This Technical Report originally
issued in 2005, provides guidance to the biopharmaceutical/pharmaceutical industry
and regulators on the essential principles and practices for shipment of products
which require controlled temperature during transit. It also provides a design
approach to the development of specialized packages and systems which will protect
temperature-sensitive products during transportation. The 2007 Revision, prepared by PDA Temperature-Controlled Pharmaceuticals Group (TPG) –
Harmonization Task Force has been updated and harmonized to
reflect new global requirements.
2007. Volume 61, Issue No. S-2.
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Table of Contents:
3. Principles of Qualification for
4. Product Stability Profile
5. Transportation Process Flow
6. Design and Development
7. Operational and Performance
8. Process Implementation and Training
12. Global Regulations and
13. Publications from Official Bodies