A sharp uptick in the number of sterile product recalls due to glass breakage, defects and delamination have the industry, their glass suppliers, and FDA taking a hard look at the reasons for the increase and what can be done to reverse the trend.
At a two-day PDA/FDA “Glass Quality Conference “ in late May in Arlington, Virginia, and a one-day follow-up forum sponsored by Rx-360, participants surveyed the available data on the control and compliance problems that drug and biologic manufacturers are experiencing with glass delivery systems. The complexities of glass manufacturing, handling and reactivity were explored with the aim of gaining a better understanding of the relevant issues and charting a course toward addressing them.
At the PDA/FDA conference, Merck Global GMP Systems and Compliance Executive Director Joyce Bloomfield hit on an important concern both to industry and FDA regulators in emphasizing that the recalls “are having a very negative impact on product supply in the domestic and international markets.” Patients are not getting vaccines and other critical medically necessary products, the former FDA investigator stressed, adding that “the cost to industry and the patient is unacceptable.”
Bloomfield noted that over 100 million glass vial and syringe units have been recalled over the past 5 years compared with about two million in the ten years prior to that. In turn, nine warning letters citing glass-related problems have been issued in the past five years, compared with seven during the decade before.
Addressing FDA’s view of the glass-related issues, CDER Compliance Office Domestic Case Management Branch Team Leader David Jaworski did not offer a ready explanation for the recall upsurge.
“We are always wondering why we have a significant number of recalls of products,” he said. Even with FDA’s preapproval inspection review and the processes that firms have put in place to minimize defects, “we still have recalls.” He added that “it is interesting to see what is going on” from the industry perspective.
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