Glossary
Hazard
A potential source of harm to human health or to product quality.
Source · ICH Q9(R1), Glossary, Hazard
Related sections
Related terms
Real inspection findings
Findings from regulators' inspection documents in which this term appears.
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Your response did not provide sufficient detail for an evaluation of your corrections related to the handling of hazardous drugs to prevent cross contamination.
FDA · FDA Warning Letter · 2021-11-16 -
Your aseptic manufacturing process should be designed, and operations should be executed to minimize contamination hazards to your sterile drug product.
FDA · FDA Warning Letter · 2025-03-11 -
In your April 6, 2020 response to Observation 14 of the Form FDA 483, you stated that you have segregated all hazardous drug products and are working with a third-party vendor to develop procedures and to obtain a deactivation agent.
FDA · FDA Warning Letter · 2021-10-05
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, HazardGRM Regulatory Glossary
243 GMP terms in one place
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