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Executive Summary

FDA WILL ISSUE BATCH SIZE POLICY CLARIFICATION following meetings with the Generic Pharmaceutical Manufacturers Association and the National Association of Pharmaceutical Manufacturers. A clarification of the interim policy could come as early as the week of Sept. 3, FDA said. FDA Office of Generic Drugs officials met with GPIA Aug. 22 and NAPM Aug. 28 to discuss a guidance issued in July specifying batch sizes for ANDA bio-equivalence testing ("The Pink Sheet" July 23, p. 9). Mylan also has met with the agency on the issue. The associations have taken issue with several points of the policy statement but particularly object to the requirement that biotesting batches be produced on the same equipment as used for scaled-up production. Noting that for oral dosage ANDAs the guidance requires that 100,000 units or 10% of the proposed production batch be used in a biotest, the groups maintain that a batch of this size cannot be made on equipment intended to manufacture one mil. tablets. GPIA maintains that production of generic products is at a standstill pending resolution of this issue. In the July guidance, FDA noted that there is "limited supporting technical data on which to base a policy allowing for less-than-full, commercial-scale test batches." However, the agency reports that "the policy as currently stated does have broad support in the Division of Generic Drugs and is based primarily on a judgment that it appears to be -- for industry and for the consumer -- both practical and reasonable." GPIA and NAPM have suggested that FDA permit smaller scale-up equipment as long as it is validated. In addition, they have asked for a clarification of the definition of the 100,000-unit test batch size, specifically whether it allows for the normal 5% to 10% loss of material or whether instead companies should produce a batch size of 120,000 units to make up for losses normally occuring during production. NAPM also has recommended that FDA allow R&D personnel to be involved in the manufacturing process. GPIA maintains that FDA should not implement any changes in the original batch size policy established in January 1988 until the agency holds a workshop to collect technical data. In an Aug. 23 letter to Office of Generic Drugs Acting Director Bruce Burlington, GPIA said that it hopes that "with respect to allowable changes in equipment size, there will be no interim reversal of the policy, which was announced by the Division of Bioequivalence in January 1988, until technical data to be presented at this workshop is fully evaluated." FDA is said to be planning such a workshop for February 1990. Although the batch policy guidance addresses only oral dosage non-antibiotic ANDAs, GPIA suggested in its letter that "all immediate release dosage forms, including antibiotics, be addressed at FDA's upcoming workshop on preapproval and postapproval batch sizes and scale-ups."



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