Zdrowie i gospodarka · 05/08/2008

FDA Releases Draft Guidance on Microbiological Examination of Non-Sterile Products for Pharmaceutical Use

The US Food and Drug Administration (FDA) has made available a draft guidance document outlining the evaluation and recommendation of pharmacopoeial texts for use in the International Conference on Harmonisation regions, specifically focusing on microbiological examination of non-sterile products. The document aims to recognize the interchangeability of methods among the three ICH regulatory regions and the three pharmacopoeias (US, European, and Japanese) represented by the Pharmacopoeial Discussion Group.