EBE Concept Paper – Management and Control of Raw Materials Used in the Manufacture of Biological Medicinal Products and ATMPs
Brussels, 17 December 2018
Effective management and control of raw materials (RM) used in the manufacture of biological medicinal products including advanced therapy medicinal products (ATMPs) requires an appropriate framework to identify and focus on critical aspects that must be addressed from a quality, regulatory and business perspectives. There are currently no written industry guidelines available with detailed discussion on how to construct such a risk-based RM management approach and control strategy. The purpose of this concept paper is to provide such guidance by leveraging current practices and experiences of the EBE member companies.
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 including ATMPs are provided as well as discussion on phase-based mitigations.
The included examples of risk assessment methodology and model RM case studies are intended to demonstrate how an effective RM management and control plan could be structured. However, although the overall principles are considered key to all companies, alternative implementation approaches related to RM risk assessment methodology and RM control strategy may be equivalently applicable and more suitable for a particular individual company.
Read the full concept paper here.