Guidance tells how to skip the sterility test

Drugmakers using a sterility assurance release program can take a pass on sterility testing of finished units, according to FDA guidance. In a parametric release program, a drugmaker's demonstrated control of the sterilization process allows it to use defined critical process controls to meet 21 CFR regulations. "Meeting the requirements of the parametric release process can provide greater assurance that a batch meets the sterility requirement than can be achieved with a sterility test," according to the guidance. Report (.pdf)

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