The development life cycle of a therapeutic is often well documented and understood. Manufacturing the same therapeutic prior to patient administration is often a complex and challenging proposition, more so for cell and gene therapy products. Good Manufacturing Practices (GMP) guidelines are strictly adhered to, by manufacturing facilities worldwide and Quality Systems within such facilities are of paramount importance.
This resource provides a good overview of Quality Systems from a GMP Manufacturing perspective for Cell & Gene therapy products.
You will learn about:
- Quality assurance (QA) and quality control (QC) processes
- GMP document and change control
- The importance of inspection and audit management, supplier qualification and contamination control
If you intend to understand manufacturing processes for cell and gene therapy products, this resource serves well.