Zdrowie i gospodarka · 22/12/2009

FDA Releases Guidance on Harmonized Sterility Test for Pharmaceuticals

The Food and Drug Administration (FDA) has made available a guidance document that outlines the results of the International Conference on Harmonisation's (ICH) Q4B evaluation of the Sterility Test General Chapter, a harmonized text for pharmaceutical testing, and recognizes the interchangeability of testing methods across three pharmacopoeias, aiming to reduce redundant testing and promote a common testing strategy.