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

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  • Description
  • Table of Contents

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:

1. Introduction
2. Glossary
3. Principles of Qualification for Transport
4. Product Stability Profile
5. Transportation Process Flow Considerations
6. Design and Development
7. Operational and Performance Qualification Testing
8. Process Implementation and Training
9. Quality Systems
10. Handling
11. Conclusion
12. Global Regulations and Pharmacopoeial Standards
13. Publications from Official Bodies
14. Tables

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