FDA Eases Sterility Requirements

The US Food and Drug Administration has relaxed some of the rules governing how companies must test the sterility of materials used to make biologic drugs.

Bob Grant
Bob Grant

Bob Grant is Editor in Chief of The Scientist, where he started in 2007 as a Staff Writer.

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May 16, 2012

WIKIMEDIA COMMONS, LASTORSET

Drug companies that manufacture biologics—drugs, vaccines, or diagnostics made using living organisms—will have less trouble testing and proving the sterility of their materials and products when new rules outlined by the US Food and Drug Administration go into effect next month.

The FDA’s detailed rules, which appeared in the Federal Register at the beginning of May, hinge upon state-of-the-art testing methods, which should make determining the sterility of biological products and the materials used to make them simpler. Specifically, the rules eliminate specified sterility test methods, culture media formulae, and culture media test requirements; eliminate the specified membrane filtration procedures required for certain products; eliminate specified sterility test requirements for most bulk material; modify the repeat sterility test requirements, so that repeat tests will occur only once for each product lot; and replace storage and maintenance requirements, testing sample sizes, and test interpretations with simplified guidelines.

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The rules go into effect on June 4.

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