The particulate and reactivity issues that have been surfacing involving drugs and biologics in glass containers and the increased interest in polymer alternatives are prompting USP to revise and expand its related compendial standards and guidance.
USP’s Packaging, Storage and Distribution Expert Committee is rewriting seven general chapters on packaging materials and creating two new ones in response to the increased concern with product/container interactions and the increasing use of plastics. The new general chapters being developed will cover extraction studies and plastic materials, respectively, and the existing chapter on the “Evaluation of Inner Surface Durability of Glass Containers” (<1660>) will be overhauled in line with the new chapters.
At a one-day “Glass Container Delamination Scientific Symposium” sponsored by the pharmaceutical supply chain consortium Rx-360 in late May in Arlington, Virginia, industry consultant Michael Eakins, who is Vice-Chair of the USP Packaging, Storage and Distribution Expert Committee, emphasized that recent events have elevated the importance of these changes to the “highest priority” in the view of USP senior management.
The Rx-360 symposium followed a two-day conference on the emerging concerns with glass quality, co-sponsored by PDA and FDA at the same location.
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