The annual product quality review (APQR, or PQR in EU terms) confirms that each product’s process is consistent and its specifications are still appropriate. It is required by EU GMP Chapter 1, 21 CFR 211.180(e) and Revised Schedule M. The work is rarely the analysis — it is collecting a year of batches, results, deviations, changes, complaints and stability data from different places.
What the outline covers
- Batches manufactured, released, rejected and reprocessed.
- Starting and packaging materials, especially new sources.
- In-process and finished-product results and trends; OOS.
- Deviations, CAPA effectiveness and changes.
- Regulatory variations, stability results, complaints, returns and recalls.
- Equipment and utilities qualification status and technical agreements.
- Conclusions, recommendations, actions and approvals.