A PDA-sponsored survey of drug and biologic manufacturers reveals a wide disparity among the practices and approaches being taken to ensure the quality of glass vials and syringes and the products they contain.
Areas where practices differ include glass sampling and testing, defect complaint reporting, quality agreements with and auditing of suppliers, and supply chain change management.
The survey also revealed a fair amount of dissatisfaction with glass container quality, which a majority of respondents felt has not been improving. In turn, while the results were blinded, glass suppliers received significantly different ratings in terms of their responsiveness to problems, customer service, and overall glass quality.
About one-third of the respondents indicated that they are exploring using plastic container alternatives and half of these have an active evaluation program in place – mainly for products under development.
A preliminary analysis of the survey results was presented at a two-day PDA/FDA “Glass Quality Conference” in late May in Arlington, Virginia, by Amgen Quality VP Martin Van Trieste.
In addition to playing a leading role in PDA’s supply chain-related initiatives and serving on its board, the Amgen exec was pivotal in the formation of Rx-360 – an international consortium dedicated to enhancing pharmaceutical supply chain quality.
At the conference, participants examined the available data on the control and compliance problems that drug and biologic manufacturers are experiencing with glass container systems, with the aim of gaining a better understanding of the relevant issues and charting a course toward addressing them.
The recent upsurge in glass particulate-related recalls (IPQ “In the News August 3) indicates that “something has changed,” Van Trieste said in his introductory remarks, adding that the intent of the survey and the conference was to help “tease that out.”
He stressed that the expectation from regulators is that pharmaceutical companies and glass container manufacturers will “work together collaboratively” to find solutions that will benefit patients.
Van Trieste discussed several of the responses to 70 survey questions that he felt would be “most interesting” to the conference participants. These related to: ● glass suppliers ● testing and sampling ● complaints, defect reporting and recalls ● alternatives to glass, and ● supplier quality agreements and auditing.
[Van Trieste’s analysis of the PDA survey results and their implications for glass manufacturers and users is provided 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
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
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 Jonathan Trethowan (Jonathan@ipq.org). Individual stories can be purchased for $95 each.
