Phacilitate Report Regulatory Considerations for Raw Material Quality and Testing

Roundtable Report: Regulatory Considerations for Raw Material Quality and Testing

This report derives from a roundtable discussion, lead by FujiFilm Irvine Scientific at Phacilitate Leaders World 2020
Our industry is experiencing an increase in regulatory requirements for raw materials due to therapies advancing to clinical phases.

The quality and safety of raw materials from biological origin (e.g. serum, growth factors, cytokines, antibodies, and enzymes) must be documented and available for regulatory reviews while seeking approvals. At a recent discussion at Phacilitate Leaders World in Miami, led by Marlin Frechette, Sr. Director of QS/RA/Compliance Officer a question was posed:
 
"What are the regulations and requirements that raw material suppliers need to understand to develop commercially viable advanced therapies?"

 
Roundtable Report: Regulatory Considerations for Raw Material Quality and Testing
 
 
This three-chapter report of the discussion encompasses formulation information, supply chain and risk mitigation and regulatory harmonisation, with additional research and resources:
  1. Formulation information
  2. Supply chain and risk mitigation
  3. Regulatory harmonisation