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USP is Revising its Compendia in Response to Injectable Product Glass Issues and Plastics Usage

Aug 7th, 2011

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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 beginning on page 2. 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

The series of IPQ stories, which comprises an in-depth report on the current challenges and solutions to glass control for injectable products, can be purchased for $295 by contacting Wayne Rhodes ([email protected]).  Individual stories can be purchased for $95 each.

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