Cleaning validation is driven by regulatory requirements to ensure that residues from one product will not carry over and
cross contaminate the next product. The cleaning program consists of equipment design and qualification, a cleanability study,
sampling evaluation, and meeting predetermined acceptance criteria. Dirty and clean hold times are established during cleaning
validation. Cleaning validation is supported by approved procedures, training, change control, monitoring, and revalidation.
A cleaning validation strategy that is based on the evaluation of potential risks increases success rate and reduces execution
The author is thankful to Lara Collier for management support and to Jenna Carlson and Ahmed Bassyouni for reviewing the manuscript
and providing comments.
A. Hamid Mollah, PhD, is a senior technical manager for corporate quality and validation at Genentech, Inc., South San Francisco, CA, 650.467.1095,
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