Glossary
Procedure(s)
A document describing the operations, precautions, and measures directly or indirectly related to the manufacture of a medicine.
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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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 -
Your firm failed to have appropriate procedures for the integration of chromatographic peaks and for the review of chromatographic data processing.
FDA · FDA Warning Letter · 2022-12-06
