首页 馆藏资源 舆情信息 标准服务 科研活动 关于我们
现行 PDA TR 39
到馆提醒
收藏跟踪
购买正版
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
本技术报告为建立一个质量管理体系提供了指导,该体系适用于所有类型的对温度敏感的医药产品的分销,从准备在装运地点运输的产品到将产品运输到接收地点储存或分销给患者(最终用户)。在本文中提供的关于如何保护产品质量的考虑点的示例仅用于演示目的。
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.
分类信息
发布单位或类别: 未知国家-其他未分类
关联关系
研制信息
相似标准/计划/法规