New USP Chapter on Package Integrity become official

As reported in previous GMP Newsletters ("New USP Chapter on the Integrity of Pharmaceutical Packaging" and "USP Chapter <1207>: Container Closure Integrity Testing") 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.
 
The same issue also contained an explanatory "stimuli article" about the history of the requirements with regard to the integrity of packaging. 

So far, there is the General Chapter <1207> on the evaluation of the integrity of packaging materials for sterile products. The original content of the chapter has been extensively revised and also subdivided into four related chapters.

With the first supplement to USP39-NF34 the following four General Chapters will become official on August 1, 2016:

  • Sterile product packaging - integrity evaluation <1207>   (Revision)
  • Package integrity and test method selection <1207.1>   (New)
  • Package Integrity leak test technologies <1207.2>          (New)
  • Package seal quality test technologies <1207.3>            (New)   

The Chapter <1207> is supposed to provide an overview of "leak test" technologies as well as "package seal quality tests" useful for verification of sterile product package integrity. More detailed recommendations for the selection, qualification, and use of leak test methods are presented in the three subchapters that cover specific topics in more depth.
 
For more information on the General Chapters please visit the Pharmacopeial Forum (PF).

Source: USP

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