Walkthrough of a Pre-Approval Manufacturing Site Inspection (14of14) REdI 2018

FDA’s Office of Regulatory Affairs’ Lucila B. Nwatu describes the general inspectional approach for FDA pre-approval inspection of sterile and biological therapeutic drug products. She includes the requirements to demonstrate the ability to operate in compliance with cGMPs, adherence to application commitments, and authenticity and accuracy of data submitted in applications.
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