New USP Chapter on the Integrity of Pharmaceutical Packaging
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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.
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.
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:
- Sterile product packaging - integrity evaluation <1207>
- Package integrity and test method selection <1207.1>
- Package Integrity leak testing technologies <1207.2>
- Package seal quality test methods <1207.3>
The Chapter <1207> is supposed to provide an outline, the other 3 chapter are planned to cover specific topics in detail.
Depending on the incoming feedback on these proposals a further revision of these General Chapters will be considered.
For more information on the General Chapters in the revision process please see the Pharmacopeial Forums (PF).
Source: USP
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