Advanced Therapies and Biologics in the PIC/S Inspection Model
Advanced Therapies and Biologics in the PIC/S Inspection Model How PIC/S Tailors Inspections for Advanced Therapies and Biologics Biologics and advanced therapy medicinal products (ATMPs) such as gene therapy, cell therapy, and tissue-engineered products are transforming modern medicine. These complex products pose unique Good Manufacturing Practice (GMP) challenges, requiring specialized regulatory oversight. The Pharmaceutical Inspection…
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