Annexure – I for Anual product quality Review

                              Annual Product Quality Review Report

1. Product Description
   1. Product Name:
   2. Generic Name:
   3. Label Claim:
   4. Strength:
   5. Packaging Types Available:
   6. M.F. Nos.
   7. Batch sizes available:
   8. Markets
   9. Shelf Life
   10. Indications
2. Time Period Covered for APR
   1. ___________________ to ______________________
   2. Batches Manufactured: Batch Number _____________ to _____________
3. Manufacturing and testing procedures followed
   1. Technical direction (Manufacturing)
   2. Technical Direction (Packaging)
   3. Specifications / STP (In-process)
   4. Specifications / STP (Finished Product)
   5. Specifications / STP (Packaging component)
4. Finished Product Results
5. In-Process Results
6. Environmental conditions during manufacturing operation
7. Critical Equipment performance
8. Process Deviations / Change controls
9. Out of Specification and Out of trend
10. Non Conformance Report
11. Product complaints
12. Returned goods or recalled products
13. Yield reconciliation
14. Adverse drug reactions
15. Active Pharmaceutical Ingredient data
16. Raw material (API) Manufacturer / Supplier Performance review

 

Name of API	Manufacturer (Name and Address)	Supplier (Name and Address)	Consignment / Batches  Received	Consignments Approved	Consignments Rejected	Cause of Rejection

 

Conclusions and recommendations:

 

 

 

 

Prepared By	Checked By	Approved By
Sign / Date	Sign / Date	Sign / Date	Sign / Date

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