Glossary
Documentation
The GMP system of preparing, approving, and controlling specifications, procedures, records, and reports so that activities and decisions are evidenced.
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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Furthermore, your response did not include documentation of any new smoke studies conducted since March 2020.
FDA · FDA Warning Letter · 2021-07-27 -
However, there is no documentation that the responsible physician approved the reinstatement of this donor into the plasmapheresis program as required.
FDA · FDA Warning Letter · 2024-10-15 -
No supporting documentation was provided to determine how the audits will be conducted (in person vs.
FDA · FDA Warning Letter · 2023-05-30
