Glossary
Change Control
A formal system in which representatives of the relevant disciplines review and approve changes that could affect the validated state.
Source · MFDS, 「알기 쉬운 GMP 용어집」, Change Control; WHO TRS 1019 Annex 3, Glossary Korean original
Related sections
Related terms
Real inspection findings
Findings from regulators' inspection documents in which this term appears.
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For example, your QU failed to: • Follow your change control procedure for drugs shipped to the United States.
FDA · FDA Warning Letter · 2024-12-17 -
You stated that a checklist will be developed under change control CC-HOU-2025-028 and that implementation of routine walkthroughs will provide risk mitigation pending completion of procedural edits.
FDA · FDA Warning Letter · 2025-11-25 -
09 (which introduced immediate failure of a visual inspector for missing any critical defect) through formal change control or a timely requalification plan for previously qualified inspectors that did not meet the new standard.
FDA · FDA Warning Letter · 2026-10-06
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」, Change Control; WHO TRS 1019 Annex 3, Glossary Korean originalGRM Regulatory Glossary
243 GMP terms in one place
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