This paper discusses background information related to RM regulatory requirements and industry challenges, and then highlights key principles to consider in setting up a risk-based RM management approach and control strategy. This paper then provides an example of how to translate those key principles into a detailed RM risk assessment methodology, and how to apply this methodology to specific raw materials. To better illustrate the diversity and nuance in applying a corresponding RM control strategy, a number of case studies with raw materials typically utilized in the manufacture of biological medicinal products have been included as well as discussion on phase-based mitigations.European Biopharmaceutical Enterprises (2018) “Management and Control of Raw Materials Used in the Manufacture of Biological Medicinal Products and ATMPs“
Good foundation document for how to build a risk management program for managing raw materials.
One thought on “Risk Management of Raw Materials”