Europe issues draft guidance on cross-contamination thresholds

01/18/2013 | In-PharmaTechnologist.com

Cross-contamination thresholds should be identified when more than one drug is made in the same production facility, the European Medicines Agency said in a draft guidance. Companies should know the threshold of toxicological concern or the permitted daily exposure by evaluating the available data from patient trials and laboratory tests. Treatments such as cytotoxic and highly active drugs, hormones and antibiotics must be produced separately.

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