contamination
- Guideline or reference source
- ECA GAMP5 Approach and Risk Management
- ICHQ7 Good manufacturing practice for active pharmaceutical ingredients
- WHOGMP Quality assurance of pharmaceuticals volume 2
- Definition
- The undesired introduction of impurities of a chemical or microbiological nature, or of foreign matter, into or onto a raw material, intermediate, or API during production, sampling, packaging or repackaging, storage or transport.
- Narrower Term
- infected
- Related Term
- bioburden
- containment
- contaminants
- cross-contamination
- decontamination
- drug recall
- impurity
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