FDA draft guidance on ICH pharmacopoeial texts

The US Food and Drug Administration has announced the availability of a draft guidance entitled Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 4A: Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests General Chapter and was published in the Federal Register of August 5.

The draft guidance was prepared under the auspices of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The document provides the results of the ICH Q4B evaluation of the Chapter harmonized text from each of the three pharmacopoeias (US, European and Japanese) represented by the Pharmacopoeial Discussion Group. The draft guidance conveys recognition of the three pharmacopoeial methods by the respective ICH regulatory regions and provides specific information regarding the recognition. The draft is intended to recognize the interchangeability between local regional pharmacopoeias, thus avoiding redundant testing in favor of a common strategy in each region. It is part A of the fourth annex to the core Q4B guidance, which was made available in on February 21.