(565a) CDER Efforts on Pharmaceutical Manufacturing Modernization

The presentation will start with a brief introduction of the concept of Pharmaceutical Quality, and then will describe CDER’s Quality journey from the early 2000s to the present to promote use of Advanced Technologies in bio-pharmaceutical manufacturing to achieve a higher level of process capability and thus higher product quality assurance. The presentation will discuss most recent efforts at the Agency, internal and external, to develop streamlined processes to facilitate approval of applications implementing new technologies, and to engage with industry and other external stakeholders to solicit their input on how to promote quality manufacturing. These efforts include, but not limited to, implementation of IQA teams and KASA in the assessment process, the Emerging Technologies Program (ETP) and the Framework for Regulatory Advanced Manufacturing Evaluation (FRAME) to facilitate a close collaboration between Industry and Regulators to bring such advanced innovative technologies to bear to enhance product quality assurance. Establishing an appropriate regulatory framework is essential to keep pace with innovation to enable approval of critical and high-quality medicines in a timely and cost-effective fashion by increasing the agility, efficiency and flexibility of pharmaceutical manufacturing and supply chains.