AGAWAM, MASS. – April 4, 2012 – The new scope of biologics sterility testing, resulting from the U.S. Food and Drug Administration’s (FDA) proposed changes to 21 CFR 610, is discussed in a new management brief from Microtest Laboratories. Download the brief from http://www.microtestlabs.com/21-cfr-610-paper.
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.
“Through these changes, the FDA is embracing the emergence of new non-culture based technologies. If approved, they will provide the opportunity to utilize these methods as alternatives to culture-based sterility tests,” explains James E.T. Gebo, B.S., M.P.A., RM (NRCM), Technical Representative, Laboratory Services, Microtest Laboratories, in the brief, “Proposed Changes to 21CFR 610: The New Scope of Biologics Sterility Testing.”
“The most significant proposed revision is the elimination of the specified sterility test methods,” writes Gebo. “But 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.
Download the new free management brief, “Proposed Changes to 21CFR 610: The New Scope of Biologics Sterility Testing,” at http://www.microtestlabs.com/21-cfr-610-paper.
Microtest is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries. Based in Agawam, Massachusetts, U.S.A., the company’s expertise and flexible processes enhance product safety and security, accelerate time to market, and minimize supply chain disruption. For more information, visit http://www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680. Follow Microtest Labs on Twitter @MicrotestLabs at http://twitter.com/MicrotestLabs.