Annual Product Quality Review (APQR | PQR | APR) is a regulatory requirement for pharma companies.
Annual Product Quality Review (APQR | PQR | APR) guidelines
Requirements of APRs are found in 21 CFR part 211.180 (e) and include :
Written records required by this part shall be maintained so that data therein can be used for evaluating, at least annually, the quality standards of each drug product to determine the need for changes in drug product specifications or manufacturing or control procedures.
Written procedures shall be established and followed for such evaluations and shall include provisions for :
(1) A review of a representative number of batches, whether approved or rejected, and, where applicable, records associated with the batch.
(2) A review of complaints, recalls, returned or salvaged drug products, and investigations conducted under part 211 – 192 for each drug product.
- Procedure
- Review every batch manufacturing records (BMR) to determine the need for changes in specification or manufacturing or control procedures
- Review of complaints
- Review of recalls
- Review of returned and salvaged products
- Review of investigations