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- W2912145792 abstract "This chapter discusses establishment inspections that the Food and Drug Administration (FDA) conducts in order to verify manufacturing data associated with a new drug application (NDA) or abbreviated new drug application, and determines whether the manufacturer of the product is in compliance with current good manufacturing practice requirements. The program extends to domestic and foreign manufacturers and may cover the manufacture of active pharmaceutical ingredients (APIs), finished drug product manufacturing, and control testing laboratories. The FDA’s preparations for a pre-approval inspection include scheduling the inspection, choosing the inspection team, and conducting a pre-inspection review of available information. The FDA will evaluate whether an establishment’s quality system is sufficiently robust to achieve sufficient control over the facility and commercial manufacturing operations. For manufacturing operations, the investigator reviews everything from the equipment to processing lines." @default.
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- W2912145792 date "2019-02-04" @default.
- W2912145792 modified "2023-09-23" @default.
- W2912145792 title "FDA Pre-approval Inspections" @default.
- W2912145792 doi "https://doi.org/10.1201/9781315120669-22" @default.
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