《PDA TR39》.pdf

Technical Report No. 39 Cold Chain Guidance for Medicinal Products: Maintaining the Quality PDA Journal of of Temperature-Sensitive Medicinal Products Pharmaceutical Through the Science and Transportation Technology Environment September/October 2005 Supplement Volume 59 No. S-3 PDA Technical Report No. 39 Cold Chain Guidance for Medicinal Products: Maintaining the Quality of Temperature- Sensitive Medicinal Products Through the Transportation Environment PDA Cold Chain Management Task Force Rafik H. Bishara, Ph.D., Eli Lilly and Company—ret. Teresa Lucas, Eli Lilly and Company (Chair and contact person) Sarvang Mishra, Wyeth Jim Antonopoulos, sanofi pasteur Kevin O’Donnell, Abbott Laboratories Mari Bakken, Abbott Laboratories Oumer Salim, Wyeth Daniel Colton, Genentech Inc. Jeff Seeley, Merck Co., Inc. Laura Fontan, Human Genome Sciences Bob Seevers, Ph.D., Eli Lilly and Company Derrick Gallagher, Sanofi-Aventis Edward G. Smith, Ph.D., Wyeth Paul Harber, Eli Lilly and