Glossary
Documentation
The GMP system of preparing, approving, and controlling specifications, procedures, records, and reports so that activities and decisions are evidenced.
Source · WHO TRS 986 Annex 2, §15 Documentation
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
Counted as of 2026-09-24 — the search you land on shows today's figures, so it may differ slightly.
Source
WHO TRS 986 Annex 2, §15 DocumentationGRM Regulatory Glossary
243 GMP terms in one place
Each term is explained in plain language with its official source. Look it up here whenever you meet a term you don't know.
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