474335 FDA Review Chemist’s Participation in Pre-Approval Inspections: Case Study from Drug Substance Facility
Based on outcomes of the Agency’s pilot integrated PAI program, other inspections were conducted using this paradigm including the recent PAI of a complex drug substance manufacturing facility. Participation on this inspection provided the reviewer with an opportunity to examine the equipment and process closely, to gain a better understanding of the development and optimization of manufacturing process and controls, and in turn allowed the inspection team to identify the CMC-related observations. Furthermore, the firm provided positive feedback regarding the presence of a review chemist on inspection deemed particularly helpful to better understand and improve regulatory submission of future applications. In summary, implementation of this new integrated approach for conducting a PAI has enhanced the efficiency and quality of review process, and improved communication between FDA and industry.
See more of this Group/Topical: Pharmaceutical Discovery, Development and Manufacturing Forum