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Life-Sciences eQMS 21 items

Annual Product Quality Review (APQR/PQR) Checklist

Structures the periodic (typically annual) review of a product's manufacturing and quality data to verify process consistency and identify improvements. Use to compile and approve the yearly product quality review.

21 CFR 211.180(e)ICH Q7EU GMP Annex / Chapter 1

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Scope and Data Sources

  • Does the review cover all batches manufactured within the defined review period? *
  • Record the review period start and end dates.
  • Record the number of batches manufactured, released, and rejected during the period.
  • Are all relevant data sources (production, QC, QA systems) identified and reconciled? *

Materials and Suppliers

  • Are results of starting materials and packaging components, especially from new sources, reviewed? *
  • Are changes to material suppliers evaluated for quality impact? *
  • Are critical raw material trends (e.g., rejections) summarized? *

In-Process and Finished Product Results

  • Are critical in-process control and finished product test results trended across the period? *
  • Are all OOS and out-of-trend results reviewed with their investigations? *
  • Is process capability assessed against specifications where applicable? *
  • Attach or reference the trend charts supporting the review.

Deviations, Complaints, and Recalls

  • Are all deviations and their investigations for the period reviewed for trends? *
  • Are product complaints, returns, and any recalls reviewed and trended? *
  • Are rejected and reprocessed/reworked batches reviewed? *

Changes, Stability, and Validation Status

  • Are all change controls (process, method, equipment, specification) executed in the period reviewed? *
  • Are stability program results and any adverse trends reviewed? *
  • Is the qualification/validation status of relevant equipment, utilities, and methods confirmed as current? *

Conclusions and Actions

  • Does the review conclude whether the process and controls remain in a state of control? *
  • Are recommended CAPAs, revalidation needs, or improvements documented with owners? *
  • Is the completed APQR approved by the quality unit? *
  • Quality unit approval sign-off. *

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