The complex issues around glass quality and drug product interactions bring into high relief the need for container suppliers to be directly involved in the implementation of quality by design (QbD) for injectables.
The linkage between the manufacturing of injectable containers and the control of the drug and biologic products they contain – and the need for closer communication and scientific cross-fertilization between the suppliers and users to assure that control – have been key themes in the dialogue between industry and regulators prompted by the recent spate of control problems and associated product recalls involving glass breakage, defects and delamination.
Advancing that dialogue was a pair of forums held in late May in Arlington at which experts met for three days to take a hard look at the causes of the problems and where the potential solutions may lie. A two day conference cosponsored by PDA and FDA, focusing more generally on the issues around glass control, was followed by a one-day forum sponsored by the pharmaceutical supply chain consortium Rx-360, which honed down on glass delamination.
At the two forums, pharmaceutical and glass manufacturers and experts from USP and FDA’s review and compliance staff surveyed the available data on glass manufacturing, handling and reactivity and the related control and compliance problems drug and biologic firms are experiencing.
The importance of glass suppliers and pharmaceutical companies working together to transition from a testing to a QbD-based control paradigm was a key theme in the forum discussions.
It was agreed that the scientific, technical and procedural challenges would only be solved with enhanced communication between the glass suppliers and users and the more open sharing of formulation and process information.
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