Pharmaceutical manufacturers are beginning to probe deeper into the glass integrity threats to injectable products occurring downstream at the wholesale and specialty pharmacy levels, beyond their traditional reach.
Amgen – a firm that has been very actively involved with exploring all aspects of glass manufacturing and handling following its recall problems resulting from glass delamination – has been taking a lead role in pushing into this downstream arena as a not well-understood but very real additional threat to injectable products marketed in glass containers.
The risks that can occur to products after leaving direct manufacturer control were addressed at a PDA/FDA glass conference in Washington, DC in early June by Amgen Package Engineering and Labeling Senior Manager Shana Whitmore, who detailed the firm’s findings and resulting actions.
The focus of the Amgen report, in turn, represented a notable expansion in scope from the first PDA/FDA glass conference and a follow-up one-day Rx-360 forum held a year earlier (links to the series of six stories in IPQ’s coverage of the 2011 meetings are provided below).
[The story on the 2012 conference continues for subscribers here. Nonsubscribers can purchase the story for $195 by contacting Jonathan Trethowan (Jonathan@ipq.org). For subscription/license information, click here.]
See related stories:
Amgen Glass Lamellae Investigation Sheds Light on Biopharma’s Control Challenges and Solutions
USP is Revising its Compendia in Response to Injectable Product Glass Issues and Plastics Usage
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
Industry/Regulator Forums Point to Role of Glass Suppliers in Injectable QbD
