Glossary
Product Quality Review (PQR)
Also writtenannual product review
A quality review performed periodically to confirm the consistency of the process and product, the adequacy of specifications, trends, and the need for improvement.
Source · PIC/S PE 009-17, Part I, Chapter 1, Product Quality Review
Related sections
Related terms
Real inspection findings
Findings from regulators' inspection documents in which this term appears.
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Your firm failed to conduct an annual product quality review of your API.
FDA · FDA 483 · 2026-07-10 -
The firm does not perform identification ofunknown degradation products and impurities for products that are listed under product quality review program.
FDA · FDA 483 · 2024-01-17 -
The responsibilities for annual product quality reviews were not adequately addressed in the agreement between each party involved.
HC · Health Canada Inspection · 2022-12-01
Counted as of 2026-09-24 — the search you land on shows today's figures, so it may differ slightly.
Source
PIC/S PE 009-17, Part I, Chapter 1, Product Quality ReviewGRM Regulatory Glossary
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