Glossary
Record
A document or data providing evidence of an activity performed or a result obtained.
Source · WHO TRS 986 Annex 2, §15 Documentation; PIC/S PE 009-17 Part I, Chapter 4
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 firm could not provide records that process performance…
FDA · FDA Warning Letter · 2024-12-17 -
Your response to our request for records and other information under section 704(a)(4) indicates that you…
FDA · FDA Warning Letter · 2021-03-16 -
Based on the records and information provided, you did not demonstrate that you adequately tested your finished drug products prior to release and distribution.
FDA · FDA Warning Letter · 2024-11-26
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 Documentation; PIC/S PE 009-17 Part I, Chapter 4GRM 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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