Glossary
Change Management
A systematic approach to proposing, evaluating, approving, implementing, and reviewing changes.
Source · ICH Q10, Glossary, Change Management; MFDS, 「알기 쉬운 GMP 용어집」 Korean original
Related sections
Related terms
Real inspection findings
Findings from regulators' inspection documents in which this term appears.
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Your firm made changes to your manufacturing process parameters in the batch manufacturing instructions without following your Procedure for Change Management and Operational Procedures for Handling of Abnormal Situations .
FDA · FDA Warning Letter · 2026-10-06 -
For example, you changed the manufacturing process for (b)(4) to rephase the formulation without revalidation and outside of your change management system.
FDA · FDA Warning Letter · 2026-09-29 -
Your firm’s quality unit failed to have procedures for GMP training, handling OOS results, and change management.
FDA · FDA Warning Letter · 2025-03-04
Counted as of 2026-09-24 — the search you land on shows today's figures, so it may differ slightly.
Source
ICH Q10, Glossary, Change Management; MFDS, 「알기 쉬운 GMP 용어집」 Korean originalGRM Regulatory Glossary
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