A BioPhorum member only survey gathering feedback on initial submission Biologics License Applications (BLA) / Marketing Authorization Application (MAA) supplement/variation, etc.) and the outcome of health authority review and approval of the submission.
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Raw materials: Patient-centric requirements for the supply of raw materials
Jun 2015 | Drug Substance, POI - Supply Partner, Raw materials, Supply Partner
Raw material variability and control in the supply chain are important matters for the biopharmaceutical industry. The industry is still working to align the supply performance with biopharma’s needs. More still needs to be done to understand, monitor and control of raw materials. Patient well-being is best assured by reducing or eliminating variability of the finished drug product, and this can be achieved, in part by targeted reduction and/or elimination of variation in raw materials. This paper identifies ten areas of practice endorsed by leading global biopharmaceutical manufacturers to start to address and reduce raw material variation through our supply chains.