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FDA related papers:
FDA and Regulatory Issues in Biopharmaceutical Manufacturing
Author: Johns Hopkins University Company:
Andrea Chamblee, Esq., RAC;
Abstract: Manufacturing and scale up of medical products have raised regulatory issues
in the U.S. 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 the 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.
Public Policy White Papers:
More links coming soon
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