Glossary
Risk
The combination of the probability of harm occurring and the severity of that harm.
Source · ICH Q9(R1), Glossary, Risk
Related sections
Related terms
Real inspection findings
Findings from regulators' inspection documents in which this term appears.
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You failed to adequately test each shipment of each lot of propylene glycol for identity, a component at higher risk for diethylene glycol (DEG) and ethylene glycol (EG) contamination.
FDA · FDA Warning Letter · 2024-09-24 -
For example, your firm failed to adequately test each shipment of each lot of incoming components at high-risk of diethylene glycol (DEG)…
FDA · FDA Warning Letter · 2024-04-16 -
There are currently no tests that can evaluate a donor’s risk for CJD or xenotransplantation.
FDA · FDA Warning Letter · 2024-10-22
Counted as of 2026-09-24 — the search you land on shows today's figures, so it may differ slightly.
Source
ICH Q9(R1), Glossary, RiskGRM Regulatory Glossary
243 GMP terms in one place
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