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本帖最后由 孙艳红 于 2025-3-6 21:45 编辑
如题。
继ECA的AIQSV之后，大漂亮也开始往集成方向发力了；难道都是降本增效惹的祸？
非也，AIQ或CSV各行其是本来就存在割裂感和不团结的意味……
所以更新吧，挺好。
而且，2025版的中国药典，指导原则 9094 分析仪器确证 ，也已经在我的建议下，把AIQSV的观点吸收了。
总结来说，USP和CHP的指导原则来得比较提纲挈领，但可操作性差一些；ECA的指南更具可操作性和启发性。
虽然欧盟除了OMCL给出了仪器确认的规则外，计算机相关的确不是很充分（仅秋夕而言），但人家有ECA呀。
-----------------------------------------------------华丽的分割线---------------------------------------------------------------
打字确认是不好玩，如果你先想看看更具操作性的整合，可以去截图自己提前学习。
否则，你慢慢你用EDGE和沉浸也能先去USP自己看。
当然，之①刚刚开始……
BRIEFING 简报 〈1058〉 Analytical Instrument Qualification. This chapter is based on the version of the chapter official as of August 1, 2017. General chapter 〈1058〉 was originally published in 2008 and last revised in 2017. Since 2008, there have been important improvements that must be addressed, including [color=blue !important]Analytical Procedure Life Cycle 〈1220〉 and increased awareness of the need for continuous monitoring and control to ensure compliance.
〈1058〉 分析仪器确认。本章基于截至 2017 年 8 月 1 日的章节官方版本。指导原则 〈1058〉 最初出版于 2008 年，最后一次修订于 2017 年。自 2008 年以来，包括[color=blue !important]分析程序生命周期 〈1220〉的增加，以及意识到需要持续监测和控制以确保合规性，有一些重要的改进必须解决 。
 General chapter 〈1058〉 is unique in the regulatory sector. It is widely regarded and used globally by regulators, suppliers, and industry. It provides a framework for establishing “fitness for intended use” of apparatus, analytical instruments, and systems.
指导原则〈1058〉 在监管领域是独一无二的。它在全球范围内得到监管机构、供应商和行业的广泛重视和使用 。它为“适合预期用途“的器具、分析仪器和系统提供了一个框架。
 Given the structure of current chapter 〈1058〉, the Chemical Analysis Expert Committee considered it appropriate to restructure rather than just amend it. Life cycle approaches are recommended and the 4Qs model will be maintained although it has some weaknesses. These are addressed to avoid confusion and highlight nomenclature misunderstandings. Some of the existing content is reused or repositioned.
鉴于当前章节 〈1058〉的结构，化学分析专家 委员会认为对它重组比仅仅打补丁更合适。重组基于生命周期的方法论，并且 4Qs 模型将保持不变，尽管它有一些不足。解决这些问题是为了避免混淆并消除误解。一些现有内容被重用或重新定位。
 In addition, there are two new general chapters in preparation for a future issue of PF: Process Analytical Technology—Theory and Practice 〈1037〉 and Ongoing Procedure Performance Verification 〈1221〉. [color=blue !important]Chemometrics 〈1039〉 and [color=blue !important]Good Documentation Guidelines 〈1029〉 on good documentation practice and data integrity are in revision.
此外，还有两个新的指导原则，为未来一期的 PF 做准备：过程分析技术 - 理论与实践 〈1037〉 和持续程序性能验证 〈1221〉。此外，关于良好文档实践和数据完整性的[color=blue !important]良好文档指南 〈1029〉和 [color=blue !important] 化学计量学 〈1039〉 也在 校订。
 Another reason for rewriting this chapter is the intent for above 〈1000〉 general chapters to provide general guidance for stakeholders. It is important to put “what needs to be done” in the context of “why it needs to be done”. The decision of “how it needs to be done” is the prerogative of individual organizations.
重写本章的另一个原因是1000号以上的指导原则的立意是 ，提供利益相关者的一般指南。将 “该干啥” 放在 “为啥该干它” 的上下文。而“需要如何完成”的决定是具体组织的责任。
 This proposed revision is based on three Stimuli to the Revision Process articles (SRPs):
此拟议修订基于三篇修订研究中的激励文章 ：
 (GCM: E. Biba) （GCM：E. Biba）
 Case ID—SUB-1755
案例 ID — SUB-1755
 Current DocID: GUID-EA8F36CE-5B60-4CA4-A3B8-51F22DE87BC6_1_en-US
当前文档 ID： GUID-EA8F36CE-5B60-4CA4-A3B8-51F22DE87BC6_1_en-US
The following Briefing list includes monographs and/or chapters that both reference the General Chapter under revision and require revision to keep references to the General Chapter accurate. Other monographs and/or chapters may also be listed, even where the reference to the General Chapter remains unchanged, as additional notice to stakeholders where there is believed to be potential for the change in the general chapter itself to affect pass-fail determinations for particular monograph articles.
以下简报清单包括了那些既引用了正在修订的通则又需要进行修订以确保对通则的引用准确无误的各论和/或通则。即使指导原则的提法保持不变，其他各论和/或通则也可能被列出，作为对利益相关者的额外通知，指导原则本身的变化可能会影响特定各论的“通过-不通过”决定。
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发表于 2025-3-6 20:47:38
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