20151022 ECA新闻：修订后的USP通论<661>容器---塑料

20151022 ECA新闻：修订后的USP通论<661>容器---塑料

GMP News
22/10/2015

Revised USP General Chapter <661> Containers-Plastics

修订后的USP通论<661>容器---塑料

The revised USP General Chapter <661>  (Containers-Plastics) will be published in USP 39-NF34 with an official date of May 1, 2016.

修订后的USP通论<661>（容器-塑料）将在USP39-NF34中出版，生效日期为2016年5月1日。

Including Changes to the title of General Chapter <661> (new title: Plastic Pckaging Systems and their Materials of Construction), sections of General Chapter <661>  moved into new General Chapters <661.1> (Plastic Materials of Construction) and <661.2> (Plastic Packaging Systems for Pharmaceutical Use). The General Chapter <661.1> gives information on the comprehensive characterization of a plastic material, while General Chapter <661.2> covers testing methods and standards for packaging systems made of plastic.

变更包括通论<661>标题的变更（新标题：塑料包装系统和其构成原料），通论所在位置移到了新的通论<661.1>（塑料原料）和<661.2>(药用塑料包装系统)。通论<661.1>里给出了关于塑料物料的综合定性信息，而通论<661.2>里则包括了塑料制包装系统的测试方法和标准。

The Drafts of the above mentioned General Chapters were proposed for comment in Pharmacopeial Forum 39(5) and 40(5).

上述通论的草案是在药典论坛39（5）和40（5）上公开征求意见的。

All modifications will become official on May 1, 2016.

所有修订都将于2016年5月1日正式生效。

Additionally, a Draft of a new USP General Chapter <1661>  (Evaluation of Plastic Packaging Systems and their Materials of Construction with respect to their user safety impact) was proposed in Pharmacopeial Forum 40(6).

另外，又新起草了一份USP通论<1661>（塑料包装系统及其结构材料对其使用安全的影响）在药典论坛40（6）上公开。

Following your registration on the USP Pharmacopeial Forum  website you can get to the complete Drafts of  USP General Chapters <661>, <661.1> ,<661.2> and <1661>.

在注册USP药典论坛后，你就能获得完整的<661><661.1><661.2>和<1661>草案。

转自：http://zhuyujiao1972.blog.163.com/blog/static/98694727201592210339828/