ECA新闻20150527：新USP章节：药品包装完整性（精彩）

ECA新闻20150527：新USP章节：药品包装完整性（精彩）

2015-05-27 22:51:44

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ECA新闻

GMP News
27/05/2015

New USP Chapter on the Integrity of Pharmaceutical Packaging

新USP章节：药品包装完整性

The Pharmacopoeial Forum (PF) 40(5) from September / October 2014 comprised new proposals of the USP with regard to the in-process revision of the General Chapter on the Integrity of Pharmaceutical Packaging Materials.

药典论坛（PF）40（5）自2014年9/10月包括了正在修订的药用包装物料的完整性通论。

In the same issue there is also an explanatory "stimuli article" about the history of the requirements with regard to the integrity of packaging. This article is supposed to facilitate the understanding of the changes planned by the USP.

在相同的问题里，还有一个关于包装完整性要求的历史的“刺激文章”的解释。本文章是为了全球理解USP计划的变更。

So far, there is the General Chapter <1207> on the evaluation of the integrity of packaging materials for sterile products. In the future, the following 4 General Chapters are planned:

到目前为止，有一个通论<1207>是关于无菌药品包装材料完整性评估的。将来，计划会有以下4个通论：

• Sterile product packaging - integrity evaluation <1207>
• 无菌产品包装----完整性评估<1207>
• Package integrity and test method selection <1207.1>
• 包装完整性和检验方法选择<1207.1>
• Package Integrity leak testing technologies <1207.2>
• 包装完整性泄漏检测技术<1207.2>
• Package seal quality test methods <1207.3>
• 包装密封质量检测方法<1207.2>
  

The Chapter <1207> is supposed to provide an outline, the other 3 chapter are planned to cover specific topics in detail.

通论<1207>是要提供一个大纲，其它3个通论计划覆盖特定专题。

Depending on the incoming feedback on these proposals a further revision of these General Chapters will be considered.

根据收到的对这些草案的反馈，对这些通论可能会考虑进一步修订。

For more information on the General Chapters in the revision process please see the Pharmacopeial Forums (PF).

更多关于通论修订中的信息，请参见药典论坛（PF）。

Source: USP

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