Summary of FDA's Proposed Changes to Cleaning Requirements for Biological Products

Microtest Laboratories has issued a management brief that discusses the FDA's proposed changes to cleaning requirements for biological products.

The FDA's proposed amendments to 21 CFR Parts 600, 610 and 680, published in the Federal Register on June 21, 2011, for review and comment, are focused on expanding the scope of the current sections to allow for greater flexibility in testing methodology. 21 CFR 610 currently requires the use of a culture-based method in evaluating sterility for biological products. The proposed changes would widen the scope to consider new non-culture based technology for sterility tests.


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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