SOP for Annual Product Review (Product Quality Review)
1.0 OBJECTIVE:
This procedure provides instruction for the development of all Annual product reviews (APRs) also known as product quality review for all pharmaceutical products included, in this procedure are direction for the contents, organization, timing, review, action items and Approvals of APRs.
2.0 SCOPE:
This procedure applies to all pharmaceutical products manufactured, packaged, or tested during any annual time period. The validation summary of those batches manufactured for Optimization, Qualification and Exhibit to be included in Product Quality Review.
3.0 RESPONSIBILITY:
3.1 Quality Assurance : To compile the data for APR and to prepare the APR.
3.2 Production : To review the data.
3.2 Head – Quality Assurance Department : To approve the APR and to ensure compliance.
Reference Document: (1) EU Guideline on GMP of Product Quality review.
(2) 21 CFR Part 211.180(e)
4.0 PROCEDURE:
4.1 Product Quality Review for a product shall be completed within two month of the calendar year.
4.2 The Product Quality Review report shall be prepared by APR Coordinator, reviewed by Head of production / Designee and approved by Head Quality Assurance / Designee.
4.3 Summary of Optimization, Qualification and Exhibit shall be reviewed in Product Quality Review.
4.4 The following Data or information will be collected, summarized and reviewed.
4.4.1 Product Details shall be as follows.
4.4.1.1 Product name
4.4.1.2 Product Code
4.4.1.3 Shelf Life
4.4.1.4 Period of review
4.4.2 Summary Report
4.4.3 Starting Material and Packing Material form new sources
4.4.4 Process Parameters
4.4.5 In-process Analytical data
4.4.6 Finished Product Analytical data
4.4.7 The Yield data
4.4.8 Evaluation of Batch Data
4.4.9 Deviations / Incidents or Non conformance (NCR)
4.4.10 Change Control Proposals
4.4.11 Out Of Specification (OOS)
4.4.12 Stability Study Data
4.4.13 Control Sample (Also called as Retained Sample or Reserve Sample)
4.4.14 All Market Complaints, Product recalls, Product returns or Salvaged goods
4.4.15 Process Re-validation and Equipment Qualification
4.4.16 Environment Monitoring
4.4.17 Inspection from Official Inspectorate for / related to product
4.4.18 Batches Reworked / Reprocessed/ Batch Failure
4.4.19 Recommendation from previous Product Quality Review
4.4.20 Technical Agreements
4.4.21 Marketing Authorization Variation and Post Marketing Commitments
4.4.22 Post Marketing Commitment for New Marketing Authorization
4.4.23 Regulatory Correspondences
4.4.24 Corrective Action and Conclusion
4.5 Each set of data will be tabulated and/or graphed in such a fashion so as to easily exhibit results, Deviations and trends.
4.6 The APR Coordinator will generate an overall APR summary that will comprise the following.
4.6.1 Narrative summary of each section or reference to individual section.
4.6.2 Quality issues or deviations identified by the section summaries.
4.6.3 Recommendations and action plans to address issues.
4.6.4 Status of any action plans from previous APRs for this Product.
4.6.5 A Statement indicating the conclusion of the individual APR as defined by one of the following
4.6.5.1 Process In Control – This conclusion indicates no abnormalities within sets of data and confirms that the process continues to function as validated
4.6.5.2 Actions recommended – This conclusion Indicates that some recommended actions should be considered, but the process is essentially functioning as designed and validated – the process continues to operate In a state-of-control.
4.6.5.3 Corrective actions required – This conclusion indicates the need for Immediate actions or corrections – the process is not operating in a state-of-control, and an investigation is required that includes evaluating the impact on marketed product .
4.7 The completed APR, including each section summary and the overall APR summary with recommendations, will be reviewed and approved by the following
4.7.1 APR Coordinator
4.7.2 Production Head
4.7.3 Head Quality Assurance.
4.8 Record – The original Copy will be Kept by APR Coordinator.
4.9 Record Distribution – copies of the completed and approved APR Will be forwarded to the production Head, quality control, Quality assurance, R&D, CQA and Department / Individuals responsible for corrective actions.
ANNEXURES:
Annexure I – Content Of annual Product review
01. Product Details
02. Summary Report
03. Review of Starting Material and Packing Material From New sources
04. Review of Process Parameters (Manufacturing and Primary packing)
05. Review of In-Process Analytical Data
06. Review of Finished Product Analytical Data
07. Review of Yield Data
08. Review of Evaluation of Batch Data
09. Review of Deviations / Deviation or Non Conformances (NCR)
10. Review of Change Control Proposals
11. Review of Out of Specification (OOS)
12. Review of Stability Study Data
13. Review of Control Samples
14. Review of Market Complaint, Product Recall, Product Return or Salvaged Goods
15. Review of Process Revalidation and Equipment Qualification
16. Review of Environment Monitoring
17. Review of Inspection from Official Inspectorate for / related to product.
18. Review of Batches Reworked / Reprocessed / Batch Failure:
19. Review of recommendation from Previous Product Quality Review
20. Review of Technical Agreement
21. Review of Marketing Authorization Variation and Post Marketing Commitments
22. Review of Post Marketing Commitments for New Marketing Authorization
23. Regulatory Correspondences
24. Corrective Action and Conclusion