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Sterile manufacturing operations remain one of the highest risk pharmaceutical processes. This talk will include a discussion of recent cases and causes of media fill failures and positive sterility tests and will illustrate the critical role of a robust and meaningful environmental monitoring program in all aseptic processes, ranging from older processing lines to modern isolators. We will also examine examples of the careful and precise steps to ensure the quality of aseptically produces drug products and discuss the need for a strong sterility assurance program and quality system to support parametric release of terminally sterilized products.
Speaker(s):
Brooke
Higgins,
Senior Policy Advisor for the Global Compliance Branch 3,
FDA/CDER
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