全球医药供应链的基础冷链物流外文翻译.doc

全球医药供应链的基础——冷链物流外文翻译 Cold Chain Management-An Essential Component of the Global Pharmaceutical Supply Chain Material Source:////0. f Author:Rafik H.Bishara,Ph.D Executive Summary Members of the pharmaceutical supply chain have various global regulatory requirements to meet while handling, storing, and distributing environmentally sensitive products. Their focus is to provide cold chain management for temperature sensitive pharmaceuticals to ensure that the quality and efficacy of the product will not be compromised. This article reviews the increased importance of pharmaceutical cold chain management as a result of changing product portfolios, there quirements for Good Storage and Distribution Practices, current regulatory trends, quality management, risk assessment factors, and temperature monitoring. Trends include: Responsibility for cold chain management ultimately resides with the manufacturer Increased over sight, management, and control of environmental conditions across the entire supply chainfrom manufacturer to consumer/patient Increased importance of temperature control and monitoring to mitigate and identify risks Heightened priority of patient safety Due to the presence of multiple uncontrolled variables in the distribution process, developing an appropriate temperature and humidity monitoring program is essential to protect the quality of environmental-ly sensitive pharmaceutical product and ensure patient safety. Increased Importance of the Pharmaceutical Cold Chain Of the greater than $400 billion of pharmaceutical products sold worldwide in 2003 approximately 10% or $41 billion were biopharmaceuticals. From 1999 to 2003 the biopharmaceutical market grew at an average annual compound growth rate of 21%-much faster than theroughly 11% for the traditional pharmaceutical market. Given that biopharmaceuticals tend to be temperature sensitive, the cold chain has become an increasingly important component of the overall ph