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Pharmaceutical cGMPs for the 21st
Century: A Risk-Based Approach
Progress Report of
the Pharmaceutical Inspectorate
Working Group
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.
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Date created: February 27, 2003 |
