FDA Dose Content Uniformity Standards Could Be Replaced By IPAC Proposal
Executive Summary
FDA dose content uniformity standards could be replaced by IPAC-RS standards, the agency said during the Pharmaceutical Science Advisory Committee meeting March 13
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FDA dose content uniformity standards could be replaced by IPAC-RS standards, the agency said during the Pharmaceutical Science Advisory Committee meeting March 13. The standards recommended by the International Pharmaceutical Aerosol Consortium on Regulation & Science do not use a zero tolerance exclusion or establish a set sample size, two qualities that narrow FDA batch acceptance. "Should such a test be implemented, it would represent a win/win situation for both the consumer and the industry," FDA Office of Pharmaceutical Science Pharmacologist Wallace Adams, PhD, said. Issues surrounding IPAC-RS standards that need to be resolved before possible implementation by FDA include robustness of the test, impact of the zero tolerance criteria, and appropriate consumer risk. IPAC-RS standards will require an 85% batch coverage that falls between 75% and 125% of the product's labeled claim, with no zero tolerance requirement to exclude batches with product outside of a specified range of labeled claim. IPAC-RS standards also do not specify a required sample size. While some committee members believed a zero tolerance requirement to be necessary, many supported its elimination. "Somebody who wants to argue for zero tolerance criteria really has the burden of proof on them at this point," committee consultant Walter Hauck, PhD, Thomas Jefferson University, said. Committee members expect the proposed standards to increase FDA batch acceptance. In comments on draft guidance, members of industry stated FDA's acceptance criteria were too stringent (1 (Also see "MDI Guidance Dose Content Uniformity Specs Are Too Restrictive, Firms Say" - Pink Sheet, 8 Mar, 1999.), p. 29). Current FDA guidance, published in July 2002, uses a two-tiered test that stipulates not more than one of ten containers fall outside 80%-120% of its labeled claim, with zero tolerance for containers outside 75%-125%. The second tier tests samples from the beginning, middle, and end at around 200 doses of the product with the same requirements as the first tier. |