FDA to Issue First General Guidance on Cross-Contamination

Manufacturers will get the FDA’s first general draft guidance on cross-contamination this year, as well as final guidances on process validation and mechanical calibration of dissolution apparatuses. The cross-contamination draft guidance would cover preventive measures and controls in manufacturing or handling more than one substance in a facility, Brian Hasselbalch and Steven Wolfgang of CDER’s Office of Compliance said. Rich Yeaton, founder of East Coast Validation Services, said the draft could give industry much-needed advice on maximum allowable levels of a contaminant that can remain on equipment after cleaning.
Drug Industry Daily