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Executive Summary

ASEPTIC PROCESSING OR TERMINAL STERILIZATION: REGULATION CHANGES to clarify FDA policy in favor of terminal sterilization, when practical, are under consideration, FDA Division of Manufacturing and Product Quality Director Edmund Fry told a meeting of the International Society of Pharmaceutical Engineers (ISPE) in Bethesda, Md. March 14. Fry said that FDA is "preparing a published policy" on the issue, which he predicted "will take the form of changes to the FDA regulations." The policy statement will indicate that terminal sterilization must be employed unless specific criteria justifying aseptic processing are met, Fry said. The current agency perspective, Fry explained, is that there are two justifications for concluding that terminal sterilization is not feasible: where the drug substance cannot withstand heating, and therefore would not be available to patients without aseptic processing; and where the container closure system offers a clear benefit to patients but cannot withstand terminal sterilization. As an example of the latter, Fry cited a prefilled syringe: potential contamination occuring during preparation of the drug for administration would be avoided. The amount of data needed to justify aseptic processing on the basis of patient benefit would not necessarily be burdensome, Fry said. In turn, he explained, the ability of a drug substance to withstand heat "is either established in the literature or is easily determined during the course of stability studies which would be undertaken in any event." FDA will not withhold approval of new drug applications for failure to justify aseptic processing until a formal FDA policy is published and the time period for implementation has elapsed, Fry told the industry group. He noted, however, that justifications will be encouraged by FDA "to help determine which products in the future are amenable to terminal sterilization and to educate ourselves as to the form justification should take." FDA's bias toward terminal sterilization is supported by the number of recalls, several involving serious health consequences, associated with aseptic processing. Fry noted that during the past seven years "there have been recalls of at least 45 different parenteral products because they were contaminated or because they lacked assurance of sterility arising from the poor conditions under which they were manufacturered. Of these 45, virtually all were aseptically processed." Among these were products which could have been terminally sterilized or formulated with preservatives to mitigate the risk, Fry noted. Fry emphasized that the FDA policy under consideration "will still leave many products aseptically processed." In order to minimize the risk of any contamination in those products, the FDA official suggested that, where feasible, firms should apply some degree of heat after the products are sealed in their final containers. The "judicious use of preservatives" is another alternative, he noted. Fry said that a mandatory rule favoring terminal sterilization may be "quite a ways off," and that once it is issued, "ample time" would be allowed firms to adapt to the new policy. However, he asserted, "there is no reason why the pharmaceutical industry should not begin planning now to move toward employing terminal sterilization where feasible."

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