元素杂质：USP宣布<232>和<2232>生效日期

20150128 ECA新闻：元素杂质：USP宣布<232>和<2232>生效日期  

2015-02-03 23:42:09|  分类： ECA新闻

GMP News

28/01/2015

Elemental Impurities: USP announces the Date of Entry into Force of Chapters <232> and <2232>

元素杂质：USP宣布<232>和<2232>生效日期

On 14 January 2015 - just 2 days after the adoption of the "Guideline for elemental impurities - Q3D" by the CHMP - the USP announced the date for the validity of the General Chapters <232> (Elemental Impurities - Limits) and <2232> (Elemental Contaminants in Dietary Supplements).

在2015年1月14日—仅仅在CHMP采纳“元素杂质指南—Q3D”之后2天—USP宣布了通论<232>（元素杂质—限度）和<2232>（膳食补充剂中的元素污染物）的生效日期。

Both chapters will be applicable as of January, 1st 2018. This date chosen by USP smoothly follows the date of implementation of the "ICH guideline Q3D on elemental impurities" in the European Member States (1st December 2017). At the same time, the USP published a so-called "Notice of Intent to Revise" which announces the revision of the "General Notices section 5.60.30". In these "General Notices" - which formally set the date for the implementation - you can still find the 1st December 2015, whereas the revised version has included the 1st January 2018. Moreover - according to another "Notice of Intent to Revise" - the abrogation of General Chapter <231> (Heavy Metals) will also be postponed from December, 1st 2015 to January, 1st 2018. Thus, the industry is given the opportunity to keep using this Chapter <231> and the numerous referenced monographs until the deadline on January, 1st 2018.

两个通论均将于2018年1月1日生效。由USP选择的该日期正好在欧盟成员国实施“ICH指南Q3D元素杂质”日期（2017年12月1日）之后。同时，USP公布了所谓的“修订意向通知”，其中宣布了对“通论5.60.30”的修订。在这些“通论”中—之前为其设定的实施日期为2015年12月1日--而修订后的版本则为2018年1月1日才生效。另外，根据另一个“修订意向通知”，通论<231>（重金属）的取消也将从2015年12月1日推迟至2018年1月1日。因此，制药行业在2018年1月1日的期限前仍可以使用该<231>章节以及大量引用该章节的各论。

Further information can be found in a FAQ document about the Chapters <232>, <233> and <2232>. The justification for USP's approach with regard to the revision of the chapters is described in another FAQ document entitled "Rationale for USP's Proposed Standards for Elemental Impurities".

更多信息可以在关于<232>、<233>和<2232>章节的“常见问题”中找到。USP关于修订这些章节的论述则在另一份题为“USP提议的元素杂质标准合理性”的“常见问题”文件中进行了描述。

来源：http://zhuyujiao1972.blog.163.com/blog/static/9869472720151311429725/

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