Glossary

Deviation

Approved instruction Deviation
Illustration

A departure from an approved instruction or an established standard.

Source · ICH Q7, §20 Glossary, Deviation

Related sections

ICH Q10 §§3.2.2–3.2.3 21 CFR 211.192

Related terms

Corrective and Preventive Action (CAPA)52 casesChange Control523 casesRoot Cause Analysis (RCA)11 cases

Real inspection findings

Findings from regulators' inspection documents in which this term appears.

  1. For example, deviations were not recorded, and investigations were not conducted when microbiological test results were…
    FDA · FDA Warning Letter · 2024-08-06
  2. Our inspection documented approximately 84 open and past due deviation investigations existed as of June 21, 2024.
    FDA · FDA Warning Letter · 2025-01-21
  3. You failed to initiate or conduct adequate investigations into significant deviations in your aseptic processing manufacturing operations.
    FDA · FDA Warning Letter · 2023-11-28
See 952 findings whose text contains this term

Counted as of 2026-09-24 — the search you land on shows today's figures, so it may differ slightly.

Source

ICH Q7, §20 Glossary, Deviation

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