2079210

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

Report / Survey by Parenteral Drug Association , 2007

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Full Description

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.
 

Product Details

Published:
2007
Number of Pages:
29
File Size:
1 file , 650 KB
 

Document History

  1. PDA TR 39


    Technical Report No. 39 (Revised 2021) Guidance for Temperature-Controlled Medicinal Products - Maintaining the Quality of Temperature-Sensitive Medicinal Products through the Transportation Environment

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    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

    • Historical Version