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Executive Summary

IMS WILL DISCONTINUE EITHER CEPHALOSPORIN OR PENICILLIN PRODUCTION at its Tempe, Ariz. plant in response to an FDA regulatory letter issued July 27. Among good manufacturing practice (GMP) deviations cited in the reg letter was the failure by IMS "to adequately separate the facilities used for the manufacture, processing, and packing of penicillin products from those used for other drug products for human use." In its response to the reg letter, IMS informed FDA that it would discontinue manufacturing either the cephalosporin or penicillin product currently being produced at the Tempe plant, although a decision as to which product would be discontinued has not yet been made. The two antibiotic lines are the only products currently manufactured by IMS at that facility. In communications to FDA, IMS had maintained that the cephalosporin and penicillin products could be safely produced in the Tempe facility with adequate controls. The Tempe plant included separate air handling systems for the two antibiotic lines. FDA responded in the reg letter that current regulations require "separation of facilities." In addition, FDA noted that IMS' existing controls were not adequate: (1) cleaning procedures for removing residual penicillin in the cephalosporin manufacturing area had not been validated; (2) exhaust air from the penicillin area was not deactivated; and (3) air in the cephalosporin area was not being monitored for the presence of penicillin. The reg letter also cited inspection findings that the aseptic powder filling process at the Tempe plant had not been adequately validated, and that quantitative air sampling procedures at the plant did not meet CGMP standards. According to the letter, IMS offered FDA the results of environmental monitoring and end product sterility testing in lieu of media fills as validation evidence. The agency affirmed in the letter that, while not required, media fills are generally accepted validation practice, and that the environmental and sterility test data presented by IMS were not an adequate substitute. In its response, IMS informed FDA that media fill validation of the filling process is underway. IMS also has had problems with FDA recently involving the denial of three IMS applications that FDA asserted did not provide adequate sterility control information. IMS maintained to FDA in response that the agency's grounds for denying the applications were not sufficient, and requested a formal hearing to review the issue ("The Pink Sheet" June 27, T&G-8).

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