• PDA TR 39

PDA TR 39

Technical Report No. 39, (TR 39), Revised 2007, Guidance for Temperature-Controlled Medicinal Products: Maintaining the Quality of Temperature-Sensitive Medicinal Products through the Transportation Environment

Parenteral Drug Association , 2007

Publisher: PDA

File Format: PDF

$162.00$325.00


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.

PDA TR 39 History

PDA TR 39

PDA TR 39

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PDA TR 39

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$162.00 $325.00

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