Contaminants
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. (Reference: ICH Q6B).
Contamination
The undesired introduction of impurities of a chemical or microbiological nature, or of foreign matter, into or onto a raw material, intermediate, or Active Pharmaceutical Ingredient (API) during production, sampling, packaging or repackaging, storage or transport.
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