The FDA Drug Product Application Review Process: Microbiological Considerations
Posted on January 27, 2014
By: Steven Donald, Product Quality Microbiology Reviewer
FDA
Introduction The FDA Product Quality Microbiology reviewer frequently encounters common problems or omissions in new drug application submissions that frequently lead to subsequent information request and ultimately delay completion of the microbiology review. This is particularly true for sterile ...
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Related Topics and Keywords
aseptic filling, Container and Closure Integrity, critical control points (CCPs), endotoxin, FDA, Media Fill, microbiology, sterilisation validation
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