Fed Regist. 2009 Apr 8;74(66):15989-90.
The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 4B: Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms General Chapter." The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance provides the results of the ICH Q4B evaluation of the Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms General Chapter harmonized text from each of the three pharmacopoeias (United States, European, and Japanese) represented by the Pharmacopoeial Discussion Group (PDG). The guidance conveys recognition of the three pharmacopoeial methods by the three ICH regulatory regions and provides specific information regarding the recognition. The guidance is intended to recognize the interchangeability between the local regional pharmacopoeias, thus avoiding redundant testing in favor of a common testing strategy in each regulatory region. In the Federal Register of February 21, 2008 (73 FR 9575), FDA made available a guidance on the Q4B process entitled "Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions."
美国食品药品监督管理局（FDA）宣布发布一份指南，题为“Q4B《用于人用药品注册的技术要求国际协调会议（ICH）地区药典文本的评估与推荐；附件4B：非无菌产品的微生物检查：特定微生物的检测 通则》”。该指南是在人用药品注册技术要求国际协调会议（ICH）的主持下制定的。该指南提供了ICH Q4B对非无菌产品微生物检查：特定微生物检测通则协调文本的评估结果，该协调文本来自药典讨论组（PDG）所代表的三部药典（美国、欧洲和日本）。该指南传达了三个ICH监管地区对这三种药典方法的认可，并提供了有关认可的具体信息。该指南旨在认可各地区药典之间的互换性，从而避免重复检测，支持各监管地区采用共同的检测策略。在2008年2月21日的《联邦公报》（73 FR 9575）中，FDA发布了一份关于Q4B流程的指南，题为“用于ICH地区的药典文本的Q4B评估与推荐”。
