SOP on Annual Product Review
Objective : To lay down a procedure of Annual Product Review for the products manufactured in the respective financial year.
Scope : This Standard Operating Procedure is applicable for all products manufactured in formulation plants of for US, Domestic market, Rest of the World (ROW) or for any specific customer requirement.
Responsibility : Officer / Executive – QA shall be responsible for collection of relevant data and information required for preparing 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 Annual Product Review.
Abbreviations and Definitions
Annual Product Review (APR) : An organized and comprehensive summary of a product, analytical and customer data associated with a pharmaceutical product
A.R. 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 state of control prior to the request for evidence.
Procedure : All the batches of a product manufactured in a financial year shall be considered while preparing the APR. 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 APR for that year.
The APRs 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 APR, CAPA shall be initiated within 06 month after the end of the financial year, if required and as per SOP titled “Quality Management Review”.
Officer / Executive, QA preparing the APR 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 results, deviations and trends, etc.
The data shall be collected from the records and recorded in the format Annual Product Review against the relevant points.
Product Description: 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 product shall be included.
Time period covered: This shall include all batches manufactured or disposition (released or rejected) during a financial year i.e. from April to March next year.
Manufacturing and testing procedures followed for the product
Technical direction (Manufacturing): A record of Master Formula No. used for batches included in APR shall be given by Officer / Executive-QA. If there is any change in Master Formula No. then the reason for change along with change control reference no. shall be mentioned.
Technical Direction (Packaging): A record of Packaging Formula No. used for batches included in APR shall be given by Officer / Executive-QA. If there is any change in Packaging 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 number shall be given for reviewed batches. If there is any change in Specification or testing procedure, the reason for change(s) along with change control reference no. shall be mentioned in APR.
Finished Product Results: Summary of finished product results of all the batches considered while preparing the APR shall be represented. The trend of the results shall be prepared and presented suitably. Conclusion and recommendations, if any, shall be documented as annexure to the APR.
Tablets Finished Product: average weight of tablets, disintegration time, assay, yield or any other relevant test shall be considered.
Capsules (hard gelatin and soft gelatin) Finished Product: average weight of capsules, disintegration time, assay, yield or any other relevant test shall be considered.
Liquid Oral/Ointment/Gel Finished Product: pH, weight per ml, viscosity, assay, yield or any other relevant test shall be considered.
In-Process Results: Summary of in-process results of all the batches considered while preparing the APR shall be represented. The trend of the results shall be prepared and presented suitably. Conclusion and recommendations, if any, shall be documented as annexure to the APR.
Tablets in-process: LOD, assay and yield but may not be restricted to these parameters only.
Capsules (hard gelatin and soft gelatin) in-process: LOD, water content 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.
Environmental conditions during manufacturing operation: The data of environmental conditions during the manufacturing of all batches shall be reviewed and recorded in the APR.
Critical Equipment performance: The critical equipment’s used during the manufacturing of product shall be identified and overall performance of these equipment’s shall be evaluated by reviewing the breakdown and preventative maintenance records. The observations shall be recorded in the APR.
Process Deviations / Change controls: All product or process deviations, investigations conducted for deviations or change control for change in procedure or product parameters shall be recorded. Any corrective actions derived from these changes and effect of these changes on product quality shall be summarized.
Out of Specification and Out of trend: All the cases of out of specification for 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 cited in the APR.
Non Conformance Report: All details of non-conformance report generated in the respective financial year for particular product shall be mentioned (if any) in the Annual Product 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 name of ingredient, manufacturer/supplier name and address, number of consignments received, number of consignments approved, number of consignments rejected with cause of rejection (if any).
Raw material (API) Manufacturer / Supplier Performance review: The review of 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 and recommendations drawn from the APR shall be recorded.
Wherever applicable, related statistical analysis shall be performed.
Record the observations and inferences on the analysis of data in the format given in Observations and Inference.
All pages of the APR shall have the logo of the company, printed at the top left corner.
The brand name, if any, and generic name and label claim of the product shall also be mentioned in the Annexure-1 titled ‘Annual Product Review’.
All pages shall be compiled and numbered properly.
A cover page shall be prepared giving the Product name, year of review, along with location of manufacture of product.
A summary statement shall be made a part of APR at the start of the document and shall be prepared to provide an overview of entire APR and any key observations made.