Qualified Person (QP)
Qualified Person (QP), is mainly responsible to confirming/assuring the quality of certain batch of pharmaceuticals products. So this is very important that a Qualified Person (QP) must be in depth understanding of the pharmaceutical manufacturing, quality control and overall activities of the marketed products.
Qualified Person (QP), is the responsible person to certify a certain batch of pharmaceutical product prior to use for trail purpose or to send in the distribution channel for marketing.
This is not mandatory to understanding the manufacturing practice/process/procedure accurately but he must be understand the critical factors which may affect the critical quality parameters, safety and distribution/supply chain of the marketed products.
Qualified Person working area:
Most of the Qualified Person[QP] working in different pharmaceutical companies in various role mainly in product releasing activities but they also involve in national health sector, in such type of departments which hold different manufacturer authorisation to create various medicinal products mainly use in investigational purpose.
How do I become a Qualified Person?
1.0 Find a sponsor
A sponsor to be find out regarding individual guidance, training, prepare for final assessment, sponsor reporting about your eligibility to act as a Qualified Person[QP]. The sponsor also verify your application form signature required in various section of the application form.
Eligibility of Sponsor:
The sponsor must be the member one of the three professional body [The Royal Pharmaceutical Society, the Royal Society of Biology and Royal Society of Chemistry] and he must a QP [Qualified Person]. If your sponsor fail to meet criteria, then the sponsors form must be countersigned by the QP [Qualified Person] who will responsible to acting this issue about your engagement.
The sponsor must be involve in practicing QP who is known to you and he professionally known you in qualified period experience[1 year for Pharmacist and 2 Years for other professionals]. If you didn’t manage it, then you can use a Quality Assurance Line manager provided the report and countersigned by a QP.
Your sponsor is projected to:
Confirm that you have the sufficient knowledge of the subject that covered by the study guide. Certify the adequate experience.
A sponsor is actually a mentor for you. He will help you regarding your preparedness of the assessment, he will guide you to attain your success. He will confirm you that you possess the sufficient knowledge for final assessment. He will trained you in every step for apply the final assessment. Your Sponsor will provide you the necessary study guide and confirm that you possess the essential knowledge, skill, experience and personal attribute to act as QP[Qualified Person] at actual.
Role of an active sponsor
Role of the sponsor is the key to success of the applicant. This is very important for the applicant to find out an active sponsor because a sponsor is always involve the applicant training and application process. A sponsorship is always appreciated if role and responsibilities perform on great care. Regular interaction with the applicant is very important and this activity will be consider as mentor.
The sponsor Form and the application form is the first step of assessment process due to these two forms provide the documented evidence regarding employee background. The well documented application provide the positive impression to the Assessors.
The sponsor must have the experience and knowledge about pharmaceutical manufacturing, Quality Assurance and GMP[Good Manufacturing Practice]. Well conversant and up to date of the legal framework of EU and UK. Better understanding and relationship with professional bodies of MHRA & VMD [Medicine and Healthcare products Regulatory Agency & Veterinary Medicines Directorate].
The code of practice, role and responsibility of QP to be known including Study Guide and practical experience requirements. It is top most priority to be well familiar with the pharmaceutical business especially in Research and Development, production, Quality, Marketing and distribution.
An active Sponsor must possess good inter-personal skills and well communicator, having good contacts outside the company will add extra benefit. A better Sponsor will work as mentor who will provide the guidance to the aspiring applicant including positive direction.
Regular interaction is the key factor of the success, sponsor may communicate with applicant via various type of communication method [FB Messenger, WhatsApp,SMS,Emailing etc.] if unable to direct contact. Sponsor should monitor the daily activities of the applicant and prepare a progress report.
Sponsor’s report
Before submitting the application a sponsor form must be submit with the application. An application will not accept/review without sponsor report. A sponsor report must be different from applicant, sponsor report may not represent the same as applicant form.
A honest review is always create positive impression to the applicant. A sponsor report well be well described about the candidate. Every single details will be mention here. Applicant strong side as well as weak side, strength, personal attribute, development field need to mention very clearly.
The report is a key part of the sponsor’s input and it is not sufficient for you to simply provide a declaration of belief that an applicant complies with the requirements. It should be a critical and honest evaluation of the applicant’s technical and professional knowledge. It should also include information on the applicant’s personal attributes, including his or her strengths and weaknesses or areas for development.
A sponsor may indicate the following criteria of the Applicant but not limited to-
- Attitude
- Communications skill
- Extracurricular activities
- Flexibility
- Hobbies
- Open Mindedness
- Organizational behavior
- Peer coworker relationships
- Planning and organizing skill
- Professional integrity and ethics
- Problem solving capacity
- Verbal skill
- Reliability
- Working under pressure
This very important to notify the every single points on the report. Application primary assessment may be late based on the points and further clarification may be asked. Sponsor need to confirm that the applicant has gained the proper knowledge and experience in the Manufacturer’s Authorization and Manufacturer’s Authorization number with issue date to be mention with the application. A sponsor must declare the direct the working experience with the applicant. Different report will claim for multiple establishment.
2. Gain relevant experience
To be a QP[Qualified Person], a person shall be possess a certificate, diploma, or other evidence which can prove his formal qualification evidence which achieved after completion of University course, covering a duration at least Four Years of theoretical and practical studies one of the listed scientific discipline:
- Chemistry
- Medicine
- Pharmacy
- Pharmaceutical chemistry
- Pharmaceutical technology
- Pharmaceutical biology
- Veterinary medicine
The minimum duration of the university course may be three and half year, where the course followed the theoretical and practical training duration minimum one year and training period will be six month in a pharmacy open to public collaborated by examination at university level will be preferred.
When two university course declared equivalent and one course extend to Four years but other course extend to three years then the three years course will be treat as diploma, the course shall include the listed basic subjects at least:
- Analytical chemistry
- Experimental physics
- General and inorganic chemistry
- General and applied biochemistry (medical)
- Microbiology
- Organic chemistry
- Pharmaceutical chemistry
- Pharmacognosy
- Physiology
- Pharmacology
- Pharmaceutical technology
- Toxicology
The QP[Qualified Person] experienced in practical required two years in authorized manufactures and experienced may be reduced to One Year where the university course extending to Five years.
Overall, at least Two years expected is required in one or multiple facility which produce medicinal products but if you are pharmacist, you need only one year.
3. Apply through your professional body
The eligibility of QP, he must be the Pharmaceutical Scientist or Associate or Fellow or member of RPS[ Royal Pharmaceutical Society] who has qualified on the basis of formal course of study lasting not less than three years in fulltime or equivalent.
Minimum One year of practical experience is required for pharmacist, if anyone want to apply for QP eligibility but not registered a as pharmacist recommended to contact with QP officer for advice prior to apply.
If your Sponsor is satisfied that you are ready to apply then submit the application form with required fee [£700, may be change anytime], sponsors report and countersigned copy of your own certificates.
4. Wait for your initial assessment
If you application fulfill the requirement then QP officer will confirm you that your application has been received. Your application will be assessed be the designated assessor if the result goet to positive then you will be invited for interview session.
5.0 Attend your interview
Your interview will be held on London physically if situation is normal. Sometime virtual interview may held based on situation, QP officer will confirm you about this issue. If you passed the interview then you will be listed as QP person at your professional body.
Role and responsibility of QP
All of the pharmaceutical manufacturing authority and regulatory body ensure that the end user [Patients] are safe and the medicinal products meets its predetermined specification for sale or supply and confirm the basic requirements for safety, quality and efficacy.
- In a pharmaceutical company a QP plays a vital role certifying the batch confirms the predetermined specifications and its can be released for sale or supply or trial.
- QP is responsible to confirm that each manufactured batch has been checked in compliance with the laws in specific certifying authority.
- QP role and responsibility irrespective where the product will be sale/distributed/used.
- QP to be understand the demand of specific Authorization and confirm that PQS[Pharmaceutical Quality System] in place and satisfactory for the purpose.
- QP must understand the relevant steps of pharmaceutical manufacturing steps before certifying the specific batch.
- Must be full understanding of EU GMP guideline.
- QP must have decline to certify the specific products which process and procedure is unknown to him.
Career prospects of QP
The Career is widely distributed for the QP in various types of pharmaceutical industry as well as other designated industries who are involving in manufacturing of healthcare related products undergo to regulatory bindings. In pharmaceutical industry a QP can work in production, marketing, quality control, product development, quality assurance, project management etc. areas.
Resources to become QP and formal application process
Application form
Guidance notes for applicants and sponsors
Study Guide
Code of Practice for Qualified Persons
Sponsor Form
Download all Resource Here: