests are stated in the table.

Main Sampling Points

The sampling points of WFI are listed below:

Sl. No.	Sample ID	User point Location	Tests	Microbial Count/ Chemical Tests
01	WSP-1	Final WFI after condenser – 2 (before WFI storage tank).	Next Table	Weekly
02	WSP-2	At supply of WFI Distribution Loop	Next Table	Weekly
03	WSP-3	At return of WFI Distribution Loop	Next Table	Weekly
04	WUSP – 01	WFI Distribution Loop	Next Table	Weekly
05	WUSP – 02	WFI Distribution Loop	Next Table	Weekly
06	WUSP – 03	WFI Distribution Loop	Next Table	Weekly
07	WUSP – 04	Cold User point	Next Table	Weekly

Tests and Acceptance Criteria for Water for Injection

Sl. No.	Tests	Frequency	Acceptance Criteria	Alert Limit	Action Limit
01	Appearance	Daily from each sampling point.	Clear, colorless and odorless liquid.	N/A	N/A
02	Conductivity	Daily from each sampling point.	Not more than 1.1 µS/cm at 20⁰C or Not more than 1.3 µS/cm at 25⁰C	0.7 µS/cm	0.9 µS/cm
03	Total Organic Carbon	Daily from each sampling point.	Not more than 500 ppb	106.4 ppb	135.8 ppb
04	Total Viable Microbial Count	Daily from each sampling point.	Not more than 10 CFU/100 mL	5 CFU/100 mL	8 CFU/100 mL
05	E.coli	Daily from each sampling point.	Must be Absent	N/A	N/A
06	Staphylococcus aureus	Daily from each sampling point.	Must be Absent	N/A	N/A
07	Pseudomonas aeruginosa	Daily from each sampling point.	Must be Absent	N/A	N/A
08	Salmonella spp	Daily from each sampling point.	Must be Absent	N/A	N/A
09	Bacterial Endotoxins	Daily from each sampling point.	Less than 0.25 EU /mL	N/A	N/A

[][]Performance Qualification shall be considered acceptable when all the conditions above have been met.
[][]Any deviation from the acceptance criteria of the specific check point shall be reported and decision should be taken for the rejection, replacement or rectification of the equipment/component/system.

Conclusion

[][]The results of the Phase – 3 study, as per the qualification protocol are recorded & analyzed.

[][]The observed parameters/tests and subsequent analytical results show that the Water For Injection Generation and Distribution System Complies/Does Not Comply as per the predetermined acceptance criteria.
[][]Hence, the Water For Injection Generation and Distribution is / is not qualifying the Phase – 3 study of Performance Qualification and the System can be / cannot be used for production purpose and continued to regular monitoring by Quality Control and Microbiology department.

Download Here

Performance Qualification Protocol of WFI Phase 3

Performance Qualification of WFI Phase 3 Read More »