General Chapter <1660> Evaluation of the Inner Surface Durability of Glass Containers Posted for Comment
USP is seeking comments on General Chapter <1660> Evaluation of the Inner Surface Durability of Glass Containers, which will appear in Pharmacopeial Forum (PF) 38(4). This new general information chapter is posted here in advance of publication in PF to provide stakeholders adequate time to review and comment.
In response to recent product recalls that have further increased the pharmaceutical industry’s awareness of glass quality and glass delamination (i.e., the formation of glass flakes in a vial), USP is proposing this new general information chapter to recommend approaches to predicting potential formation of glass particles and delamination.
The deadline for submitting comments on proposals in PF 38(4) is September 30, 2012. Comments should be submitted to Desmond Hunt, Ph.D., Senior Scientific Liaison (301-816-8341 or firstname.lastname@example.org).