Proposed Changes to 21 CFR 610:

The New Scope of Biologics Sterility Testing

By James E.T. Gebo

On June 21, 2011, the U.S. Food and Drug Administration (FDA) had its proposed amendments to 21 CFR Parts 600, 610, and 680 published in the Federal Register for review and comment. The FDA's proposed changes are focused on expanding the scope of the current sections to allow for greater flexibility in testing methodology. Currently, 21 CFR 610 specifies the use of a culture-based method in the evaluation of sterility for biological products. Through these changes, the FDA is embracing the emergence of new non-culture based technologies and providing the opportunity to utilize these methods as alternatives to culture-based sterility tests.

In this brief, Gebo discusses the new scope of biologics sterility testing resulting from the proposed changes – the most significant of which is the proposed revision is the elimination of the specified sterility test methods. He notes that while the proposed changes seem extreme at first glance, in the grand scheme they are beneficial for all interested parties.

The brief discusses the potential benefits, including the opportunity for manufacturers and quality control laboratories to streamline their testing and adopt new emerging sterility test technologies — such as rapid testing methods employing PCR — that will further support the drive to achieve quicker product release.

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