Regulatory Considerations for Raw Material Quality and Testing
Jul 24, 2020| Posted in Cell & Gene Therapy, Corporate
What are the regulations and requirements that raw material suppliers need to understand to develop commercially viable advanced therapies? In a discussion led by Marlin Frechette, Corporate Compliance & Quality Officer (CQO), FUJIFILM Irvine Scientific, top regulatory experts explore key considerations for manufacturers:
- Formulation information—Manufacturers need adequate, reliable information on raw materials. What are the workarounds manufacturers can use to address the issue?
- Supply chain—Supply chain risks can lead to devastation. What can manufacturers do to mitigate risk and ensure consistent supply?
- Risk mitigation and regulatory harmonization—How can developers and manufacturers better protect their supply chain? How can they improve their understanding of the regulatory requirements across key regions?
Read the roundtable report to gain key insights into these topics and the factors that play integral roles in developing commercially viable advanced therapies and bringing them to market.