Annexure – I for Anual product quality Review

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                              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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