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GMP - FDA Third Party Inspections

The U.S. Food and Drug Administration (FDA) has authorized TUV Rheinland of North America, Inc. to perform independent inspections of medical device manufacturers for compliance with Good Manufacturing Practices (GMP) and other applicable requirements.

This new inspection by Accredited Person Program (AP Program) was established according to the Medical Device User Fee and Modernization Act of 2002 (MDUFMA) and is intended to reduce the need of multiple inspections of the same manufacturer establishments and also allow the FDA to better focus their resources.

Under the AP Program, eligible manufacturers of class II or class III medical devices may elect to have third parties, such as TUV Rheinland of North America, conduct their inspections instead of the FDA.

The benefits for manufacturers to request an inspection by an Accredited Person (AP) include:

• Inspections by an AP may cover the requirements of more than one regulatory authority. TUV Rheinland of North America, for example, is able to offer combination inspections to cover the regulatory requirements of the European Community (MDD, AIMD, IVDD), Canada (CMDR), Japan (PAL) and the U.S. (GMP). By utilizing an AP manufacturers can reduce disruptions of their normal operation and save time, resources and money.
• The AP Program allows manufacturers greater control over the timing of their inspections. Inspections are announced and planned well in advance and manufacturers are allowed to request the date of the inspection.
• Not all registered establishments are inspected in a two year interval as required by statutes. However, statistics show, that regularly inspected establishments are more likely to be found in compliance with the regulations. By requesting an AP inspection on a regular basis, manufacturers can increase their confidence in their quality management system and its conformance to the U.S. regulations.

The AP Program is open to domestic U.S. device establishments, as well as foreign establishments that are required to register with FDA. Manufacturer's participation in the program is voluntary. Establishments must satisfy several criteria in order to be eligible to participate in the AP program. The FDA guidance document which details the criteria can be found at here. TUV Rheinland has summarized the criteria below

What are the Eligibility Requirements for Participating in the AP Inspection Program?

• You manufacture a class II or class III medical device
• You market at least one of the device in the United States
• You market or intend to market at least one of the devices in one or more foreign countries, which either recognize inspections by the selected AP or inspections by the FDA
• Your most recent inspection performed by FDA, or by an AP under this program was classified as "No action indicated (NAI)" or "Voluntary Action Indicated (VAI)"
• You submitted a notice to FDA requesting clearance to use an AP.

For additional information please contact us.

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