FDA and Regulatory Issues in Biopharmaceutical Manufacturing
Manufacturing and scale up of medical products have raised regulatory issues in the US for at least 100 years. Today a medical product faces issues related to manufacturing and scale up from the moment it is designated as a candidate to move beyond the laboratory. These research products and their sponsors face regulatory issues during every phase: the move from Good Laboratory Practices, to clinical use in humans, to manufacture of small Phase I batches, through technology transfer, to Phase III scale up and post marketing changes. The regulatory issues demand attention at every stage in order to prevent holds and even study termination. The procedures, and quality records that document them, serve as the eyes and ears for the company, its investors, its quality unit, and for the public health. As such, these records are subject to scrutiny by the Food and Drug Administration and increasingly by shareholders; they take on that much more importance. This chapter addresses the systems that must be in place to reduce the chances that FDA will interrupt product development at these milestones, and identifies the requirements likely to be carried over to the new programs. It also includes additional resources for further information.
About the Authors
Andrea E. Chamblee, Esq., RAC
Johns Hopkins University, Maryland
Ms. Chamblee works with interdisciplinary professional teams on issues regarding regulated products. She is a Food and Drug Attorney, regulations and compliance expert, agency liaison, instructor for Fundamentals of FDA Regulation at Johns Hopkins University. She analyzes laws and regulations on FDA and administrative law issues and on product regulation from concept to commercialization. She prepares FDA submissions, and is trained as an FDA inspector, editor, writer. She was admitted to the MD Bar in 1986 and the DC Bar in 1989. Ms. Chamblee is Regulatory Affairs Certified by RAPS and won a RAPS special recognition award in 2003. Chamblee is licensed to practice in DC and MD.