Glossary
Quality
The degree to which an API or a medicine is suitable for its intended use, including such attributes as identity, strength, and purity.
Source · WHO Quality Assurance of Medicines Terminology Database, Quality
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 establish an adequate quality unit (QU) to adequately oversee the manufacture of your drug products.
FDA · FDA Warning Letter · 2024-09-24 -
As such, you do not have assurance that you are capable of consistently manufacturing an OTC drug product with defined quality…
FDA · FDA Warning Letter · 2024-04-16 -
There is no sufficiently documented and controlled pharmaceutical quality management system.
EMA · EU GMP NCR (EudraGMDP) · 2021-11-12
Counted as of 2026-09-24 — the search you land on shows today's figures, so it may differ slightly.
Source
WHO Quality Assurance of Medicines Terminology Database, QualityGRM Regulatory Glossary
243 GMP terms in one place
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