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PARAMETRIC RELEASE CAN REPLACE END-PRODUCT STERILITY TESTING

Executive Summary

PARAMETRIC RELEASE CAN REPLACE END-PRODUCT STERILITY TESTING for terminally heat-sterilized drug products, with an approved supplement for the procedure, according to the explanation of FDA's policy in a compliance policy guide recently released by FDA. Parametric release is defined by FDA as "a sterility release procedure based upon effective control, monitoring, and documentation of a validated sterilization process cycle in lieu of release based upon end-product sterility testing." Before a lot is released, the compliance guide states, "all parameters within the procedure must be met." The requirements for parametric release in lieu of end product sterility testing are described in the compliance guide. The parameters include validation of the sterilization process cycle and of the integrity of the container closure system employed, bioburden testing, and the inclusion of chemical or biological indicators in each truck, tray, or pallet of each sterilizer load. Discussing validation of the sterilization process cycle under parametric release, FDA notes that "failure of more than one critical parameter must result in automatic rejection of the sterilizer load." Where equipment malfunction prevents measurement of one critical cycle parameter, the guide states that biological indicators (BIs) can be used to evaluate cycle lethality. However, FDA notes, "if more than one critical parameter is not met, the batch is considered non-sterile despite BI sterility." The compliance policy guide requires NDA holders to have approved supplements providing for parametric release. The allowance for parametric release was first made by the agency in 1985, the guide notes, when supplemental NDAs covering the procedure were approved for a few large volume parenteral drug products. The guide is available from FDA's Dockets Management Branch, Rm. 4-62, 5600 Fishers Lane, Rockville, MD 20857.

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