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CEPHALOSPORINS MAY REQUIRE SEPARATE MANUFACTURING FACILITIES

Executive Summary

CEPHALOSPORINS MAY REQUIRE SEPARATE MANUFACTURING FACILITIES to avoid a cross-contamination problem, FDA investigator Henry Avallone told a June 5 meeting of the International Association of Pharmaceutical Engineers (ISPE). While existing regulations do not specify complete separation of cephalosporin facilities, Avallone noted, FDA investigators will want assurances that cross-contamination will not occur. Providing that assurance without isolating the manufacturing process, he stated, may not be possible. The extra controls on air systems required for penicillin production, the FDA investigator said, should also be applied by cephalosporin manufacturers. Like penicillin, he noted, "one could make a case for zero tolerance for cephalosporin" in other products. In addition, "both products are very light, spread easily throughout a facility and are very difficult to remove once present." With the sensitive analytical methodology available, Avalone maintained, "it would seem to be difficult for a manufacturer of either a penicillin or a cephalosporin with other products to validate an air system with a zero tolerance level." Avallone said that if he "came across something like this on an inspection," he would ask the company to "prove to me you don't have cephalosporin contamination in your environment where you are making the noncephalosporin product." Validating the air system under these conditions, he noted, would be "very difficult." The FDAer indicated that the agency is finding more sterility-related GMP problems as originator patents expire and the number of cephalosporin manufacturers increases. One example of GMP problems with cephalosporins occurred in July 1986, when SmithKline recalled 54,000 vials of its Ancef cephaloposporin after an FDA inspection turned up several GMP deviations ("The Pink Sheet" Sept. 8, T&G-7). The manufacture of sterile powders for injection, in general, Avallone said, may be "the most challenging operation in the drug industry," and there are a "number of issues which are bound to present problems." The FDA investigator stressed the importance of communication between dosage form manufacturers and bulk powder suppliers in preventing problems with the final product. Although purity specifications for the sterile powders may not be spelled out in the compendia or Code of Federal Regulations, Avallone said, the agency will expect "that bulk drug manufacturers have specifications for levels of impurities." In addition, "it is recommended that the sterile dosage form manufacturer be aware of these impurities and establish in-house specifications." FDA investigators will also expect manufacturers to have established limits for solvent residues, he noted. Avallone said that recalls of sterile powder dosage forms have followed from a particulate problem in the bulk powder and lack of sample testing. In general, he emphasized, in order to ensure the quality of the final powder, "it is extremely important to know the process and control at the sterile bulk supplier."

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