良好分销中对温度敏感的药品包装的一般规范和试验方法实践原则

[中文适用范围]： 本文件根据良好分销规范 (GDP) 的原则描述了温度敏感药品包装的一般规范。 它还规定了验证温度敏感药品包装性能的测试方法。 这涵盖了保温容器的温度记录程序和性能测试方法，例如尺寸、重量、存储容量和温度控制的鲁棒性。 本文件不保证所有药品的质量和安全。 特殊情况下，重量或产品特性及环境有特定条件的，按协议规定。 本文档不涵盖主动封装系统，而仅涵盖无需任何电源即可控制所需温度的被动封装系统。 [外文原描述]： This document describes the general specifications of temperature-sensitive medicinal packaging based on the principles of good distribution practice (GDP). It also specifies test methods to validate the package performance for temperature-sensitive medicinal products. This covers the procedures of temperature-recording and testing methods on the performance of insulated containers such as dimensions, weights, storage capacity and robustness in temperature-controlling. This document does not guarantee the quality and safety of all medicinal products. Under special circumstances where the weight or the characteristics of the products and environment show specific conditions, agreements are followed. This document does not cover the active packaging system, but only covers the passive packaging system able to control the desired temperature without any power sources.