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原文如下:
1. Are USP general chapters above <999> considered equivalent to FDA guidance? What are their purpose and how should manufacturers use these informational chapters?
1. USPUSPUSP通用章节 通用章节 通用章节 (凡例) (凡例) 是否与 是否与 FDA FDA指南 同等效力 ?它们的 目它们的 目和生产企业 生产企业 该如何 应用 这些章节? 这些章节?
No, FDA is the only source of policy on pharmaceutical CGMPs and quality. CGMP requirements are found in statutes and regulations, and FDA’s current thinking on these requirements is explained in the Agency’s guidance documents.
不等同,FDA是药品cGMPs和质量政策方针唯一的来源。cGMP的要求体现在法令和条例中,而且FDA对这些要求的现行考量在当局的指导性文件中做出了解释。
The USP is a private, non-governmental organization. While products labeled as USP are required to meet the criteria in product monographs when tested by the methods of analysis outlined in the tests and assays section, the suggestions found in General Chapters above <999> are only informational. The views expressed in these chapters are solely USP’s. As with all information sources, these chapters might include some recommendations that may help a firm meet CGMPs.
USP(此处应解释为美国药典委员会,下同)是私立的、非政府机构。当产品标识上有USP,在使用“检测与分析章节”中的分析方法时则需要满足产品文献中的标准,上述<XXX>通用章节(凡例)的建议仅作为信息。这几章(凡例)中仅是USP的观点。和所有信息来源一样,这些章节可能包含一些帮助企业符合CGMPs的建议。
可以这么理解,假如USP与FDA的指南不一致,那么遵照指南?USP是私立的?不是法规么? |
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