What are the differences between the Pharmaceutical Inspectorate (PI) and evolving cadre of the Product Specialists?
The Pharmaceutical Inspectorate will be a group of Field Investigators who have specialized experience and specific training in evaluating pharmaceutical manufacturing. The “Specialists” are staff members in the Centers and Field who are experts on the science associated with complex products and technologies. “Specialists” may accompany Investigators during an inspection or will otherwise be available to provide scientific support during the course of an investigation. For more information on the “Specialist” program, refer to the “Potential Use of Specialists — An Emerging Team Approach” [http://www.fda.gov/cder/gmp/Specialist-Diagram.pdf] and the progress report on “Specialists on Inspection Teams” [http://www.fda.gov/cder/gmp/productspecialists.htm].
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