Drug products can be heavily impacted when raw materials cause variability – anecdotal evidence suggests that batches worth millions of dollars are sometimes discarded due to trace elements coming through the supply chain. This increases costs, significantly impacts...
It is important to continue efforts to understand the sources of trace element variation and implement risk mitigation strategies. End-to-end knowledge exchange, i.e., traceability of the individual components used in a manufacturing process all the way to its...
Through the experience of its members, BioPhorum has defined a best practice approach to the registration of innovative and complex raw materials with major benefits: Increased flexibility of supply through enhanced knowledge and understanding of products and...
Industry has come together through BioPhorum to propose a pragmatic and simple solution to the challenges it faces with the registration of complex and innovative raw materials (RMs) in Europe. The regulatory environment for the registration of innovative and complex...
Change control and periodic re-assessment are an essential part of raw-material lifecycle management to maintain a qualified raw material. In addition, accurate and timely information is also required in risk assessment to identify any raw materials that warrant...
