At the International GMP Conference held virtually in March 2022 and co-sponsored by the University of Georgia at Athens and FDA, FDA Office of Regulatory Affairs National Drug Expert Captain, Ileana Barreto-Pettit, presented in-depth case studies from recent drug GMP inspections that illustrate agency findings and concerns.

In a four-part series of articles, Redica Systems Senior GMP Quality Expert Jerry Chapman dove into each case study presented, including an in-depth analysis of the findings, lessons learned, and how companies can avoid similar shortcomings.

Areas examined in the case studies are:

• Inadequate change management systems
• Cross-contamination in solid oral dosage facilities
• Inadequacies and potential contamination hazards in aseptic manufacturing
• Perforated tables and work surfaces in cleanrooms

Download all 4 Case Studies in a Compiled Report

Easily read and share all four case studies by downloading the compiled report by Jerry Chapman. Click here for this FREE instant download.