MICROBIOLOGICAL CGMP REQUIREMENTS FOR THE NON-STERILE AND ASEPTIC FILL ‘N FINISH ENVIRONMENT
July 11, 2019 | (10.30)
USA (United States of America)
As a product proceeds through manufacturing to the API with the addition of various excipients, both non-sterile and sterile products (aseptic fill ‘n finish) must be tested for their microbiological content. With non-sterile products, a limited number of microorganisms are acceptable; with sterile products, no microorganisms may be present. Often issues of OOT, OOS and CAPAs become critical at this juncture point. Quality Metrics and their Risk Based implications of deviation related issues will be considered for both non-sterile and aseptically produced products.