Risk Management of Raw Materials

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.

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out /  Change )

Google photo

You are commenting using your Google account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s

This site uses Akismet to reduce spam. Learn how your comment data is processed.