翻译：Julia 来源：Julia法规翻译
Questions and Answers on Current Good ManufacturingPractices—General Provisions
CGMP问答---通则
1. Are USP general chaptersabove <999> considered equivalent to FDA guidance? What is theirpurpose and how should manufacturers use these informational chapters?
USP中大于<999>编号的通则是否等同于FDA指南？其目的是什么？生产商要如何使用这些参考类章节？
No, FDA is the only source of policy on pharmaceutical CGMPs andquality. CGMP requirements are found in statutes and regulations, andFDA’s current thinking on these requirements is explained in the Agency’sguidance documents.
不等同，FDA是药品CGMP和质量政策的唯一来源。CGMP要求可以在法律法规中找到，FDA对这些要求当前的观点在当局的指南文件中进行解释。
The U.S. Pharmacopeial Convention is a private, nongovernmentalorganization that publishes the United States Pharmacopeia (USP) and theNational Formulary (NF) as official compendia of the United States. Althoughmuch of the USP and NF is legally enforceable, the USP general chaptersnumbered above <999> (general information chapters) are informational andgenerally do not contain any mandatory requirements (see USP General Notices2.10). General information chapters might include some recommendations that mayhelp a firm meet CGMPs.
美国药典委员会是私有的非政府组织，它发布美国药典（USP）和国家处方（NF），是美国的正式药典。尽管USP和NF中许多部分是强制执行的，但USP通则号大于<999>的内容（一般信息章节）仅供参考，通常并不包括任何强制要求（参见USP凡例2.10）。通则章节可能会包括有一些帮助公司符合CGMP的建议。
Date: 6/14/2007
2. How does one comment onFDA’s proposed guidance documents? How about USP proposals?
我们如何给FDA所拟的指南文件提建议？USP呢？
Both USP and FDA have mechanisms in place for interested parties to makecomments on proposed documents.
USP和FDA均设有机制让利益相关方对所拟文件提出建议。
Guidance Documents 指南文件
FDA’s proposed guidance documents are written using good guidancepractices and published for comment per 21 CFR 10.115. They are easilyaccessible to the public via our Web site and through the Federal Register. FDA’s Division ofDockets Management is the office responsible for receiving all comments onproposed guidance. Interested parties can read and submit comments viaFDA’s Dockets Management Web site. FDA reviews allreceived public comments, makes appropriate modifications, and publishes afinal document.
FDA所拟的指南文件制订和发布均依据21CFR10.115优良指南规范。公众可以很容易地通过我们的网页和《联邦公报》获取。FDA的文件管理中心是负责接收所有拟定指南建议的办公室。利益相关方可以通过FDA的文档管理网页调阅和呈交建议。FDA将审核所有收到的公众建议，进行适当修订，再发布最终文件。
USP Monographs USP各论
USP publishes proposed chapters or monographs in the PharmacopeialForum, a publication that is issued bimonthly. USP subscribershave access to these publications and can send comments (within a 90-day postpublication comment period) for consideration by the USP. Finalizedproposals (official revisions, new chapters, or monographs) are published insubsequent supplements to or editions of the Pharmacopeia.
USP每2个月在“药典论坛”发布其所拟章节或各论。USP订阅者可以查看这些公布信息，可以发送建议供USP考量（自发布日开始的90天征求意见期内）。最终确定的拟文（正式修订、新章节或各论）将在随后的增补中或编辑中发布。
Date: 4/30/2009
