PDA TR 39 that was 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.
- Published:
- 2007
- Number of Pages:
- 29
- File Size:
- 1 file , 650 KB
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