Glossary
Change Control
A formal system in which representatives of the relevant disciplines review and approve changes that could affect the validated state.
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 -
2 major deficiencies were found in the Quality Management - system of deviations and change control was not established.
EMA · EU GMP NCR (EudraGMDP) · 2019-11-22
