GMP or Not? Understanding Raw Material Quality Grades and Requirements for ATMP Manufacturing
The concept of 'raw material quality grade' is a critical topic for cell and gene developers, yet there is currently significant confusion and misunderstanding surrounding it. While regulatory bodies provide guidance on raw material quality and risk assessment, the responsibility for qualifying raw materials ultimately falls on developers.
This webinar will explore key quality standards and terminology for ATMP ancillary and starting materials. It aims to cell and gene therapy developers with the knowledge needed to streamline their sourcing, qualification, and utilization of these materials in ATMP manufacturing.
What You Will Learn:
- Review definitions of GMP/cGMP per regulations
- Explore the applicability of GMP/cGMP to ancillary and starting materials
- Understand key elements of the appropriate quality standards and requirements for ancillary and starting materials