Glossary
Change Management
A systematic approach to proposing, evaluating, approving, implementing, and reviewing changes.
Related sections
Related terms
Real inspection findings
Findings from regulators' inspection documents in which this term appears.
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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 -
Your firm failed to have an adequate change management program to evaluate and approve changes that may impact the quality of the excipient.
FDA · FDA Warning Letter · 2022-12-20
