SOPs

Manufacturing & Expiration Date, Purpose :

Manufacturing & Expiration Date, The purpose of this SOP (Standard Operating Procedure) is to provide a system for assigning of manufacturing & expiration date of products manufactured in XX Pharmaceuticals Limited.

Manufacturing & Expiration Date, Scope :

All departments of XX Pharmaceuticals Limited (Both General and Sterile Block).

Definitions/Abbreviation:

[][]BMR : Batch Manufacturing Record
[][]BPR : Batch Packaging Record
[][]LPL : XX Pharmaceuticals Limited
[][]MFG. : Manufacturing Date
[][]EXP. : Expiry Date
[][]VAT : Value Added Tax
[][]IP : Indicating Price

Responsibilities:

[][]The roles and responsibility is as follows:

Executive, Quality Assurance

[][]To ensure that this procedure is followed.

Executive, Production

[][]To follow laid down procedure.

Manager, Quality Assurance

[][]To ensure implementation of the SOP.

Head of Quality Assurance

[][]Approval of the SOP.

Annexure:

N/A

Procedure:

Assigning of Manufacturing Date
[][]Determine the manufacturing date of a batch from the month and year at which manufacturing of that batch starts (i.e. dispensing). Consider the BMR issue date as starting point of a batch. So the month and year of issuing BMR will consider as manufacturing date.
[][]First 3 (three) letters of month and last 2 (two) numerical digits of year representing the manufacturing date.
[][]Assign the manufacturing date in block letters.
Assigning of Expiry Date
[][]Determine the expiry date from the manufacturing date and claimed shelf life of the product.
[][]First 3 (three) letters of month and last 2 (two) numerical digits of year representing the expiration date.

[][]Those products which have no manufacturing steps except encapsulation / filling, expiry date will be declared as the manufacturer’s claimed expiry date of the active material (i.e. pellets, ready granules, different materials for injectable etc.).
[][]When the active material of two different Lab. Control No. will use in one batch, then the expiry date of the product should be considered as like shorter expiry date of API claimed by the manufacturer.
[][]Assign the expiry date in block letters.
Example: a) When claimed shelf life is 1 years.
[][]For example: Cerolab 10 Tablet
[][]If manufacturing starts (or BMR issue) at January .
[][]The manufacturing date is JAN  and expiry date is DEC of the following year
b) When claimed shelf life is 1.5 (One and half) years.
[][]For example: Cerporal PFS, 50 ml
[][]If manufacturing starts (or BMR issue) at January
[][]The manufacturing date is JAN  and the expiry date is JUN of the following year

[][]Batch number, manufacturing date, expiry date and indicating price should be printed in different packaging material as following procedure:
For inner carton (if product shelf life is 1 year)
BATCH NO. : XX0001
MFG. DATE : JAN XX
EXP. DATE : DEC XX
IP (with VAT) :

Qualification ,Purpose :

Qualification , The purpose of this SOP (Standard Operating Procedure) is to provide guidelines for carrying out the qualification at the site.

Qualification , Scope :

This SOP is applicable for qualification of all equipment, instrument, facility and utility at the site of General Block and Sterile Block of XX Pharmaceutical Ltd.

Definitions / Abbreviation:

[][]Qualification: The action of proving and documenting that equipment or utility are properly installed, work correctly, and actually produce the expected results.
[][]User Requirement Specification (URS): Documented requirement of the equipment, utility for its intended purpose. Functional design and specification according to cGMP and regulatory requirements.
[][]Design Qualification (DQ): Documented verification that the proposed design of the equipment, utility is suitable for the intended purpose.
[][]Installation Qualification (IQ): Documented verification that the equipment, utility as installed or modified, comply with the approved design, manufacturer’s recommendations and user requirement. FAT& SAT to be added.
[][]Performance Qualification (PQ): Documented verification that the equipment, utility is performing effectively and reproducibly, based on approved method and specifications.
[][]Factory Acceptance Test (FAT): Documented verification of the equipment at vendor’s site against approved design.
[][]Site Acceptable Test (SAT): Documented verification of the equipment at user site against approved design.
[][]HVAC: Heating, Ventilation & Air Conditioning
[][]LAF: Laminar Air Flow

Responsibilities:

[][]The roles and responsibility is as follows:

User department

[][]To prepare the URS of equipments, instruments, facility, utility.
[][]To prepare DQ (if required).
[][]To prepare PQ protocols

Validation Team

[][]He I She shall be responsible to carry out this procedure as defined

Engineering Department

[][]To prepare IQ, OQ protocols whenever required.
[][]To provide technical assistance to the user department for preparation of require documents.
[][]To prepare protocols for facility and utility in co- ordination with user department

Quality Assurance

[][]To review protocols and to provide technical inputs
[][]To review  reports for its completeness and correctness all data and report.

Head of Engineering

[][]He I She shall Be Responsible for Effective Implementation of this Procedure.

Head of Plant

[][]He I She shall Be Responsible for Effective Implementation of this procedure.

Head of Quality Assurance

[][]He/ She shall be responsible for effective implementation of this procedure.
[][]To approve protocols, reports and master plan.
[][]Approval of the SOP.

External agency

To provide technical assistance for preparation of documents and execution of activities whenever required

Procedure:

Methodology

[][]Facilities, Utilities and Equipment’s used for manufacturing, processing, packaging, labeling, storing, testing and controlling of drug products shall be qualified prior to use.
[][] It shall be performed for new equipment /instruments/utility/facility, after major breakdown in equipment/utility, after modification in equipment/instrument/utility and facility.
[][]Re-qualification shall be performed at define frequency.

Introduction of a new equipment/ facility/ utility:

[][]After receiving the new Equipment Engineering shall make entry in respective format and Concern
[][]department shall update the Equipment Master List as per respective of SOP.
[][]Equipment no. shall be assigned as per the SOP for Equipment and Instrument Numbering System.
[][]For new equipment following activities shall be done to demonstrate conformance to design documents, characteristics, and capabilities specified in required documents.
[][]User requirement specification (URS)
[][]Design qualification(DQ)
[][]Factory Acceptance Tests (FAT)
[][]Site Acceptance Test (SAT)
[][]Installation Qualification(IQ)
[][]Operation qualification(OQ)
[][]Performance Qualification(PQ)

User Requirement Specification:

[][]The URS is made to verify that the owner/user requirement, which includes establishment of critical operating or operational parameters or specifications before the final design agreed, has been met.
[][]User shall prepare the URS considering all operational, safety and GMP requirements.
[][]The user requirement shall be submitted to manufacturer/supplier, based on which manufacturer/supplier will prepare design.

DQ:

[][]The DQ is made to verify that the owner/user requirement, which include establishment of critical operating or operational parameters or specifications before the final design is agreed, has been met.
[][]Based on URS, manufacturer/supplier shall prepare design it documents and submit to user for approval.
[][]On the basis of approved design it documents, manufacturer /supplier shall start manufacturing/fabricating the equipment/utility.

Factory Acceptance Test:

[][]The FAT is prepared to verify that the main items or system meets design specification and conforms to agreed performance intent.
[][]User shall prepare FAT protocol according to URS/DQ, manufacturer specification and purchase order User shall ensure that the equipment/system is manufactured as per designed specification at manufacturer’s site.
[][]User also check the basic performance of the equipment/ system delivered at plant meets the design specification.
[][]User shall take photocopy of the approved FAT protocol and execute at the manufacturer’s site with QA and Engineering representative.
[][]All the test shall be performed and reported by the supplier. All tests performed during FAT must be performed in accordance with reviewed and and approved protocol and procedure.

Site Acceptance Test:

[][]The SAT is to establish documented evidence that the receipt of the item at site confirms with the standards laid down in the protocol, FAT, purchase order and manufacturer’s specification.
[][]User shall prepare SAT protocol according to the manufacturer specification, purchase order and FAT report.
[][]User shall take photocopy of the approved SAT protocol and will check the entire test mentioned in protocol with the QA & Engineering representative at the site when item I equipment I system reaches to the factory premises and reported by the production and engineer.

Installation Qualification:

[][]Installation Qualification of Equipment/utility shall be carried out is to ensure that the equipment I utility is installed according to design documents, purchase. Specifications, FAT and SAT report and planned modification.
[][]The parts of the systems, which are disassembled prior to shipping, shall be noted and be verified again after re-assembly at the final site during IQ.
[][]Equipment/utility shall be inspected either visually or by measurement for its critical parts. Wherever applicable other instruments shall be used for this purpose.
[][]All the relevant tests mentioned in protocol shall be checked after proper installation of equipment. Calibration of instrument attached with equipment and other related shall carried out before starting OQ.
[][]After completion of IQ the equipment shall be released OQ.

Operation Qualification:

[][]The Operational Qualification is carried out to verify that an Equipment/system or subsystem performs as intended throughout all anticipated operating ranges.
[][]Operation qualification activities shall start only after completion of successful IQ.
[][]QA and User representative shall use photocopy of approved protocol, which is used earlier during IQ.
[][]User department shall verify proper operation by performing the critical operating parameters that have significant impact on the equipment ability to operate and meet specifications satisfactory.
[][]User department shall prepared final conclusion after the test functions are checked and observed within specification.
[][]After completion of OQ the equipment shall be released either for PQ or for routine use as the case may be.

Performance Qualification:

[][]The performance qualification is carried out to provide documented evidence that an integrated system or processing operation is capable of performing consistently (during multiple cycles or extended periods) to give an outcome that meets predetermined specifications.
[][]PQ activities shall start only after completion of successful OQ.
[][]PQ of equipment depends upon equipment intended use and its operation.
[][]Data shall be generated to establish that the equipment meets the requirement as expected of it.
[][]A final report shall be prepared, summarizing the results obtained, commenting on any deviation observed and final conclusion shall be given after the PQ.
[][]PQ can be performed on commercial batches for new equipment. The batches shall be released only after the qualification of the equipment is completed or can be performed on placebo /dummy / trials wherever applicable.
[][]PQ shall be performed for consecutive three batches/trials with load.
[][]After completion of execution, all raw data and reports shall be compiled and a final conclusion shall be drawn.
[][]After final approval of conclusion/report by plant head and quality head the respective equipment, instrument, facility and utility shall be allowed for routine use.

Note: Operation and PQ shall be carried only if desired utility is available and environmental conditions (wherever applicable) are achieved in the area.
Qualification for introduction of a new Instrument:

[][]For new Instrument following activities shall be done to demonstrate conformance to design documents, characteristics, and capabilities specified in requirements documents.
=>Installation Qualification (IQ)
=>Operation qualification (OQ)
=>Performance Qualification (PQ)

[][]IQ : for new Instrument shall be carried out as per procedure mention above.
[][]OQ : OQ for new Instrument shall be carried out as per procedure mention above.
[][]PQ : OQ for new Instrument shall be carried out as per procedure mention above.

Protocol Preparation for FAT, SAT, IQ, OQ and PQ:

[][]The protocol for Qualification (FAT/SAT/ IQ / OQ / PQ) shall address and include, but not necessarily be limited, to the following topics.
[][]FAT: Approval, purpose, procedure, verification criteria, Manufacturer’s Machine Identification Code / Identification No., Final report approval.
[][]SAT: Approval, purpose, procedure, Documentation, Verification criteria, Final report approval.
[][]IQ/OQ/PQ: Purpose, Scope, Responsibility, Intended Use, Location, Reference, History, Attachments, Study for qualification, Responsibilities, Signature log, Training record.
[][]IQ : Equipment/Instrument Detail, Procedure, IQ table, Conclusion.
[][]OQ : SOP training, Procedure, OQ table, Observed deviation, Conclusion.
[][]PQ: Procedure, Acceptance criteria, Observed deviation, Final Conclusion Report approval sheet.
[][]Specimen of Header and Footer for above protocol is as per given below.

At the Header Section

1st Column: Company Logo
2nd Column: Company Name, Address Details
3rd Column: Doc. Title, Document No., & Location

Specimen of Footer on all Page

CONFIDENTIAL TECHNICAL DOCUMENT

[][]Numbering and Issuance system for Qualification protocol shall be as per SOP for Document numbering system.

Area Qualification:

[][]Area Qualification is carried out to provide the documentary evidences that particular area is constructed and qualified as per predefined specification.
[][]Below mentioned activities shall be performed during execution of Area Qualification, but not limited to.
[][]Construction and finishing of wall, floor, doors, view panels and ceiling.
[][]Dimension measurement wherever applicable.
[][]All the required utilities and other facilities supplied.

[][]Lighting lux of every room in all four corners and center of the room.
[][]Temperature Mapping for Classified area.
[][]Environmental condition monitoring for classified area.
[][]Water drains ability of drains.
[][]Cleaning and Sanitization Procedure.
[][]User department shall prepare the qualification protocol and organize the qualification study in co- ordination with Quality Assurance and Engineering department.
[][]Protocol/Report shall be finally reviewed by Multidisciplinary authorized personnel along with QA personnel and approved by Quality Head.

[][]Specimen of Header and Footer for above protocol is as mentioned above.
[][]Numbering and Issuance system for Qualification protocol shall be as per SOP for Document numbering system.

Qualification of HVAC system:

[][]HVAC qualification shall be carried out to supply the required air quality to the various section of individual department to provide product protection from air borne contamination, to maintain the temperature and humidity, to provide differential room pressure or air flow movement to provide product protection from cross – contamination.
[][]All HVAC system like AHU’s shall be qualified as per procedure described above as per approved protocols.
[][]Engineering department shall prepare the qualification protocol and organize the qualification study in co-ordination with Quality Assurance.
[][]Engineering person shall record the observations as per designed protocol and prepare a report.
[][]Below mentioned test shall be performed during qualification of AHU, but not limited to.

DOP or PAO Test
Air velocity & Air changes Test
Non viable particle count
Filter efficiency & integrity.
Particle count Test.
Microbial Count.
Air Flow Direction & Air Flow Pattern
Recovery Study
Protocol/Report shall be finally reviewed by QA and approved by Head of QA.
Specimen of Header and Footer for above protocol is as mentioned above.

[][]Numbering and Issuance system for Qualification protocol shall be as per SOP for Document
numbering system.

Qualification of LAF:

[][]Qualification of LAF shall be carried out to provide the air with high-pressure compare to surrounding area and to prevent microbial and particulate matters contamination during dispensing/sampling of Raw material, prevent dusting during dispensing/Sampling.
[][]All LAF shall be qualified as per procedures described  as per approved protocol.
[][]User department shall prepared the qualification protocol and organize the qualification study in co-ordination with QA & Engineering department.
[][]Numbering and Issuance system for Qualification protocol shall be as per SOP for Document numbering system.

[][]Installation Qualification: IQ of LAF shall be carried out to check LAF size as per requirement, to check pre-filter, motor blower, Magnehelic gauge and final HEPA filter as per specification.
[][]Operational Qualification: OQ of LAF shall be carried out to run the LAF and to check the operational parameter functioning.
[][]Performance Qualification: PQ of LAF shall be carried out to check LAF air velocity, Air flow pattern, air cleanliness by non viable particle count and HEPA filter efficiency & integrity, etc.
[][]User department shall record the observations as per designed protocol and prepared a report.
[][]Protocol/Report shall be finally reviewed by QA and approved by Head of QA.

Qualification of Water System:

[][]Water system qualification shall be carried out to generate Potable water & purified water of desired quality.
[][]Engineering department shall prepared the qualification protocol and organize the qualification study in co-ordination with QA.
[][]Qualification protocol shall carried following details but not limited to, IQ: Equipment/instrument details, procedure, Acceptance criteria, Pre-
qualification, Installation check, summary & conclusion.
[][]OQ: Training, Procedure, Acceptance criteria, operating inputs, summary & conclusion.
[][]PQ: Study plan, sampling Frequency, user point, summary & report.
[][]PQ of water system shall be carried out in a two phase.
[][]In phase 1, water quality parameter trend shall be evaluated on monthly basis.
[][]In phase 2, water quality parameter trend shall be evaluated after one year to evaluate impact of seasonal changes on quality of water.
[][]Engineering department shall record the observations as per designed protocol and prepared a report.
[][]Protocol/Report shall be finally reviewed by QA and approved Head of QA.
[][]Numbering and Issuance system for Qualification protocol shall be as per SOP for Document numbering system.

Re-qualification strategy:

[][]Equipment futility shall be re-qualified either in following conditions:
[][]Major Break Down.
[][]After modification in equipment, utility, facility which may have an impact on product quality only.
[][]Design change of spares that have impact on the performance of equipment and quality of product.
[][]In case of during Location change of equipment. (In case of balances only recalibration shall be done).
[][]As per scheduled re-qualification of critical and non equipment/utility.
[][]OQ & PQ shall be performed during requalification.
[][]PQ shall be performed with one batch during requalification.

Re-qualification criteria for critical equipment:

[][]Operational and performance qualification shall be done as per approved protocol for re-qualification of critical equipment.
[][]All critical equipments shall be re-qualified after every three years ± 1 month.
[][]During re-qualification of critical equipment/utility, only 00 and PO shall be performed. PO shall be conducted with one batch only.

[][]Re-qualification criteria for non critical equipment.
[][]Re-qualification of non critical equipment shall be conducted whether there is significant change that has influence on quality of product.
[][]For re-qualification of non-critical equipment, history of maintenance and utilization of the equipment shall be reviewed and documented as per format of Re qualification of non-critical Equipments (Attachment 1).
[][]All non – critical equipments shall be re-qualified after every three years ± 6 months.

Re-qualification criteria for Instrument in following conditions:

[][]When the instrument is shifted from one laboratory (Change in premises) to another laboratory, re qualification (10, 00 and PO) is required.
[][]When the instrument is upgraded or after having a major repairing, qualification (OO/PO) is required.
[][]When the instrument is shifted within the laboratory premises (one room to another room), re qualification is not required, in house calibration is required.

Re-qualification criteria for HVAC System:

[][]Re qualification of HVAC(AHU) shall be carried out in below mention criteria, but not limited to Change in a location of the equipment/system.
[][]Major change in equipment, Change of spare/ parts that have a direct bearing on the Performance of the equipment.
[][]Schedule Re-Qualification.
[][]Frequency of Re-qualification of AHU shall be One Year.± One month. Below mentioned test shall be carried out at defined frequency.

Parameter/Frequency

=>Air Velocity /Initially and Once in year
=>Air Changes /Initially and Once in year
=>Filter Integrity Test /Initially and Once in year
=>Particle Count /Initially and Once in year
=>Microbial Count /Initially and Once in year
=>Air Flow Direction /Initially and Once in year
=>Air Flow Pattern /Initially and Once in year
=>Recovery Study /Initially and Once in year

Re-qualification criteria for LAF:

[][]Re qualification of LAF shall be carried out in below mention criteria, but not limited to.
[][]Change in a location of the equipment/system.
[][]Major change in equipment, Change of spare/ parts that have a direct bearing on the Performance of the equipment.
[][]Critical gauges shall be replaced or corrected if the gauge is found out of calibration during calibration of the gauges.
[][]Schedule Re qualification.
[][]Frequency of Re-Qualification of LAF shall One Year.± One month.

Re-qualification criteria for utilities:

[][]Re-qualification shall be carried out to ensure that change I modification in utilities remain under
[][]Control and within the parameters defined and certified.
[][]Re qualification of utilities shall be carried out in below mention criteria, but not limited to.
[][]Change in location

[][]Any modification that has a potential to impact the product quality.
[][]Scheduled re-qualification after every 3 years.

Re-Qualification of Compressed Air:

[][]Re qualification of Compressed Air shall be carried out in below mention criteria, but not limited to,
[][]In case of any modification which has impact on product quality.
[][]Scheduled re-qualification after everyone year.

Annexure:

Annexure-I: Requalification of non-critical Equipment’s

CAPA, Purpose:

CAPA, The purpose of this document is to define a systemic, standardized and effective approach to ensure that a system is in place to address quality and compliance issues and to continually improve operations by identifying any required remedial, corrective and preventive actions and implement them in a controlled fashion.

CAPA, Scope:

The process applies to quality related non-conformities or undesirable situations in XX Pharmaceuticals Ltd. (Both General & Sterile Block) from any one of the following interface processes where CAPA is required to prevent recurrence or potential occurrence of the :
[][]Critical or major deviation.
[][]Critical or major justified market complaints.
[][]Outcomes of change control procedure
[][]Internal audit
[][]Risk Management
[][]Product incidents and recall
[][]Batch rejects and reworks
[][]Periodic product reviews
[][]Stability Test Failure
[][]Out of specification results investigations.
[][]Output of monthly quality review meeting
[][]Any other investigation
[][]The process does not apply to the following as these are managed separately by individual SOPs:
[][]Minor deviation.
[][]Triggered from various gap analysis

Definitions / Abbreviation:

[][]QA: Quality Assurance
[][]SOP: Standard Operating Procedure
[][]CAPA: Corrective action and preventive action
[][]Remedial action: Action to eliminate the immediate compliance issue associated with a deviation or non conformance.
[][]Corrective action: Action to eliminate the cause of a detected non conformity or other undesirable situation & avoid reoccurrence.
[][]Preventive action: Action to eliminate the cause of a potential non conformity or any undesirable potential non conformity & avoid occurrence.

Responsibilities:

The roles and responsibility is as follows:

Head of Quality Assurance or his/her Designee

[][]Provide effective governance of the CAPA process
[][]Ensure local process are managed according to SOP
[][]Post approved CAPA in CAPA tracking system and update it
[][]Follow up and verify close-out
[][]To authorize the closure CAPA’s

Functional Head or his designee

[][]To approve and ensure implementation of the solution into routine use

CAPA owner

[][]Accountable for CAPA objective
[][]To assess possible impact on other functions
[][]Nominate CAPA leader
[][]To approve implementation of the solution into routine use.
[][]To implement the CAPA into routine use
[][]To collect data for long term monitoring of the CAPA

CAPA Team

[][]To support CAPA leader by means of their knowledge skill and experiences.
[][]To review and accept root cause and objective.
[][]To select best solution option(s) for evaluation.
[][]To select solution for implementation into routine use.
[][]Track and close out as per commitment and target date
[][]Provide physical evidence of CAPA closing

Manager, Quality Assurance

[][]Nominate CAPA Team.
[][]To select best solution option(s) for evaluation.
[][]To select solution for implementation into routine use.
[][]To approve implementation of the solution into routine use.
[][]To record and approve closure
[][]Define ongoing monitoring criteria of the Process Owner.
[][]To review and approve the root cause and objective.
[][]To assess the possible impacts on other functions
[][]Ensure that process is ‘in place’ and ‘in use’
[][]To approve implementation of the solution into routine use
[][]Approve changes to an agreed CAPA or date extension request

Procedure:

CAPA Objective

[][]After identification of a significant quality and compliance incident (triggered by any one of the interface process stated in scope) Departmental Head/CAPA Owner will prepare the [][]CAPA objective. Source of the CAPA objective may be anyone from the following:
[][]Formal investigation report according to SOP on Deviation & Investigation
[][]Audit findings and Audit report
[][]Significant risk in the Risk Register
[][]Investigation report triggered from OOS/Stability Failure/Market Complaints/Recall/ Change control
[][]Out comes from monthly quality review meetings

[][]CAPA objective constitutes the following information:
=>Current Situation/Problem to be solved
=>Actual or most probable root cause.
=>Criticality Classification (Critical/Major/Minor)
=>Time scale for resolving the issue depending on criticality.

[][]Departmental Head/CAPA owner is accountable for CAPA objective. Depending upon the criticality/priority settings in CAPA objective, CAPA owner will take the role of CAPA leader or assign a competent person as CAPA leader.
[][]The CAPA Leader will request for a reference number from the Quality Compliance. The number format will be as CAPA/YY/XXX, where YY represent for the last two digit of a year and XXX stands for the three digit sequential number derived from a CAPA register (Annexure-III) maintained by Quality Compliance personnel.

CAPA Team:

[][]Manager, Quality Assurance determines the Leader Depending upon the nature of CAPA objective and CAPA leader may form a team.
[][]For simple CAPAs one person may take the roles of Owner, CAPA leader and CAPA team.
[][]For complex CAPAs Operators, inspectors and others involved directly with the manufacture of affected product or processes should be considered for CAPA team membership.
[][]Based on the gravity, Functional Head/Department Manager will allocate resources to CAPA team.

Review & Source of CAPA :

[][]The CAPA team will review the source and all data gathered during preparation of investigation of incidence of CAPA to ensure that full understanding of the root cause.
[][]If team requires additional data they will identify and drive to collate it.
[][]Based on the risk analysis of the root cause, CAPA leader will define the criticality of the CAPA as critical, major or minor.

Determine the scope:

[][]The CAPA team will determine the possible impact of root cause on other functions/departments and record it as scope of CAPA.
[][]CAPA leader will record all the above information in the designated place of CAPA form (Annexure I)

Define and agree solution options:

[][]Determine Ideal Solution specifications
=>The CAPA team will prepare a list of criteria for an effective CAPA which will lead a robust and permanent solution to the problem. These will include any critical success factors, without which the solution will not work.
=>It may include resources required, particular people need to involve or get support from, or time constraints, cost and communication.

Develop a list of solutions

[][]The CAPA team will list all possible solution options either to eliminate the root cause permanently or to mitigate the problem where it is not possible to eliminate the root cause.

Assess the solutions

[][]The CAPA team will assess each solution option, or combination of options against ideal solution specification to determine the best solution option. At this stage the CAPA team considers practicalities such as cost effectiveness, ease of implementation, reduction of associated risk and ability to meet business needs.

Select the solution option (s)/Actions

[][]After assessment CAPA team will select the best solution option for implementation. For maximum CAPA only one selected option will meet all the criteria/requirement to eliminate/ mitigate the root cause. (At least mitigate the risk if it is not possible to eliminate the root causes).
[][]Where more than one solution options are available, select the solution which best meets the acceptance criteria.
[][]CAPA leader can escalate the issue to Monthly quality review meeting where it is not possible to define and select any solution for a CAPA objective.

Approval of proposed CAPA:

[][]Proposed CAPAs that require any trial or changes to process, ways of working, procedures or equipment, CAPA leader will raise Change Control which will be progressed through Change Control Procedure through SOP.
[][]For all major/critical CAPA, CAPA leader will consider the requirement of following at this stage:
[][]Requirements of revision/creation of any controlled documents (SOP, BMR or BPR) and associated training.
[][]Resume of operation until the CAPA is complete.
[][]CAPA leader will ensure the closing of Change Control within the defined timeframe.
[][]Then CAPA leader will submit the dully filled CAPA form (Annexure I) to Manager, Quality Assurance and Audit along with associated Change Control and validation report (if available).
[][]Manager, Quality Assurance will review and ensure that all necessary input and decision point is available in CAPA form.
[][]He/She will ensure that while developing the CAPA scope is clearly and comprehensively defined. If he/she finds any short coming CAPA will sent back for further review.
[][]After approval/authorization, QA personnel will post the CAPA in the CAPA tracking system and handover the original CAPA form to CAPA leader.

Closing of CAPA:

[][]CAPA leader will coordinate the implementation of CAPA within agreed timeframe and collect the short term monitoring data (if available).
[][]During implementation for any deviations, changes or delays to the plan, CAPA owner will raise a date extension request (Annexure II).
[][]QA Executive will ensure that an assessment of the delay has been properly conducted and will forward it to Manager, Quality Assurance.
[][]Manager, Quality Assurance will review the date extension request and the risk assessment conducted. If the justification and risk assessment appropriate, he/she will approve it and QA Executive will update the CAPA Tracking system accordingly.
[][]All date extension approvals will be formally endorsed in Monthly Quality Review Meeting.

[][]CAPA leader and CAPA owner both define the monitoring system for short and longer term monitoring of the effectiveness of the solution. Monitoring system may include any of the following (but not limited to):
=>Monthly Quality review meeting
=>Specification
[][]Duration and levels of monitoring (e.g. higher frequency initial, lower frequency longer term, extensive sampling for impacted batches etc.)
Note: For CAPA where Change Control is not required, CAPA leader and CAPA Owner directly define the monitoring criteria.

[][]After closing CAPA leader will submit the duly filled CAPA form along with closing evidences to Manager, Quality Assurance for verifying the effective closing of the CAPA. Manager, Quality Assurance will ensure that CAPA has been effectively closed.
[][]QA personnel will update the status of CAPA tracking system and post the necessary closing evidences.
[][]CAPA owner is responsible for implementing/sustaining the CAPA as routine activities.

Review of CAPA effectiveness:

[][]If requirement of long /short term monitoring data is defined as a part of monitoring system, CAPA owner will collate and communicate the monitoring data or trend to AGM, Quality Assurance for review.
[][]Executive, Quality Assurance will categorize, trend and sort the area/systems from where maximum CAPA has been triggered. He will conduct an unnoticed inspection at any time to verify the sustainable improvement of those particular systems.

Annexure:

Annexure I- Corrective and preventive action (CAPA) form
Annexure II- Date extension request
Annexure III- CAPA Issuance Log Book

Instrument Numbering, Purpose:

Instrument Numbering, To provide a system for allocating identification number to Laboratory instrument in order to have better traceability and reference in all related documents.

Instrument Numbering, Scope:

This SOP is applicable to all Laboratory instruments and equipment’s installed in quality control laboratory, microbiology laboratory, product development laboratory and IPC laboratory of General block and Sterile block at XX Pharmaceuticals Ltd.

Definitions / Abbreviation:

[][]SOP: Standard Operating Procedure.

Responsibilities:

[][]The roles and responsibility is as follows:

Concerned Personnel

[][]He / she shall be responsible for assigning / allocating the sequential number to all equipment / instrument.

Quality Assurance Personnel

[][]He / she shall be responsible for effective implementation and monitoring of procedure.

Manager, Quality Assurance

[][]To ensure effective implementation of SOP.
[][]To approve the document.

Procedure:

[][]Numbering for Individual Laboratory Instrument:
[][]Each individual Laboratory instrument shall be assigned on unique identification number.
[][]Concerned department shall assign the sequential number to all instruments at the time of Installation Qualification and record the details in respective department register as per Annexure-II.
[][]Do not repeat the same number to another instrument.
[][]Give identification no. to all instruments as XXX/YY/000.

Where,
=>XXX corresponds to three alphabets denoting the area code of the Laboratory.
=>YY corresponds to two alphabets denoting the instrument name as per approved list available in Annexure-I.
=>000 corresponds to three numerical figures starting from 001 denoting the number of instrument in continuous manner.
=>As per Example of Balance GQC/BA/030

Where,
=>GQC = Corresponds to three alphabets denoting the Area code of Quality Control Laboratory at General Block.
=>BA = Corresponds to two alphabets denoting the instruments code.
=>030 = Number of instruments in continuous manner.

The Area Code for each Laboratory is given below:

Area Description/ Area Code

[][]Quality Control Laboratory (General Block)/ GQC
[][]Quality Control Laboratory (Sterile Block)/ CQC
[][]In-Process Laboratory (General Block)/ GIP
[][]In-Process Laboratory (Sterile Block)/ CIP
[][]Product development Laboratory (General Block)/ GPD
[][]Product development Laboratory (Sterile Block)/ CPD
[][]Microbiology (General Block)/ GMB
[][]Microbiology (Sterile Block)/ CMB

[][]Quality Assurance will prepare the Master list of Laboratory instrument with identification number and get it approved by Manager, Quality Assurance as per Annexure-III.
[][]Update the list and approve it whenever require and give serial number to list prepared.
[][]All instruments will be tagged containing instrument name and Identification number (Bold Type). Format of instruments identification tag is as follows:

INSTRUMENT / DEVICE

Name:

ID Number:

[][]In case of advent of new type of instruments, there is an option for extending Annexure-I by hand writing of Manager, Quality assurance with signature and date without reviewing the whole SOP.
[][]For this, the respective department will inform to it to the Quality Assurance Department for new code number.
[][]The new instrument (Handwritten by Manager, Quality Assurance) will be included in SOP during the next version.

Annexure:

Annexure-I: Code number for Laboratory Instrument.
Annexure-II: Laboratory Instrument Register.
Annexure-III: Master List of Laboratory Instrument

Batch Tailing, Purpose:

Batch Tailing, To establish general guidelines for batch tailing of products. It is the process whereby residual defective product (e.g. Granules, broken tablets, capsules etc.) which is satisfactory on quality, is to be added to the subsequent batches as a relatively small portion of the final batch quantity (where to be added) without affecting the quality of finished product.

Batch Tailing, Scope:

This procedure is applicable for oral solid dosages form that manufactured at XX Pharmaceuticals Limited (both General and Sterile Block).

Definition / Abbreviation:

[][]N/A

Responsibilities:

[][]The roles and responsibility are as follows:

Production Personnel

[][]To ensure that the residual product to be added is physically and chemically okay and the entire process is done following SOP.

Concerned department head

[][]To ensure that above procedure is followed properly.

Quality Assurance personnel

[][]To monitor the entire process done according to SOP.

Manager, Quality Assurance

[][]Approval of the SOP.

Procedure:

Storage and Selection Criteria of Batch Tail:

[][]The product/material to be added shall be kept in a double lined poly bag in a container with lid closed by mask tape.
[][]The container and the polybag shall be labeled properly mentioning Product Name, Batch No., quantity and date of manufacturing and to be stored in cool & dry place of well-defined areas of production.
[][]Only Product from approved batches can be added.
[][]If any batch is reprocessed once, leftover material of that batch must be disposed immediately.
[][]Addition of any leftover material/product shall be completed within the same manufacturing month or subsequent month. In case of slow moving product, it shall be completed with next manufacturing batch but the difference between two batches shall not exceed more than 3 months.
[][]Products/materials must not be added from a batch which is kept for more than three months (i.e. 90 days) in bulk condition (e.g. bulk tablets, bulk powder of capsules, blended pellets etc.).
[][]Within above time limits, if there is any sign of deterioration of the product is seen visually, they must be discarded.
[][]The weight of the material/product to be added should be equal to or less than 5% of the original batch size (weight) of the product. Maximum 10% can be allowed with justification.
[][]If the quantity is huge, a reprocessed batch can be manufactured using all tailed quantity. In that case, Batch No., Mfg. & Exp. Date shall be according to the oldest batch of accumulated batches.
[][]Powder for Suspension cannot be added to any other batch(s). This is to be discarded with proper reconciliation in the batch document.

Steps for prior Approval of Batch Tailing

[][]Concerned department Executive shall raise Batch Tailing Form (Annexure-I) and fill up the relevant information in section A & B. There must be clear statement regarding the reason for Batch tailing.
[][]In section C of Batch Tailing Form, Manager of concerned department shall provide his comments ensuring the statement provided by his officer and suitability of reprocessing/reworking of the product.
[][]Before taking decision of addition of batch tailings to subsequent batch, physical verification of batch tails must be carried out by Quality Assurance Executive and shall record observation in section D of Batch Tailing Form.
[][]In section E of Form, Manager, Quality Assurance shall give comments to ensure its suitability of re-use.
[][]In section F of Batch Tailing Form, comments shall be given by General Manager, Plant.
[][]In section G of Form, Head of Quality Assurance shall provide comments regarding approval.
[][]The approved Batch Tailing Form shall be the part of batch records

Annexure:

Annexure – I: Batch Tailing From

Good Documentation Practice, Purpose:

Good Documentation Practice, To define the common practice to be followed for data entry in all GMP / GLP records.

Good Documentation Practice, Scope:

This procedure is applicable to all GMP / GLP records filled manually at XX Pharmaceutical Limited (Both General & Sterile Block). This SOP is general guideline and will be superseded whenever any specific requirements are mentioned in other SOP or approved document.

Definitions / Abbreviation:

[][]GMP / GLP Records: GMP / GLP records are defined as all records which directly or indirectly and individually or collectively control the strength, identity, safety, purity and quality of drug product.
[][]Annotate: To add explanatory notes.
[][]SOP: Standard Operating Procedure.
[][]N/A: Not Applicable

Responsibilities:

[][]The roles and responsibility is as follows:

Concerned Personnel

[][]To carry out the documentation as mentioned in SOP.

Department Head or Designee

[][]To ensure training and implementation of SOP.

Manager, Quality Assurance

[][]To ensure implementation of SOP.

Procedure: Good Documentation Practice

[][]General Guidelines for documentation practices:
[][]Sign and date all data entries on the date of data entry, as applicable.
[][]Date to be written numerically in the DD/MM/YY form. E.g. write 13/01/16 for 13th January 2016.
[][]Time to be written numerically in the HH:MM form in the document using 12 hours cycle daily. For e.g., 8:30 AM, 4:30 PM etc.
[][]Time duration to be written as shown below:
[][]e.g. If for some process the observed time duration is 2 minutes and 30 seconds then it’s should be written as 2min 30 sec and not as 2:30min.
[][]In case of wrong entry, strike out with single line and put initial and date nearby it. Do not overwrite or block the wrong entry.
[][]Do not leave blank space, Write N/A.
[][]Do not use the ” if the entry is repeated in next line.
[][]Use of pencil is not allowed.
[][]Correction fluid / white ink / eraser should not be used.
[][]Entries to be made in legible handwriting.
[][]Unusual observations shall be recorded, signed and dated.
[][]Entries in logbook shall be done in the chronological order.

General Guidelines for using indelible ink pen:

[][]Write all GMP records only with permanent BLUE indelible ink pen.
[][]Permanent BLUE indelible ink pen should be used for signing of master documents.
[][]The QA supervisor should use the permanent GREEN indelible ink pen to sign after checking the data on shop floor.
[][]Data entries should be recorded, signed and dated immediately after the completion of each activity, as applicable.

Correction of Recording Error / Overwriting or Incorrect Entry:

[][]In case of any wrong entry, do not over write or block the entry to make it obscure or unreadable. Strike out the wrong entry with straight single line passing through incorrect entry in [][]such a way that it remains readable.
[][]Make correct entry nearby it.
[][]For major changes annotate the actual reason for the correction or change, as the case may be.
[][]The correcting person shall put the initials along with date on which correction was done.
[][]Suppose ‘Cleaned’ is recorded in place of ‘Ensured’ by mistake on 10/01/XX and observed later during BMR review on 18/01/XX, it can be corrected at later date in the following way:
[][]Correct way for Correction on 18/01/XX:
[][]Initial Cleaned Ensured
[][]Date
[][]If space is not sufficient for correction, strike out the wrong entry with single line and highlight the same with an asterisk (*) nearby it. Define the asterisk at the bottom of the page and [][]Correct the wrong entry with initial and date.
[][]Entry of Missed Step:
[][]Entry of any missed step can be done later only if it can be proved that the step had been performed but the doer/performer and/or checker failed to document the same.
[][]The person making entry of missed step shall put the initials along with the date on which entry is done nearby entry of missed step.
[][]Working with Blank or Unused page/space :
[][]Do not leave blank space in any GMP record.
[][]Strike out any blank space or page with cross line and write in between the line N/A.
[][]Put initial and date at the end of the line, e.g., for following unused space strike out as specified :

Rounding – off of values:

[][]The rounding off values is applicable only to the calculations and not to the observed readings. Limits which are fixed numbers shall not be rounded off.
[][]e.g., If limit is 2 – 8 °C, then observed value 8.2 cannot be rounded off. Any value or figure which displayed by any equipment/instrument shall not be rounded off, e.g. if pH meter displayed is 3.79 than it should be mentioned as such and should not be rounded off to 3.8.
[][]When rounding off of any value is required, follow the below procedure.
[][]If last digit is equals to or greater than 5, it is eliminated and the preceding digit is increased by one.
[][]If last digit is smaller than 5, it is eliminated and the preceding digit remains unchanged.
[][]For examples see the below Illustration:
[][]Illustration of Rounding of Numerical Values for comparison with Requirements
[][]Requirements: Product Yield Limit (99.0% to 101.0%)

Unrounded Value to Rounded Value

[][] 98.926 shall be 98.93
[][] 100.124 shall be 100.12
[][] 99.655 shall be 99.66

Assigning Due Date:

[][]For assigning Due Date in all GMP records, calculate due date as per frequency for that particular activity from the day on which that activity is performed.
[][]Status of the activity can be valid up to the due date.
[][]For example, consider the case of assigning due date for re-cleaning of pre-filter for which cleaning frequency is 15 days.
[][]Suppose cleaning of pre-filter is done on 02/01/XX, since frequency of pre-filter is 15 days, due date for re-cleaning of pre-filter can be assigned 16/01/XX and cleaning can be considered valid up to 16/01/XX.
[][]Record all information in legible handwriting in all GMP records.
[][]Printouts from the instruments relevant to the analysis shall be retained and no such document shall be discarded even if they are not of use in the calculation.

Additional Documentation Practices for Quality Control Laboratory:

[][]Entries like “Complies/Does not comply” only allowed for the binary observations but the binary observation shall be specific.
[][]E.g. Limit test shall mention the observation noticed and TLC shall mention the comparison with the spot.
[][]Calculations shall be documented and rounding off shall be done as per SOP.
[][]Concordance of another analyst shall be taken for observations of subjective tests. E.g. limit tests, TLC plates etc. Both the analyst shall initialize and sign the observation.
[][]Printouts from the instruments relevant to the analysis shall be retained and no such document shall be discarded even if they are not of use in the calculation.

Annexure: Good Documentation Practice

N/A

Labelling , Purpose :

Labelling , To describe the procedure for status labeling to identifying correct status of Equipment, area, Stage of product, Raw Material & Packaging Material at a given point of time.

Labelling , Scope :

This procedure is applicable for all materials/products received and stored in General Block & Sterile Block at XX Pharmaceuticals Ltd. that has the potential to affect GMP and quality, safety or efficacy of the finished product.
This procedure is also applicable for control of status identifying labels, process label and product labels used in Production, Warehouse, Quality Control and Quality Assurance departments in General Block & Sterile Block at XX Pharmaceuticals Ltd.

Definitions / Abbreviation:

[][]Labeling: Displaying status and identity of a material or a thing.

Responsibilities:

[][]The roles and responsibility is as follows:

Concerned Department

[][]Concerned department Officers/ Executive shall be responsible to carry out the activity as per procedure.
[][]To affix the status label as per procedure.

Head, Concerned Department

[][]Concerned Department Heads shall be responsible for effective implementation of procedure and activities.

Quality Assurance

[][]To ensure implementation of labeling procedure & proper labeling as per SOP.

Manager, Quality Assurance

[][]Approval of the SOP.
[][]To ensure the overall implementation of the SOP.

Procedure:

[][]In order to avoid mix-ups and contamination, for easy identification and traceability, of product and to ensure working as per GMP standards it is important to affix status label at each stage of process on equipment’s, products, containers, accessories and areas. Labels of various types are used in manufacturing functions.
[][]The purpose, type and use of each label are described as below.

General procedures for label handling:

[][]Every status-identifying label shall have distinctive format number and master copy for all computers generated and printed label formats shall be preserved securely under lock and key with Manager, Quality Assurance.
[][]Each and every container of active pharmaceutical ingredients (APIs), excipients, raw materials, intermediate products, primary and printed packaging components will have to be labeled denoting proper status.
[][]Every supplier batch will have status label (e.g. Passed label) with one unique batch/ lot number.
[][]For tertiary packing materials (product nonspecific i.e. shipper carton, master carton) pallet wise labeling process will be followed.
[][]All labels will be preprinted self-adhesive labels which provide blank space for printing/ writing necessary information.
[][]After printing/ generating of status label an authorized person will verify the correctness of printing.
[][]Containers/packs where self-adhesive label cannot be pasted securely (Sack/ polythene bag) transparent tapes will be used at every side for affixation. Stapler pin will never be used for affixation of label.
[][]No material/ product/equipment without status label shall be stored either in the warehouse or production floor.
[][]Warehouse personnel cannot issue material from any container to production where ‘PASSED’ label is not available.
[][]During dispensing of active raw materials, Officer/ Executive will ensure that every container contains three status label (QUARANTINED, SAMPLED, UNDER TEST and PASSED).
[][]In case of other raw materials (excipients) & packaging materials, all containers/ pack/ pallet must have ‘UNDER TEST’, ‘PASSED’ and ‘QUARANTINED’ label. ‘SAMPLED’ labels will be found between ‘QUARANTINED’ and ‘UNDER TEST’ label only on containers from which the samples were taken.

[][]Label must not be applied on the container lids.
[][]Labels will be applied on the body of the containers so that it will be easily visible. Label must not be overwritten and erased out.
[][]Labels will be handled securely in a segregated manner (under the custody of an authorized person) with controlled access.

Quarantined Label:

[][]After receipt and checking of incoming materials, warehouse Officer/ Executive will print ‘QUARANTINED’ labels with necessary information for all containers/packs for each batch of materials.
[][]Authorized warehouse personnel will provide all the entry required for ‘QUARANTINED’ label.
[][]Warehouse Officer/ Executive will verify and ensure that all the information printed on the labels of first sheet is correct and then will give command to authorized warehouse personnel for printing total ‘QUARANTINED’ labels required for the respective lot. Any label with printing error will be destroyed instantly.
[][]Warehouse Officer/ Executive will sign (issued by) and authorized person of the warehouse will affix all ‘QUARANTINED’ labels on each container of the incoming materials.
[][]This label is printed with black overprint on Orange background.

Approved Label:

[][]Quality Assurance Executive shall affix the ‘Approved Label’ on respective process container after receiving the certificate of analysis of that material / Product from QC.
[][]Quality Assurance Executive shall issue this label to approving In-process Granules/Powder, Uncoated /Coated Tablet for Work in progress.
[][]This label is printed with black overprint on Blue background.

Sampled Label:

[][]On receipt of Good Received Note (GRN) from warehouse, QC personnel will follow the SOP for Raw material sampling and release procedure or SOP for Packing material sampling and release procedure to determine the sampling plan and the number of the containers to be sampled.
[][]QC Officer/ Executive/ authorized person will issue and print required ‘SAMPLED’ labels according to sampling plan.
[][]After sampling, duly signed ‘SAMPLED’ label will be affixed on the containers or packs from which samples are withdrawn.
[][]The ‘SAMPLED’ label will be affixed beneath the ‘QUARANTIED’ label in a cascading manner (slight overlapping) without hiding any information of ‘QUARANTIED’ label.
[][]This label is printed with black overprint on Yellow background.

Hold Label:

[][]Manager, Quality Assurance may hold any raw material, packaging material or finished product when necessary.
[][]Quality Assurance personnel will print ‘HOLD’ label with necessary information.
[][]After signed by authorized person, Quality Assurance personnel will affix ‘HOLD’ label on the pallet/ container that will be hold for long time for a decision of passing or rejection.
[][]When final decision of passing or rejection is taken, Quality Assurance personnel will remove the ‘HOLD’ label and destroy them. Then, ‘PASSED’/ ‘REJECTED’/ ‘APPROVED’ labels will be affixed.
[][]This label is printed with black overprint on orange background.

Passed Label:

[][]QC Officer/ Executive will follow the SOP for Raw material sampling and release procedure or SOP for packing material sampling and release procedure and issue the ‘PASSED’ label.
[][]QC officer / Executive will take required sheets of blank ‘PASSED’ labels. The quantity of ‘PASSED’ label will be based on number of containers/packs for each batch of materials
Officer/ Executive, QC will provide all the entry required for ‘PASSED’ labels and take the print-out of one page first.
[][] Another Officer/ Executive, QC will verify and ensure that all the information printed on the first sheet of labels is correct and then will give the command for printing total ‘PASSED’ labels required for the respective lot. Any label with printing error will be destroyed instantly. Officer/ Executive, QC will sign ‘PASSED’ labels.

[][]Authorized QC person will affix the ‘PASSED’ label on each and every single container of raw materials or packaging materials with the help of warehouse personnel.
[][]‘PASSED’ label will be affixed just beneath the ‘UNDER TEST’ label in a cascading manner (slight overlapping) without hiding any information of previous label.
[][]This label is printed with black overprint on Green background.

Rejected Label:

[][]QC Officer/ Executive will follow the SOP for Raw material sampling and release procedure or SOP for packing material sampling and release procedure and issue the ‘REJECTED’ label.
[][]QC officer will take required sheets of blank ‘REJECTED’ labels. The quantity of ‘REJECTED’ label will be based on number of containers/packs for each batch of materials
[][]Officer/ Executive, QC will provide all the entry required for ‘REJECTED’ labels and take the print-out of one page first. Another Officer/ Executive, QC will verify and ensure that all the information printed on the first sheet of labels is correct and then will give the command for printing total ‘REJECTED’ labels required for the respective lot. Any label with printing error will be destroyed instantly.
[][]Manager, QC will sign ‘REJECTED’ labels.
[][]Authorized QC person will affix the ‘REJECTED’ label on each and every single container of raw materials or packaging materials with the help of warehouse personnel.
[][]‘REJECTED’ label will be affixed just beneath the ‘QUARANTIED’ label or ‘UNDER TEST’ label in a cascading manner (slight overlapping) without hiding any information of previous label.
[][]This label is printed with black overprint on Red background.

Under Retest Label:

[][]Ware house Officer will identify any requirement for retesting of materials and immediately paste a ‘UNDER RETEST’ label on the container just beneath the previous ‘PASSED’ label and transfer the material to quarantined area. Warehouse Officer will inform the Manager, QC to arrange sampling for retesting
[][]This label is printed with black overprint on Yellow background.

Returned label

[][]The ‘RETURNED’ Label is displayed on the container/material for identification of Product status.
[][]Concerned Department shall affix this label on excess material that is to be left after Primary Processing, e.g Drying/ Pulverization/ packaging operation.
[][]Ensure that the materials returned are clean, free of dust, properly covered and in uniform countable bundles or pack.
[][]This label is printed with black overprint on White background.

Cleaned Card Label

[][]The “CLEANED” label is displayed for the identification status of the equipment after completion of cleaning activity.
[][]Use this label after complete cleaning, as per SOP.
[][]In case of start of the operation, filled this label to be affixed in BMR/BPR.
[][]This label is printed with black overprint on green background.
[][]Following are the details to be filled up in the respective blank spaces. Label to be filled by operator / supervisor.
[][]Equipment Name: Name and/or ID no of the equipment, which is cleaned.
[][]Previous Product: Name of the product for which cleaning activity is completed in that particular equipment.
[][]Batch No.: Batch No. of the above product.
[][]Date of cleaning: Date on which equipment is cleaned.
[][]Use on or before: Date before which equipment can be used.
[][]Cleaned by: Signature or name of the person by whom equipment is cleaned.
[][]Checked by: Signature of production supervisor after verification of the filled contents in the label and after visual verification of cleanliness of the equipment.
[][]Verified by: Signature of the QCOM person, after visual verification of cleanliness of the equipment’s.
[][]To be used for product: The product which will be taken for process after the equipment cleaning.
[][]Batch No.: Batch no. of the product which will be taken for process after equipment cleaning.

Partially Cleaned Label

[][]The PARTIALLY CLEANED label is displayed for the identification status of the equipment after completion of cleaning activity.
[][]Use this label after partial cleaning, as per SOP.
[][]In case of start of the operation, filled this label to be affixed in BMR/BPR.
[][]This label is printed with black overprint on Yellow background.
[][]Followings are the details to be filled up in the respective blank spaces. label to be filled up by the operator/ supervisor.
[][]Equipment Name: Name and/or code no of the equipment, which is cleaned.
[][]Previous Product: Name of the product for which cleaning activity is completed in that particular equipment.
[][]Batch No.: Batch No. of the above product.
[][]Date of cleaning: Date on which equipment is cleaned.
[][]Use on or before: Date before which equipment can be used.
[][]Cleaned by: Signature or name of the person by whom equipment is cleaned.
[][]Checked by: Signature of production supervisor after verification of the filled contents in the label and after visual verification of cleanliness of the equipment.
[][]Verified by: Signature of the QCOM person, after visual verification of cleanliness of the equipment’s.
[][]To be used for product: The product which will be taken for process after the equipment cleaning.
[][]Batch No.: Batch no. of the product which will be taken for process after equipment cleaning.

To be Clean Label:

[][]This label is displayed for the identification status of the equipment, accessories and containers after its use.
[][]Followings are the details to be filled up in the respective blank spaces. label to be filled up by the operator/ supervisor.
[][]Previous Product: Name of the product for which processing activity is completed in that particular equipment.
[][]Batch No.: Batch No. of the above product.
[][]Signature: Signature of the production supervisor after verification of the filled contents in the label.
[][]Date: Date on which the equipment is due for cleaning.
[][]This label is printed with black overprint on Orange background.

Loose Label:

[][]‘Loose’ Label is to be affixed on loose container/shipper by Production Department.
[][]This label is printed with black overprint on White background.
[][]Executive, Production will provide all the entry required for ‘Loose’ labels and take the print-out. Any label with printing error will be destroyed instantly.

Material Dispensing Slip Label:

[][]This label is displayed for the identification status of the Dispensed Material.
[][]Use this label during of dispensing of material as per SOP.
[][]Officer/ Executive, Production will provide all the entry required for this label and take the print-out.
[][]In case of start of the operation, Executive, Production will affix this label in BMR.
[][]This label is printed with black overprint on White background.
[][]Followings are the details to be filled up in the respective blank spaces.
[][]Balance No.: Name of the Balance ID
[][]Operation: Material dispense for either Granulation or Coating.
[][]Material: Name of the Raw material
[][]Code: Code No. of the Raw material
[][]Lab Ref. No.: Lab Control No. of the Raw material
[][]Product: Name of the product that is to be manufactured.
[][]Batch No. : Batch no. of the concerned product.
[][]Batch size: Actual batch size of the concerned product.
[][]Gross Wt.: Total weight (wt) of the filled container without lid in kilogram (kg).
[][]Tare wt.: Weight of the empty container along with Polyethylene bags without lid before taking it in use in kg.
[][]Net Wt.: Subtract the tare wt. from gross wt. in kg.
[][]Container No.: Number of that particular container out of total no. of container used for the above batch.
[][]Dispensed by: Signature of dispensing Operator
[][]Checked by: Signature of Production Executive after verification of the filled contents in the label.
[][]Verified by: Signature of QCOM officer after verification of the filled contents in the label.

Process Label:

[][]This label is displayed on the container for identification of the product status.
[][]This label is to be used on the container during the manufacturing stage. For Example: Under sifting, under granulation, under solution preparation, Ready for Granulation / Drying / [][]Blending / Solution ready for coating.
[][]This label is printed with black overprint on White background.
[][]Following are the details of preprinted label to be filled up in the respective blank spaces and to be filled by operator / supervisor.
[][]Product: Name of the product collected / to be collected in the container.

[][]Batch No.: Batch no. of the concerned product.
[][]Status: Stage in which the product is ready for next step.
[][]Container No.: Number of that particular container out of total no. of container used for the above batch.
[][]Batch Size: Actual batch size of the concerned product.
[][]Mfg. Date & Exp. Date: Manufacturing and Expiry date of the concerned product.
[][]Gross wt.: Total weight (wt) of the filled container without lid in kilogram (kg).
[][]Tare wt.: Weight of the empty container along with Polyethylene bags without lid before taking it in use in kg.
[][]Net wt.: Subtract the tare wt. from gross wt. in kg.
[][]Checked by: Signature of Production officer after verification of the filled contents in the label.

Product Label:

[][]This label is displayed on the Shipper for identification of the product status.
[][]This label is to be used on the Shipper during the Secondary Packaging Operation.
[][]This label is printed with black overprint on White background.
[][]Following are the details of preprinted label to be filled up in the respective blank spaces and to be filled by operator / supervisor.
[][]Product: Name of the product collected / to be collected in the shipper.
[][]Batch No.: Batch no. of the concerned product.
[][]Mfg. Date & Exp. Date: Manufacturing and Expiry date of the concerned product.
[][]Pack Quantity: Total no. of pack in Shipper.
[][]Sr. No.: Total No. of Shipper

[][]Packed by: Name / sign of the Operator /Supervisor who are involved in shipper Making & closing.
[][]Storage Condition: Storage Condition of the concerned product.

Area / Equipment Label:

[][]This label is used to exhibit the process that is being carried out in the area/equipment, tick (√) whichever is applicable.
[][]This label is printed with black overprint on Green background.
[][]The area is labeled at the start-up of the batch.
[][]Following are the details to be filled up in the respective blank spaces. Label to be filled by operator / supervisor.
[][]Product: Name of the product taken or to be taken for processing on that particular equipment.
[][]Batch No.: Batch number of the above product.
[][]Batch size: Actual batch size in written in the BMR.
[][]Status: Particular stage of activity in process.
[][]Checked by: Signature of Production supervisor after verification of the filled contents in the label.
[][]Date: Date on which the process takes place.

Retention Sample:

[][]QC / QA officer shall affixed sample Label on the sample Poly bag or container which is to be sample for retaining.
[][]This label is printed with black overprint on White background.

[][]Officer/ Executive, QC or QCOM will provide all the entry required for ‘Retention Sample’ labels.

Cleaned Label:

[][]This label is displayed for the identification status of the accessories and containers after completion of cleaning activity.
[][]This label should not be attached with BMR/BPR.
[][]This label on containers and accessories should be defaced with a cross-line and destroyed when taken for use.
[][]In case of start of the operation, this label has to be removed from container and ‘ Process’ label to be affixed.
[][]In case of start of the operation, this label has to be removed from accessories and ‘Area/ Equipment’ label to be affixed.
[][]This label is printed with black overprint on Green background.

Under Test Label:

[][]This label is displayed on the container/ Packet for the identification status of the material/product after sampling for QC Test.
[][]QC / QCOM Executive shall affix this Label after completion of sampling activity.
[][]This label is printed with black overprint on Yellow background.

Annexure: Download all here

Annexure-I: Blank format for ‘Quarantined’ label.
Annexure-II: Blank format for ‘Approved’ label.
Annexure-III: Blank format for ‘Sampled’ label.
Annexure-IV: Blank format for ‘Hold’ label.
Annexure-V: Blank format for ‘Passed’ label.
Annexure-VI: Blank format for ‘Rejected’ label.
Annexure-VII: Blank format for ‘Under Retest’ label.
Annexure-VIII: Blank format for ‘Returned’ label.
Annexure-IX: Blank format for ‘Cleaned’ label.
Annexure-X: Blank format for ‘Partially Cleaned’ label.
Annexure-XI: Blank format for ‘To Be Cleaned’ label.
Annexure-XII: Blank format for ‘Loose’ label.
Annexure-XIII: Blank format for ‘Material Dispensing Slip’ label.
Annexure-XIV: Blank format for ‘Process’ label.
Annexure-XV: Blank format for ‘Product’ label.
Annexure-XVI: Blank format for ‘Area/ Equipment’ label.
Annexure-XVII: Blank format for ‘Sample’ label.
Annexure-XVIII: Blank format for ‘Retention Sample’ label.
Annexure-XIX: Blank format for ‘Cleaned’ label.
Annexure-XX: Blank format for ‘Under Test’ label.

Batch Numbering, Purpose :

Batch Numbering, The purpose of this SOP is to describe the procedure of batch numbering system of finished product and issuing code number of raw, packaging and finished product.

Batch Numbering, Scope :

This procedure is applicable for coding of all raw materials, packaging materials, finished products and batch numbering system of finished product at XX Pharmaceuticals Limited (Both General and Sterile Block).

Definitions / Abbreviation:

[][]Batch Number: A distinctive combination of numbers and/or letters which uniquely identifies a batch on the labels, its batch records and corresponding certificates of analysis, etc.
[][]Code Number: An arrangement of numbers providing a unique identity to the items which they are assigned.

Responsibilities:

[][]The roles and responsibility is as follows:

Executive/ Manager, Product Development

[][]To inform and request Supply Chain department that the new materials to be used for product development.

Executive/ Manager, Supply Chain

[][]Issue the unique material code number of each raw material and packaging materials and as well as finished product

Executive/ Manager, PMD

[][]To inform and request Supply Chain Department to issue material & product code for new products.

Executive/ Manager, Quality Control

[][]Implementation of the total coding system.

Executive/ Manager, Quality Assurance

[][]Implementation of the total coding and batch numbering system.

Executive/ Manager, Production

[][]Implementation of the total coding and batch numbering system

Manager, Quality Assurance

[][]Approval of the SOP.
[][]To ensure that the implementation of the system as per SOP.

Procedure:

Raw Material Coding System:
[][]Maintain seven alphanumerical characters (first three characters are alphabetic and last four characters are numerical) for Raw Material Coding System.
[][]Start the coding with ‘RM’ which stands for ‘Raw Material’ and it is common for every raw material coding system
[][]For the Active Raw Material select ‘A’ as the third character of the code. When the raw material is excipient then select ‘E’ instead of ‘A’.
[][]At last specify the code number with four numerical characters to indicate the separate material. Following this procedure, raw material code for the first enlisted Active Material (API) will be RMA0001 and the second one (API) will be RMA0002.
[][]When the same material has different categories (such as compacted, granular, pharma grade etc.) then for every category, a new code number will be generated maintaining previous procedures.
[][]For example: Raw Material Code Number ‘RMA0001’ stands for
RM=Raw Material
A=Active (In case of Excipient it will be ‘E’)
0001=Individual number of raw material

Packaging Material Coding System:

[][]Maintain seven alphanumerical characters (first four characters are Alphabetic and last three characters are numerical) for Packaging Material Coding System.
[][]First characters which stands for packaging material. Second character will be changed for primary and secondary packaging material, When primary packaging material it will be ‘P’ and when secondary packaging material it will be ‘S’.
For example
=>PP= Primary Packaging Material
=>PS= Secondary Packaging Material

[][]Next two characters which stand for sub category of packaging material. It will be changed for every sub category of packaging material as Annexure-I.
[][]Last three characters which stand for sequential number. Every sub category material starts with sequential number 001. Such as
=>AB-001= Alu- Bottom foil
=>TF-001= Alu-Lid foil
=>And so on

[][]The sequential number will be changed when different types of materials come in same sub category. For example
=>AB-001= Alu –Bottom foil 206 mm
=>AB-002= Alu –Bottom foil 183 mm
=>And so on

[][]Finally the coding system of packaging material is like
=>PP-AB-001
Where
=>PP stands for primary packaging material
=>AB-001 stands for alu bottom foil 206 mm

Finished Product Coding System:

[][]Maintain seven alphanumerical characters (first digit is alphabetic and last five digits are numerical) for finished product coding system.
[][]Start the coding with ‘P’ which stands for finished product. P is common for every finished product code numbering system.

[][]The last five digits 00001 is sequential number. It will be changed in every finished product coding system. It will be also changed when same product in different strength. For example finished product code of Cexoral 200 capsule is P-00001 and Cexoral 400 capsule is P-00002.
[][]Finally the finished product coding system is P-00001
[][]Where P stands for finished product
[][]is dash
[][]00001 stands for sequential number of individual product with strength.

Batch Numbering System for Finished Product:

[][]Maintain six characters (All six digits are numerical) for batch numbering system.
[][]First two digits stand for year. It will be changed for next year.
[][]For example
=>20AA for AA
=>20BB for BB
=>20CC for CC
And so on..
[][]The last four digits are yearly batch requisition serial number of products manufactured in XX Pharmaceutical Limited, Which (last four digits) will be started from 0001, next batch requisition serial will be started from 0002 and so on.
[][]In every new year, the last four digits (batch requisition serial number) will be started from 0001.
[][]Example for presentation of the Product Batch Number on the Inner Carton, Sample Pack, Label and Shipping Carton:
XX0001
Where
XX stands for year of 20XX
0001 sands for serial number of batch manufactured in year of 20XX.

Batch Numbering System for Water for Injection:

[][]Maintain six characters (six digits are alphanumerical) for batch numbering system.
[][]First digit stands for water for injection
[][]Second and third digits stand for year. It will be changed for next year.
For example
20AA for AA
20BB for BB
20CC for CC
And so on…

[][]The last three digits are yearly batch requisition serial number of water for injection which (last three digits) will be started from 001, next batch requisition serial will be started from 002 and so on.
[][]In every new year, the last three digits (batch requisition serial number) will be started from 001.
[][]Example for presentation of the preprinted ampoule:
WXX001
Where
[][]W stands for Water for injection
[][]XX stands for year of 20XX
[][]001 sands for serial number of batch manufactured in year of 20XX.

Annexure:

Annexure-I: Packaging Material Code