Day: June 11, 2020

Cleaning and Cross-Contamination Case Study

Cleaning and Cross-contamination Issues with an Encapsulator: CGMP Inspection Case Study by FDA National Drug Expert Ileana Barreto-Pettit

At the International GMP Conference at the University of Georgia in Athens, Georgia, in early March 2020 co-sponsored by FDA, FDA Office of Regulatory Affairs National Drug Expert Captain Ileana Barreto-Pettit presented FDA drug GMP warning letter trends over recent years and provided in-depth case studies from Current Good Manufacturing Practice (CGMP) inspections. This first study, presented here, focuses on cleaning and cross-contamination issues with an encapsulator.

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