Glossary
Good Manufacturing Practice (GMP)
Also writtencGMPcurrent good manufacturing practice
The part of quality assurance ensuring that medicines are consistently produced and controlled to the quality standards appropriate to their intended use.
Details
GMP is not a way of confirming quality by testing alone; it is the minimum operating system that designs and controls people, facilities, processes, records, and release so that product is made consistently. In inspections, the gap between the approved procedure and what is actually done, weak quality unit oversight, and incomplete data and batch records are what turn into system level findings. Look at the quality manual, the organisation and its responsibilities, manufacturing and testing records, deviations, CAPA and change control, and the release approval evidence together.
Related sections
Related terms
Real inspection findings
Findings from regulators' inspection documents in which this term appears.
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FDA investigators observed multiple documents related to CGMP activities that had not been completed, such as: CGMP-related policies…
FDA · FDA Warning Letter · 2023-08-01 -
Outsourcing facilities must comply with CGMP requirements under section 501(a)(2)(B) of the FDCA…
FDA · FDA Warning Letter · 2024-05-14 -
Outsourcing facilities must comply with CGMP requirements under section 501(a)(2)(B) of the FD&C Act.
FDA · FDA Warning Letter · 2025-07-03
Counted as of 2026-09-24 — the search you land on shows today's figures, so it may differ slightly.
Source
WHO Technical Report Series No. 986, Annex 2, WHO good manufacturing practices for pharmaceutical products: main principles, GlossaryGRM Regulatory Glossary
243 GMP terms in one place
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