Audit Readiness for EMA Biologics Inspections
Audit Readiness for EMA Biologics Inspections Ensuring Audit Readiness for EMA Biologics Inspections Biologics manufacturing—ranging from monoclonal antibodies to vaccines and advanced therapy medicinal products (ATMPs)—is governed by some of the most stringent Good Manufacturing Practice (GMP) expectations in the pharmaceutical industry. European regulators, including the European Medicines Agency (EMA), conduct specialized GMP inspections of…