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.
Related sections
Related terms
Real inspection findings
Findings from regulators' inspection documents in which this term appears.
-
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
