FDA Drug Manufacturing Inspections Guidelines

I - BACKGROUND

Until 2012, FDA was required to inspect domestic establishments that manufacture drugs marketed in the United States every 2 years, but there was no comparable requirement for inspecting foreign establishments. The Food and Drug Administration Safety and Innovation Act (FDASIA),5 which amended the FD&C Act section 510(h), eliminated this distinction, directing FDA to take a risk based approach to inspecting both domestic and foreign drug manufacturing establishments. The selection of both domestic and foreign establishments for routine surveillance inspections is now driven by a risk-based site selection model. In 2015 the agency formalized its process for selecting establishments for inspection based on risk factors specified by section 510(h) of the Act.

This compliance program provides surveillance inspection coverage of drug manufacturing establishments complying with the requirements of CGMP as per 501(a)(2)(B) of the Act and implementing regulations. The focus of surveillance inspections is on system-wide controls that ensure manufacturing processes produce quality drugs. Systems examined during these inspections include those related to materials, quality control, production, facilities and equipment, packaging and labeling, and laboratory controls.

FDA expects that establishments that comply with CGMP are likely to operate in a state of control and consistently manufacture drug products of acceptable quality. FDA will use information gathered from surveillance inspections to, among other things, make assessments about manufacturing facilities listed in pending drug applications.

The inspectional guidance in this program is structured to provide for efficient use of resources devoted to routine surveillance coverage, recognizing that in-depth coverage of all systems and all processes is not feasible or required for all firms and inspections.

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FDA Drug Manufacturing Inspections Guidelines

FDA Drug Manufacturing Inspections Guidelines: