SOP of Annual Product Quality Review
To lay down a procedure to conduct Annual Product Quality Review for all pharmaceutical products.
This Standard Operating Procedure is applicable for all products manufactured at the formulation plant of the Pharmaceuticals Company (Name).
Officer / Executive – QA shall be responsible for the collection of relevant data and information required for preparing the Annual Product Review.
Head-Quality Assurance/designee shall be responsible for assuring that all provisions of this SOP are fulfilled and for the approval of the Annual Product Review.
The concerned Department Head and QA Head shall be accountable for the implementation of this SOP.
Abbreviations and Definitions
- APQR: Annual Product Quality Review – An organized and Comprehensive summary of a product, analytical and Customer data associated with a pharmaceutical product.
- Quality trends: Quality trends which include in-process and quality control data should be prepared and alert limits (trend limits) should be established for all critical parameters. The established limits should be checked and reviewed by Quality Assurance for consistency.
- STPs: Standard Testing Procedure
- AR.No.: Analytical Report Number
- Retrospective Validation: Historic data taken from the records of the previous production batches used to provide documented evidence that the process has been in a state of control prior to the request for evidence
- BMR: Batch Manufacturing Record
- M.F.No.:Master Formula Number
- CAPA: Corrective and Preventive Action
- NCRs: Non-Conforming Report
- LOD: Loss on Drying
All the batches of a product manufactured in a financial year shall be considered while preparing the APQR. For example, the batches manufactured between the months of April and March of next year i.e. a product with a cut-off date of March 31 for the APR will require all the batches released or rejected during 12 months preceding March 31 will be included in the APQR for that year.
The APQRs for all the products for one financial year shall be prepared, compiled and approved within the time period of 03 months after the closing of the financial year and on the basis of the inferences of APQR, CAPA shall be initiated within 06 month after the end of the financial year, if required.
Officer / Executive QA for preparing the APQR shall collect, summarize and review the related data from BMRs (process parameters), process deviations, change controls, NCRs, market complaints, returned goods, recalled products, etc. along with the other analytical data obtained from other departments.
Each set of data shall be tabulated and graphed in such a fashion as to easily exhibit (display) results, deviations and Quality trends etc.
QA personnel shall allocate a fourteen-digit number to the APQR form and sign with a date. The number shall be in APQR/XX/YY- ZZZ format, where
- The first four characters ‘APQR’ are abbreviation of Annual Product Quality Review.
- The second character shall be a ‘/’ (slash).
- Third and fourth character ‘XX’ represents Department Code e.g. “TB” for Tablet Section.
- Fifth character shall be a ‘/’ (slash).
- The next two characters ‘YY’ represents the year e.g. 23 for 2023 etc.
- The next character shall be a ‘-’ (dash).
- The next three characters ‘ZZZ’ represents serial number of APQR i.e. 001, 002, 003, etc.
- The first APQR of the year 2023 shall be numbered as APQR/OL/23-001.
A new series of APQR number shall start at the beginning of new calendar year.
The data shall be collected from the records and recorded in the format Annual Product Quality Review against the relevant points.
Product Description: The product’s detailed description i.e. product name, generic name, label claim, strength, packaging type, M.F.No., batch sizes available, market, shelf life, indications, and any other specific information related to the product shall be included.
The time period covered: This shall include all batches manufactured or disposition (released or rejected) during a financial year i.e. from April to March of next year.
Manufacturing and testing procedures followed for the product
Master Formula No (Manufacturing & Packaging): A record of Master Formula No. used for batches included in APQR. If there is any change in Master Formula No. then the reason for change along with change control reference no. shall be mentioned.
Specifications / STP (In-process, Finished Product & Packaging component): All the specifications / STPs reference numbers shall be given for reviewed batches. If there is any change in Specification or testing procedure, the reason for the change(s) along with change control reference no. shall be mentioned in APQR.
Finished Product Results: A summary of the finished product results of all the batches considered while preparing the APQR shall be represented. The trend of the results shall be prepared and presented suitably. Conclusion and recommendations, if any, shall be documented in the APQR.
Tablets Finished Product: average weight of tablets, disintegration time, Dissolution Time (If applicable), assay, yield or any other relevant test shall be considered but may not be restricted to these parameters only.
Capsules Finished Product: average weight of capsules, disintegration time, Dissolution Time (If applicable), assay, yield or any other relevant test shall be considered but may not be restricted to these parameters only.
Liquid Oral/Ointment/Gel Finished Product: pH, weight per ml, viscosity (if applicable), assay, yield or any other relevant test shall be considered but may not be restricted to these parameters only.
Injection/ Drops Finished Product: pH, Average weight, assay, yield or any other relevant test shall be considered but may not be restricted to these parameters only.
In-Process Results: A summary of the in-process results of all the batches considered while preparing the APQR shall be represented. The trend of the results shall be prepared and presented suitably. Conclusion and recommendations, if any, shall be documented in the APQR.
Tablets in-process: LOD, Average weight, Disintegration Test, Hardness, assay, and yield but may not be restricted to these parameters only.
Capsules in-process: LOD, water content, Average weight, Disintegration Test, yield, and assay but may not be restricted to these parameters only.
Liquid Oral/Ointment/Gel in-process: pH, weight per ml, viscosity, and assay but may not be restricted to these parameters only.
Injection/Drops in-process: pH, Average weight, and assay but may not be restricted to these parameters only
Environmental conditions during manufacturing operation: The data on environmental conditions during the manufacturing of all batches shall be reviewed and recorded in the APQR.
Critical Equipment performance: The critical equipment used during the manufacturing of the product shall be identified and the overall performance of this equipment shall be evaluated by reviewing the breakdown and preventative maintenance records. The observations shall be recorded in the APQR.
Process Deviations / Change controls: All product or process deviations, investigations conducted for deviations, or change control for the change in procedure or product parameters shall be recorded. Any corrective actions derived from these changes and the effect of these changes on product quality shall be summarized. The observations shall be recorded in the APQR.
Out of Specification and Out of trend: All the cases of out-of-specification for a particular product (API, in-process, and Finished Product and Packaging component) filed by Quality Control during the respective financial year shall be mentioned (if any). Out-of-trend results, if any, observed during stability studies shall also be recorded in the APQR.
Non-Conformance Report: All details of the non-conformance report generated in the respective financial year for the particular product shall be mentioned (if any) in the Annual Product Quality Review.
Product complaints: Summary of all product complaints shall be summarized and any trends or problematic batches shall be additionally reviewed.
Returned goods or recalled products: Details of any returned goods or recalled batches shall be listed in the APR.
Yield reconciliation: The yield of batches of the product shall be reconciled and variations along the trend shall be observed and reasons elucidated in APR.
Adverse drug reactions: Data on adverse drug reactions, if any, shall be summarized in Annual Product Review.
Active Pharmaceutical Ingredient data: The data of API shall be collected and recorded appropriately. The data shall include the name of the ingredient, manufacturer/supplier name and address, number of consignments received, number of consignments approved, and number of consignments rejected with the cause of rejection (if any).
Raw material (API) Manufacturer / Supplier Performance review: The review of the manufacturer or supplier who is supplying the active ingredient shall be taken based on the approval and rejection record of the API received.
Conclusions and recommendations: The conclusion regarding the process consistency with respect to yield, quality, stability, and recommendations to continue the manufacture as per the process being followed.
Forms and Records (Annexures)
Annual Product Quality Review- Annexure-I
Master copy- Quality Assurance
Controlled copies – Quality Assurance
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