Sterility Testing of Biological Products - How to Comply with New FDA Draft Guidance
Abstract:On May 3, 2012, the FDA released new guidance on ‘Sterility Testing of Biological Products’ after revising the existing requirements for licensed biological products. The new rule on sterility eliminated specific requirements for most products and aims to establish a system in which manufacturers can adopt product-specific and appropriate testing procedures.
This article discusses the potential implications and requirements of the regulation.
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