Technical Report No. 39 (Revised 2021) Guidance for Temperature-Controlled Medicinal Products - Maintaining the Quality of Temperature-Sensitive Medicinal Products through the Transportation Environment
第39号技术报告(2021年修订)温控药品指南——通过运输环境保持温度敏感药品的质量
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.