White Paper | December 2, 2013

Tips On Preparing For An FDA Inspection: Are You Following cGMP?

Source: Vaisala, Inc.
PreparingFDAInspection

By Bruce McDuffee, Marketing Manager, Vaisala Life Science Division

If you’re in the business of manufacturing drugs, medical devices, nutraceuticals, manufacturing or importing any product in the United States that must comply with current Good Manufacturing Practice (cGMP), your facility will be inspected by the U.S. Food and Drug Administration (FDA).

According to the Federal Food, Drug and Cosmetic Act, “Registered domestic drug establishments shall be inspected by the FDA at least once every two years.” Under some conditions the inspections may be even more frequent, such as when a drug is being manufactured for the first time, if there have been previous problems validating a similar process, if production of a product or a new process is substantially different from past operations, or when a process is particularly complex.

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