NEW PARADIGM OF BUILDING QUALITY DURING MANUFACTURE - CHALLENGES WITH BIOLOGICAL PRODUCTS

Dr Rajesh K. Gupta, Biologics Quality & Regulatory Consultants, LLC |
Historically, the quality of biological products has been ensured through testing representative samples. The shift in quality paradigm started with the implementation of Good Manufacturing Practice (GMP) regulations with the current focus on building quality during manufacture. Inherent variability and complexity of biological products pose challenges in implementing the quality by design (QbD) concept. This presentation discusses ways to build quality during the manufacture of biological products.