RAQA - Gowri Sukumar-Setting API Specifications
Today we roll out another RA/QA Today podcast episode featuring Ms. Gowri Sukumar who is the Director of CMC and Regulatory Affairs for Betacat Pharmaceuticals in Houston, TX. Gowri has a breadth of experience spanning across R&D, CMC, and Regulatory Affairs. Simultaneously, she serves a reviewer for several Bioscience journals across the world. The topic we covered is "How to set specification limits for impurities in active pharmaceutical ingredients (API)." Some of the items we cover in the episode: -The first step to setting these specifications -The most important tool to setting this specification -What is acceptable and what is not considered acceptable specifications ...and so much more