Annual Product Quality Review (APQR / PQR)

Annual product quality review shall be evaluated and recorded, annually for specific drug substance or drug product to verifying the consistency of the manufacturing process.  

The APQR / PQR shall have minimum following content:

1. A review of key starting material quality and its vendor for product
2. A review of packaging materials quality and its vendor for product
3. A review of critical in-process control of API and its intermediate
4. A review of critical process parameters of API and its intermediate
5. A review of all batches that failed to meet established specifications
6. A review of quality attributes of all finished product batches
7. A review of all critical deviations
8. A review of OOS (Out-of-Specification) batches quality and related investigation
9. A review of product specific changes carried out in specification, system, manufacturing records, analytical method, validation etc
10. A review of stability results (annual and validation batches);
11. A review of all quality-related returns goods
12. A review of all, complaints and recalls
13. A review of adequacy of corrective actions and preventive actions taken for complaint, recall, return goods etc.

The results of this review are evaluated and assessment made of whether corrective action or any revalidation shall be taken for product. Reason for corrective action and documentation And actions are completed in a timely and effective manner.