www.fdanews.com/articles/123953-fda-to-issue-first-general-guidance-on-cross-contamination
FDA to Issue First General Guidance on Cross-Contamination
January 25, 2010
Manufacturers will get the FDA’s first general draft guidance on cross-contamination this year, as well as final guidances on process validation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 The cross-contamination draft guidance would cover preventive measures and controls in manufacturing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
Drug Industry Daily