MPTX 526: Chemistry Manufacturing & Controls

Instructors: Roger A. Clemens, Dr.P.H., CNS, FACN, FIFT, School of Pharmacy, USC
Frances Richmond, PhD, School of Pharmacy, USC
Course weight: 3 units
Placement: UPCOMING COURSE SCHEDULE

Latest agenda (may be from previous class)

Introduction and Purposes:

The overarching purpose of this course is to provide participants with a firm foundation in the CMC process, from concept to commercialization of a new active pharmaceutical ingredient (API) and product. By the end of the course, students will be expected to demonstrate the following knowledge and understanding in: Packaging, Analytical Methods, Drug Master File (DMF), Impurities evaluation, BACPAC (Bulk Actives Post Approval Changes) rules, Chiral challenges, Stability testing, SUPAC (Scale Up and Post Approval Changes), PACSAS (Post Approval Changes, Sterile Aqueous Solutions), Tests and specifications for novel dosage forms, and IND (Investigational New Drug) Reform. Student application of the above elements will be assessed in the development of a business project. The project will evaluate the key CMC-related components of an ANDA, NDA or IND submission to the FDA, EU or other regulatory agency.