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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

Report / Survey by Parenteral Drug Association , 2021

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Full 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.

 

Product Details

Published:
2021
ISBN(s):
9781945584299
Number of Pages:
29
File Size:
1 file , 410 KB
 

Document History

  1. PDA TR 39

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

    • Most Recent

  2. 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

    • Historical Version