Home » FDA to Give General GMP Guidance on Cross-Contamination
FDA to Give General GMP Guidance on Cross-Contamination
Manufacturers will get the FDA’s first general draft guidance on cross-contamination this year, the Center for Drug Evaluation and Research’s
Office of Compliance said.
Industry experts would like the draft to include advice on maximum allowable levels of a contaminant that can remain on equipment after cleaning and before a new batch is processed.
A process to prevent cross-contamination should set an acceptable level for patient tolerance of a contaminant, which is usually based on toxicological
safety studies with an added safety margin, Rich Yeaton, founder of East Coast Validation Services, said.
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