An annual product quality review (APQR) — called a product quality review (PQR) in EU GMP and an annual product review in US regulations — is a regular, documented review of every licensed product. It looks back over the review period at batch results, deviations and their investigations, OOS results, CAPAs, changes, complaints, returns and recalls, stability data and the status of equipment and supplier qualification.
The purpose is to verify that the process remains consistent and the specifications remain appropriate, and to identify trends and opportunities for improvement. The review ends with conclusions and actions, approved by QA.
Why it matters in GMP
21 CFR 211.180(e) requires written records to be reviewed at least annually to evaluate the quality standards of each drug product. EU GMP Chapter 1 requires regular periodic or rolling quality reviews, and Revised Schedule M in India also requires product quality reviews. Inspectors often use the APQR as a map of a product’s problems, so gaps or inconsistent figures draw attention.
- Collect figures from the actual records, not from manual tallies.
- Freeze the data used, so the review can be reproduced.
- Turn conclusions into tracked actions.
How Swat iQua Suite handles it
Swat iQua Suite’s product quality review collects batch, deviation, CAPA, OOS, change control, environmental monitoring excursion and quality event figures for the review period directly from the system, and freezes them as a snapshot that cannot be changed. The review then goes through preparation and e-signed approval by someone other than the preparer, and produces a controlled PDF report.