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FDA FIELD STAFF WILL CONDUCT FOREIGN PRE-APPROVAL INSPECTIONS

Executive Summary

FDA FIELD STAFF WILL CONDUCT FOREIGN PRE-APPROVAL INSPECTIONS under a new program that starts Oct. 1, FDA International Programs Staff Deputy Director Peter Smith told the Pharm Tech '92 conference in East Brunswick, N.J. on Sept. 22. Smith said the agency plans to use "somewhere between 150 and 250 [U.S.] field investigators" to help meet the agency's growing foreign inspection workload. The purpose of the new foreign inspection program, Smith explained, is to reduce the International Programs Staff's backlog of assignments, which has remained around 200 for the past two years, while addressing requests from the agency's Centers to increase FDA's foreign inspection presence beginning in fiscal 1993. FDA's primary goal is to ensure "consistency and uniformity" between its U.S. and international inspection programs, FDA Mid- Atlantic Region Director Richard Davis stated. Smith noted that the Center for Drug Evaluation & Research has asked for 350 foreign inspections in FY 1993, up from approximately 200 in FY 1992, and that the Center for Devices & Radiological Health has asked for an even more dramatic increase in foreign inspections -- from 175 to 500. In addition, the Center for Food Safety & Applied Nutrition has requested the International Programs Staff to begin conducting food inspections and has targeted 200 for fiscal 1993. To meet its growing obligations, the International Programs staff will borrow field staff to conduct off-shore inspections. Smith said his office has asked FDA regional offices to provide the names of investigators willing to travel and "trained to do the type of work we do overseas." He noted that his office has a list of "around 170" names and began a training program with over 70 volunteers during the week of Sept. 14-18. Smith emphasized that pulling field investigators away from their district duties to help with foreign inspections will not affect FDA's pre-approval inspection response time in the U.S. Instead, field inspectors will spend less time on surveillance and sampling programs, Smith said. Details of the drug pre-approval inspection program will be explained in a foreign inspection guide that is currently being drafted within the agency, Smith said. "FDA has recognized for a while that there was a need for consistency of inspections and a uniformity of enforcement," he noted. "The agency is committed to a level playing field between foreign and domestic sites and, of course, we are going to be doing a significant increase in foreign inspections. We needed something to give our travelers information on how to operate overseas and on how this program is going to work." Because of the rapid growth in its workload, Smith's office has estimated that it will need at least $2.5 mil. "next year to pull off the foreign inspections we have been asked to do." He added: "That's a significant increase from FY 1992, when FDA will spend "about $750,000 on foreign inspections," and represents a "10-fold increase in just six years." In order to hold down the cost of sending teams of FDA inspectors overseas, the agency will ask manufacturers that are about to receive a pre-approval inspection to prepare and send a package of information to the assigned investigators three weeks prior to the inspection. Allowing the inspectors to review the company's manufacturing records prior to the inspection "will shorten the necessary time on site and thereby reduce the cost and allow us to do more inspections," Smith explained. In addition, the field offices are expected to help with administrative duties and inspection report reviews. "Getting the packages ahead of time will help them key on the areas we want to look at -- process failures, product failures, laboratory testing and process changes," Smith noted. Outlining the foreign inspection guide, FDA's Davis noted that for bulk drug inspections, which constitute the majority of overseas inspections, FDA would like to see: drug master files; validation and development reports; annual reports and production history; records on finished batches; failure and investigations reports for batches requiring rework and/or reprocessing; quality control/quality assurance standard operating procedures; cleaning validation reports; and microbiological data for products that will be used in sterile processes.
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