Glossary
Harm
Damage to health, including the damage that can occur from loss of product quality or availability.
Source · ICH Q9(R1) (2022), §7 Definitions: Harm
Details
Harm is distinct from the hazard itself and connects the risk question to the consequences for the actual patient or user. Inspections may cite a quality defect assessed only in technical terms, without considering patient exposure, route of administration, or the effect of a supply interruption. Check the harm scenarios, information on the patient and on how the product is used, the basis for the severity rating, and complaint, adverse event, and supply data.
Related sections
Related terms
Real inspection findings
Findings from regulators' inspection documents in which this term appears.
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Your firm manufactures active pharmaceutical ingredients and sterile injectable drug products.
FDA · FDA Warning Letter · 2026-07-14 -
Your firm failed to test incoming active pharmaceutical ingredients (APIs) (e.g.
FDA · FDA Warning Letter · 2026-06-09 -
Legacy Pharmaceuticals Switzerland GmbH has filed for insolvency early December 2020 and is closed.
EMA · EU GMP NCR (EudraGMDP) · 2020-09-30
Counted as of 2026-09-24 — the search you land on shows today's figures, so it may differ slightly.
Source
ICH Q9(R1) (2022), §7 Definitions: HarmGRM Regulatory Glossary
243 GMP terms in one place
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