contaminants
- Guideline or reference source
- ICHQ11 Development and manufacture of drug substances
- ICHQ6B Test procedures and acceptance criteria for biotechnological/biological products
- Definition
- Any adventitiously introduced materials (e.g., chemical, biochemical, or microbial species) not intended to be part of the manufacturing process of the drug substance or drug product.
- Related Term
- air monitoring
- containment
- contamination
- impurity
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