USP关于元素杂质<232>问答----Julia

巴西木

原文来自USP官网，版权归属原作者，译文仅供参考

Frequently Asked Questions Regarding the Implementation of USP General Chapters <232> Elemental Impurities ----Limits, <233> Elemental Impurities ----Procedures, and <2232> Elemetal Contaminants in Dietary Supplements

关于USP通论<232>“元素杂质—限度”、<233>元素杂质—检验方法和<2232>“膳食补充剂中的元素污染”常见问题回答

Version 3: December 27, 2013

版本号3：2013年12月27日

1.       How will General Chapters <232> Elemental Impurities----Limits and <2232> Elemental Contaminants in Dietary Supplements become applicable to monographs? Will they apply to all monographs or just to drug products?

General Chapters may be applied by reference in a monograph, by reference in an already applicable general charpter, or by a statement in General Notices that specifies their broad applicability. USP will apply General Chapters <232> and <2232> to monographs via General Notices provision 5.60.30 Elemental Impurities in USP Drug Products and Dietary Supplements. General Chapter <232> will apply to drug products currently in the USP-NF. General Chapter <2232> will apply to finished dietary supplement dosage forms. The General Chapters also could be made applicable by reference in any monograph on a case-by-case basis.

问：通论<232>和<2232>会怎么样应用于各论中？是会适用于所有各论还是只适用于制剂各论？

答：通论可以通过各论中的引用来应用，也可能通过在已采用的通论中引用来应用，还可以是通过通则申明来指定其适用范围。USP会通过通则5.60.30来将通论<232>和<2232>应用于USP药用物质和膳食补充剂。通论<232>会应用于目前录入USP-NF的所有制剂。通论<2232>会应用于膳食补充剂成品。上述2通论也会通过各案分析来在各论中引用。

2.       When will conformance to General Chapters <232> and <2232> be required?

General Notices 5.60.30 Elemental Impurities in USP Drug products and Dietary Supplements will become official on December 1, 2015, making General Chapters >232> and <2232> broadly applicable to drug products (<232>) and finished dietary supplement dosage forms (<2232>) in the USP-NF as of that date. Only in the event that a monograph specifically references one of these General Chapters could they be required prior to December 1, 2015, and then only for the article covered by that specific monograph.

问：要求什么时候符合通论<232>和<2232>?

答：通则5.60.30“USP制剂和膳食补充剂中的元素杂质”会在2015年生效，这样通论<232>和<2232>将会在该日期起广泛适用于收载入USP-NF的制剂（<232>）和成品膳食补充剂（<2232>）。

3.       Are General Chapters <232> Elemental Impurities – Limits, <233> Elemental Impurities –Methods, and <2232> Elemental Contaminants in Dietary Supplements currently official?

General Chapters <232> and <233> became official February 1, 2013; General Chapter <2232> became official August 1, 2013. Until General Notices 5.60.30 Elemental Impurities in USP Drug Products and Dietary Supplements becomes official on December 1, 2015, however, these General Chapter would be applicable only if they are referenced in a particular monograph.

It is important to note that revisions to General Chapters <232> and <233> are proposed in Pharmacopeial Forum 40(2) [March-April 2014] with changes related to the ICH Q3D Step 2 document as well as other editorial changes. General Chapters <232> and <233> will remain official in their current form until the revisions published in PF 40(2) become official, likely in Supplement 1 to USP 38-NF 33 (August 1, 2015).

问：通论<232>“元素杂质—限度”、<233>“元素杂质—检验方法”和<2232>“膳食补充剂中的元素污染物”现在是否生效？

答：通论<232>和<233>将于2013年2月1日生效；通论<2232>将于2013年8月1日生效。通则5.60.30“USP制剂和膳食补充剂中的元素杂质”将于2015年12月1日生效。但是这些通论将只应用于对其有引用的各论中。
要重点注意的是，在药典论坛40（2）【2014年3-4月】中提出了对通论<232>和<233>的修订，以反应ICH Q3D第二步文件相关的变更，以及做一些文字编辑性的修订。通论<232>和<233>现行版本将保持有效，直至PF40（2）的修订版生效。可能是会在USP38-NF33的第一次增补中（2015年8月1日）。

4.       Why doesn’t General Notices provision 5.60.30 Elemental Impurities in USP Drug Products and Dietary Supplements reference General Chapter <233> Elemental Impurities ---Procedures?

General Chapter <233> will be made applicable by being referenced in General Chapter <232> and <2232>, and thus does not need to be referenced separately in General Notices 5.60.30. General Chapter <233> already is applicable in certain cases through reference in currently official monographs (see question #1).

问：为什么通则5.60.30“USP制剂和膳食补充剂中的元素杂质”不引用通论<233>“元素杂质—检验方法”呢？

答：通论<233>会在通论<232>和<2232>中被引用，因此不必要单独在通则5.60.30中引用。通论<233>已经通过在现行生效的各论中通过引用开始使用（参见问#1）.

5.       Why is USP’s revision to General Chapter <232> not fully aligned with the limits specified in the ICH Expert Working Group Q3D Step 2b draft?

The limits in the proposed revision to General Chapter <232> reflect a review of published toxicological data and studies, as well as expert review by toxicologists serving on the Elemental Impurities Expert Panel. In some cases, USP’s proposed limits diverge from the Q3D Step 2b limits, and USP has notified ICH of these divergences via a comment letter on the Step 2 documents. USP welcomes public comment on the proposed revisions to <232> through May 31, 2013.

问：为什么USP对通论<232>的修订内容与ICH专家工作组Q3D第2b的草案不是完全一致的呢？

答：在所拟的通论<232>修订草案中的限度反映了对公开的毒性数据和毒性研究的审核，以及由元素杂质专家委员会毒理学家所进行的审核。在有些案例中，USP所拟定的限度与Q3D第2b中的限度不一致，USP已经通过建议函知会了ICH关于第二步文件上的这些不同点。USP欢迎公众对2013年5月31日所拟的<232>修订草案提供建议。

6.       Will General Chapter <231> be omitted once General Chapters <232> and <2232> become applicable?

USP General Chapter <231> will be omitted once General Chapter <232> and <2232> become applicable on December 1, 2015. The removal of references to <231> from USP-NF monographs also will be official as of December 1, 2015.

问：是否一旦通论<232>和<2232>开始应用，通论<231>就应该被忽略？

答：自2015年12月1日通论<232>和<2232>开始应用，USP通论<231>就应该被忽略。同日USP也会取消USP-NF中对<231>的引用。

7.       Can manufacturers work with USP on a specific product that may not meet the limits of a particular element?

USP hopes to work with FDA and with individual manufacturers on resolving scientific issues arising from the new Elemental Impurities requirements, balancing manufacturer interests with public health impact. Upon receipt of the appropriate supporting information. USP may proposed a revision to the monograph to address its special requirements. Such requirements in a monograph, should the monograph be approved and become official, would take precedenence over the requirements specified in <232> or <2232>.

问：生产商是否可以与USP合作，讨论可能无法符合特定的元素标准的特殊的药品规格？

答：USP希望与FDA合作，针对单个生产商，解决其在新的元素杂质要求方面的科学问题，寻求生产商利益与公众健康影响之间的平衡。在收到适当的支持性资料后，USP可以提议对各论进行修订以反映其特殊要求。这种情况下，在物质各论中被批准并生效的标准，优先于通论<232>或<2232>的标准。

Revision history 修订历史

Version 3: December 27, 2013

版本号3：2013年12月27日

l         General revisions to FAQs as part of the announcement of the December 1, 2015 date of applicability of General Chapters <232> and <2232>

l         作为通论<232>和<2232>应用日期（2015年12月1日）公告的一部分，对常见问题进行常规修订

Version 2: June 7, 2013

版本号2：2013年7月7日

l         Added FAQs 增加常见问题

n         “What is a “deferral” and what are the possible outcomes?”

n         什么是“延期”？可能是什么后果？

n         ‘How will the Advisory Group be formed? Who will be its members?”

n         顾问组如何组建？谁能成为组员？

l         Revised FAQ 修订常见问题

n         Will General Chapter <231> still be applicable to veterinary monographs?

n         通论<231>是否还适用于兽药各论？

l         Omitted FAQ 删除常见问题

n         “What does USP plan to do with other general chapters that address elemental impurities such as <251> Lead, <211>Arsenic and <261> Mercury, etc.?”

n         USP准备怎么处理关于元素杂质的通论如<251>铅、<211>砷和<261>汞等？

Version 1: May 29, 2013

版本号1：2013年5月29日

n         Initial version posted

n         首版公开

怀谷

谢谢楼主！

dumbness

楼主好强大，感谢分享