FDA Manufacturing Inspections To Focus On Sterile, New Facilities In FY 2003
This article was originally published in The Tan Sheet
Executive Summary
FDA will continue to emphasize inspection of sterile manufacturing facilities in fiscal year 2003, Division of Manufacturing & Product Quality Director Joseph Famulare said Dec. 11
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FDA will continue to emphasize inspection of sterile manufacturing facilities in fiscal year 2003, Division of Manufacturing & Product Quality Director Joseph Famulare said Dec. 11. "We want to make sure that we inspect at least 50% of our inventory to give a biannual inspection coverage to all sterile manufacturers," Famulare told analysts during a Merrill Lynch Global Healthcare conference call. He noted such products could be sold by prescription or OTC. "Any lack of sterility assurance is an important issue so...we want to make sure that those firms get increased coverage in our risk-based approach," he continued, adding that "lack of sterility of assurance has been one of the major reasons for recalls in this past fiscal year." FDA also plans to inspect the anticipated 100 new pharmaceutical firms that will register with the agency in FY 2003, Famulare said. "New establishments pose a high risk because we've never inspected them before, nor do we necessarily know all of the products that are being manufactured there," he explained. FDA's risk management approach to drug good manufacturing practices could lead the agency to apply different levels of scrutiny to OTC and Rx drugs (1 (Also see "OTC, Rx Drug Risk Equation May Be Altered In Upcoming GMP Plan" - Pink Sheet, 21 Oct, 2002.), p. 3). FDA publicly announced plans to update pharmaceutical cGMPs in August. "We're hoping that our involvement in this way using this initial risk management approach will allow us to go to the firms that are the most important to the agency - most important in terms of risk to the patient - and to help mitigate problems beforehand by our increased inspectional scrutiny," Famulare said. FDA also aims to inspect all prescription drug manufacturers on a biannual basis. Therefore, Famulare pointed out, "in this fiscal year we'd want to [inspect] approximately 50% of the Rx drug manufacturers," which adds up to 1,276 projected inspections by October 2003. The goal "still allows for coverage of the other lower risk categories," he noted, "but not at the frequency that some of these higher risk categories warrant." |