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.
[The story on the USP glass initiatives continues for subscribers here. For subscription/license information, click here.]
See related stories:
Amgen Glass Lamellae Investigation Sheds Light on Biopharma’s Control Challenges and Solutions
Industry/Regulator Forums Point to Role of Glass Suppliers in Injectable QbD
Breakage and Particle Problems in Glass Vials and Syringes Spurring Industry Interest in Plastics
Drug Industry Survey Reveals Wide Disparity in Approaches to Controlling Glass Quality
Sharp Uptick in Recalls for Glass Lamellae Problems Under Scrutiny
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