PDA TR 39 PDF

$195.00

Technical Report No. 39 (Revised 2021) Guidance for Temperature-Controlled Medicinal Products – Maintaining the Quality of Temperature-Sensitive Medicinal Products through the Transportation Environment
Report / Survey by Parenteral Drug Association, 2021

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Document Format: PDF

Description

This technical report provides guidance for establishing a quality management system for distribution of all types of temperature-sensitive medicinal and pharmaceutical products, from preparation of products for transportation at shipping sites to the shipment of products to receiving sites for storage or distribution to patients (end users).
The examples accompanying the points to consider provided herein on how to protect the quality of the product are for demonstrational purposes only.

PDA TR 39 PDF

$195.00

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

Document Format: PDF

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.