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U.S. Department of Health and Human Services

Drugs

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Progress Report of the Pharmaceutical Inspectorate Working Group

Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach

Comments on this report or on the activities of this working group should be submitted to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with Docket Number 03N-0059.

Electronic Management Comment Form:  Docket 03N-0059 - Pharmaceutical Current Good Manufacturing Practices for the 21st Century: A Risk-Based Approach

To use our resources in the most effective and efficient manner to ensure a high level of drug product quality, the Food and Drug Administration has decided to develop a specialized team of experts in drug product manufacturing to conduct inspections of high risk firms.

The Pharmaceutical Inspectorate (PI) will consist of highly trained individuals that focus a majority of their time on conducting human and animal drug quality inspections on high risk firms (Note: Preapproval inspections would also be conducted by this staff. The PI would not conduct bioresearch monitoring inspections.) The PI will have a close working relationship with the Center staffs working on ensuring good product quality.

We anticipate that a position description for the PI will be established by June 2003 with the goal of enrolling 15-25 Consumer Safety Officers into the PI for Fiscal Year 2004. In addition, a specialized training curriculum will be developed for the PI to ensure that they are current on the latest technologies in pharmaceutical manufacturing processes. We also anticipate that the PI will continue to be trained in the future on new manufacturing technologies.