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

Parenteral Drug Association , 2021

Publisher: PDA

File Format: PDF

$162.00$325.00


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 History

PDA TR 39

PDA TR 39

$162.00 $325.00

PDA TR 39

PDA TR 39

$162.00 $325.00

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