Annual Product Review Report Outline

Please share an outline for APR Report.

Your kind recommendation is highly appreciated.

Thank you.

  1. Scope
  2. Manufactured Batches, Batch Record, Yield Review
  3. Change Control Review
  4. Label and Artwork Change Review
  5. Analytical Data Review
  6. Stability Data Review
  7. Validation and Qualification Review
  8. Non-Conformances and LI Review
  9. Rejected Batches Review
  10. Re-Packaged Batches Review
  11. Compliant Review
  12. Field Alert and Recall Review
  13. Retain Sample Review
  14. GMP Agreement
  15. Review of Previous APR
  16. Conclusions and Recommendations
  17. References
  18. Approval

Common Tables and Charts

• Summary of Lot Enumeration for Bulk Batches
• Summary of Lot Enumeration for Finished Product
• Summary of Batch Yield
• Summary of Analytical Results
• Summary of In-Process Results—Encapsulation
• Reserve Sample Annual Inspection
• Summary of Changes
• Description of Deviations and Non-Conformances
• Batches introduced to the Stability Program During Review Period
• On-going Stability Batches introduced Prior to Review Period

[quote=DURGA PRASAD]1. Scope
2. Manufactured Batches, Batch Record, Yield Review
3. Change Control Review
4. Label and Artwork Change Review
5. Analytical Data Review
6. Stability Data Review
7. Validation and Qualification Review
8. Non-Conformances and LI Review
9. Rejected Batches Review
10. Re-Packaged Batches Review
11. Compliant Review
12. Field Alert and Recall Review
13. Retain Sample Review
14. GMP Agreement
15. Review of Previous APR
16. Conclusions and Recommendations
17. References
18. Approval

Common Tables and Charts

• Summary of Lot Enumeration for Bulk Batches
• Summary of Lot Enumeration for Finished Product
• Summary of Batch Yield
• Summary of Analytical Results
• Summary of In-Process Results—Encapsulation
• Reserve Sample Annual Inspection
• Summary of Changes
• Description of Deviations and Non-Conformances
• Batches introduced to the Stability Program During Review Period
• On-going Stability Batches introduced Prior to Review Period[/quote]

Thank you sir. This will guide us in preparing our APR.

Could you share trend analysis template and graphs please? Many thanks!