亚太地区无菌和支原体检测中替代和快速微生物方法的质量控制要求指南。

Q3 Medicine
Juliana Gutierrez
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引用次数: 0

摘要

虽然替代和快速微生物学方法(ARMM)在欧洲和美国获得了更广泛的接受,欧洲药典和美国药典已经提供了关于其验证和实施的指导,并且它们的使用得到了监管机构和行业团体的支持,但在亚太等其他地区,它们的采用更为有限。本文旨在回顾亚太地区ARMM的监管格局,特别关注无菌和支原体检测。它将审查包括中国、台湾、日本、韩国、印度、印度尼西亚、泰国和越南在内的主要医药市场的相关药典章节和地方指南。该分析将局限于有自己药典的市场,在评估这些市场采用这些新技术的准备程度的同时,为浏览现有和未来法规的格局提供全面指导。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
A Guide to Navigating Quality Control Requirements for Alternative and Rapid Microbial Methods in Sterility and Mycoplasma Testing Across the Asia Pacific Region.

While alternative and rapid microbiological methods (ARMM) have gained broader acceptance in Europe and the United States, where guidance on their validation and implementation has been made available by the European Pharmacopoeia and United States Pharmacopoeia and their use has been supported by both regulators and industry groups, their adoption in other regions such as Asia Pacific has been more limited. This article aims to review the regulatory landscape for ARMM in the Asia Pacific region, focusing specifically on sterility and mycoplasma testing. It will examine relevant pharmacopoeial chapters and local guidelines in key pharmaceutical markets, including China, Taiwan, Japan, South Korea, India, Indonesia, Thailand, and Vietnam. The analysis will be limited to markets with their own pharmacopoeia, providing a comprehensive guide to navigating the landscape of existing and future regulations while assessing the readiness of these markets to adopt these new technologies.

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CiteScore
1.90
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