Drafts of USP Packaging Chapters to be redeveloped

On 23rd February the United States Pharmacopeia, USP, posted the announcement that the drafts of Packaging Chapters published in Pharmacopeial Forum (PF) 43(3) [May–Jun. 2017] will be cancelled and redeveloped.

This concerns the following packaging related general chapters previously published for comment in Pharmacopeial Forum 43(3): 

  • <660> Containers —Glass
  • <1660> Evaluation of the Inner Surface Durability of Glass Containers
  • <381> Elastomeric Closures for Injections
  • <382> Elastomeric Closure Functionality in Injectable Pharmaceutical Packaging/Delivery Systems
  • <1381> Elastomeric Evaluation of Elastomeric Components Used in Pharmaceutical Packaging/Delivery Systems
  • <1382> Assessment of Elastomeric Closure Functionality in Injectable Pharmaceutical Packaging/Delivery

As reported before in USP Draft Chapters on Glass Containers <660> and <1660> the revision was proposed to clarify the intent of these two chapters and to provide additional information to aid in the execution of the Surface Glass Test, Glass Grains Test, and Surface Etching Test in <660> and to aid in the understanding of the factors that affect the inner surface durability of a glass container in <1660>. The reason for the revision of general chapter <381> has been given In a stimuli article Rationale to the revision of USP Chapter <381> Elastomeric Closures for Injections published in PF 43(5) (see also USP Draft Chapters on Elastomeric Closures <381>, <382>, <1381> and <1382>).

A workshop, Modernization of USP Packaging Standards for Glass and Elastomeric Components, was held in June, 2017, at the USP Meetings Center in Rockville, Maryland, to discuss these six proposals. According to USP the revisions were cancelled - based on comments received - pending comprehensive and strategic redevelopment. They will appear on the Cancellations list for the Second Supplement to USP 41–NF 36, which will be posted on April 27, 2018, at USP´s Status-Commentary website.

It is expected that the USP will publish revised proposals for these General Chapters in a future issue of the PF. In the previous proposal for <660> USP already informed that "none of the proposed revisions will change the chapter's requirement. However, there will be a revision proposal in 2018 that is meant to modernize tests, test methods, and specifications within the chapter, and will be a high-impact revision". For more information please see USP`s General Announcement website.

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