10/11 March 2021
The USP Packaging and Distribution Expert Committee is proposing the revision of the USP glass container chapters <660> Containers-Glass and <1660> Evaluation of the Inner Surface Durability of Glass Containers.
The drafts of these two chapters have been published for public comment in Pharmacopeial Forum (PF) 43(3) [May–Jun. 2017]. Deadline for comments is July 31, 2017.
The revision of <660> is proposed "to clarify the intent of the chapter and provide additional information to aid in the execution of the Surface Glass Test, Glass Grains Test, and Surface Etching Test".
USP says 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".
Listed below are the key changes being proposed for <660>:
Additionally, the Expert Committee is proposing the revision of <1660> to "clarify the intent of the chapter and provide additional information to aid in the understanding of the factors that affect the inner surface durability of a glass container".
Listed below are the key changes being proposed to <1660>:
Furthermore, minor editorial changes have been made to update the two chapters to current USP style.
A workshop on Modernization of USP Packaging Standards for Glass and Elastomeric Components, will take place from June 19–20, 2017 at the USP Meetings Center in Rockville, Maryland, to discuss these two proposals.
The USP also provided a briefing list in PF 43(3) which includes monographs and/or chapters that both reference the general chapters under revision and require revision to keep references to the General Chapter accurate. The USP says that "other monographs and/or chapters may also be listed, even where the reference to the General Chapter remains unchanged, as additional notice to stakeholders where there is believed to be potential for the change in the general chapter itself to affect pass-fail determinations for particular monograph articles".
Following your registration on the Pharmacopeial Forum website you get access to the complete drafts of general chapters <660> and <1660>.