This Points to Consider document presents a holistic overview for managing raw materials for ATMPs and connects the ATMP material categories, risk-based material qualification including specification setting, risk-based vendor/supplier qualification, and phase-appropriate GMP and control strategy.
PDA is an association made up of and sustained by our member volunteers who contribute their time and expertise to develop a variety of important global consensus documents. Team members are expected to contribute their individual scientific and technical experience to create neutral, scientifically rigorous documents, and should be prepared to participate fully through attendance at team meetings (virtual or in-person when possible) and provide input and content to the document being drafted.
- Process Engineering
- ATMP/Gene and Cell Therapy
- Upload CV
- Current PDA Members only