Glossary
Product Quality Review (PQR)
A quality review performed periodically to confirm the consistency of the process and product, the adequacy of specifications, trends, and the need for improvement.
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
