CGMP Cleanroom Regulations

How does the FDA guarantee that a company is complying with CGMP regulations?

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The Food and Drug Administration (FDA) inspects pharmaceutical manufacturing facilities and pharmaceutical cleanrooms worldwide, including facilities that manufacture active ingredients and the finished product. The Food and Drug Administration (FDA) conducts careful inspections of regulated facilities to determine a firm’s compliance with regulations and the Food, Drug and Cosmetic Act. Inspections are one of many ways FDA protects the public health.

FDA also relies upon reports of potentially defective drug products from the public and the industry. FDA will often use these reports to identify sites for which an inspection or investigation is needed. Most companies that are inspected are found to be fully compliant with the CGMP regulations.

Inspections are classified (see Inspection Classifications) to reflect the compliance status of a firm. Classifications are based upon findings identified during an inspection and Agency review for compliance. During the Agency assessment, classifications may be subject to change after a review of all relevant information. To maintain current knowledge of a firm’s compliance status, it may be important to recheck the Inspections Database for updates.


Answered on November 13, 2017.
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