USFDA inspected Global Pharma facility from 20th February to 2nd March 2023; issue 11 observations (FDA 483) Major observations include inadequate Validation of sterilization processes, facility, operators, Lack of sterility assurance of manufacturing processes, Cleaning and disinfection procedures, cleaning methods and cleaning verification, Testing methods & validation, Testing of product components (APIs, Excipients, sterile packing materials), Batch review and batch release procedures. Read More..

Qvents Team

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