|
| |
|
Return to introduction |
Advances in Large Scale
BioManufacturing and Scale-Up Production
A Comprehensive Study of the Science,
Technology and Business of Biopharmaceutical Manufacturing.
Published by the ASM Press [American
Society for Microbiology] and the Institute for Science and Technology
Management, Washington, DC, October 2004.
Click below to order:
Advances in Large Scale BioManufacturing and Scale-Up Production |
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.
|
|
Return to introduction |
Advances in Large Scale
BioManufacturing and Scale-Up Production
A Comprehensive Study of the Science,
Technology and Business of Biopharmaceutical Manufacturing.
Published by the ASM Press [American
Society for Microbiology] and the Institute for Science and Technology
Management, Washington, DC, October 2004.
Click below to order:
Advances in Large Scale BioManufacturing and Scale-Up Production |
| |
|
