Glossary
Procedure(s)
A document describing the operations, precautions, and measures directly or indirectly related to the manufacture of a medicine.
Source · MFDS, 「알기 쉬운 GMP 용어집」, Procedure(s) Korean original
Related sections
EU GMP Part I Chapter 4 21 CFR 211.180–211.194
Related terms
Real inspection findings
Findings from regulators' inspection documents in which this term appears.
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Failure to establish adequate written procedures for production and process control designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess, as required by 21 CFR 211.100(a).
FDA · FDA Warning Letter · 2026-09-22 -
For example, your QU failed to ensure the following: • Establishment of adequate procedures describing the QU’s responsibilities (21 CFR…
FDA · FDA Warning Letter · 2024-08-13 -
For example, your QU failed to ensure: Establishment of procedures describing roles and responsibilities of the…
FDA · FDA Warning Letter · 2025-10-07
Counted as of 2026-09-24 — the search you land on shows today's figures, so it may differ slightly.
Source
MFDS, 「알기 쉬운 GMP 용어집」, Procedure(s) Korean originalGRM Regulatory Glossary
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