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Manufacturers will get the FDA’s first general draft guidance on cross-contamination this year, the Center for Drug Evaluation and Research’s Office of Compliance said.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.
Drug GMP Report