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1、全球医药供应链的基础冷链物流外文翻译 外文翻译原文Cold Chain Management-An Essential Component of the Global Pharmaceutical Supply ChainMaterial Source:/0. fAuthor:Rafik H.Bishara,Ph.D Executive Summary Members of the pharmaceutical supply chain have various global regulatory requirements to meet while handling, storing, an
2、d 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 mana
3、gement 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 ma
4、nufacturer 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
5、 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 C
6、hain 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 p
7、harmaceutical market. Given that biopharmaceuticals tend to be temperature sensitive, the cold chain has become an increasingly important component of the overall pharmaceutical supply chain The increased investment and management focus on the biopharmaceutical market is due to a number of factors i
8、ncluding: a biopharmaceuticals ability to target a significant unmet need, premium pricing relative toother products, and limited generic erosion. While industry forecasts vary, analyst firm ASInsights reports an emerging consensus that the bio-pharmaceutical market should reach$100 billion by the e
9、nd of the decade-implying a conservative average annual growth rate of 14%. Current Regulatory Requirements Medicines requiring controlled-temperature storage conditions mustbe distributed in a manner that ensures their quality will not be adversely affected. Following is an overview of key regulato
10、ry and industry guidance related to cold chain management. Content covered includes material from World Health Organization, International Conference on Harmonization, Food and Drug Administration, United States Pharmacopeia, Health Canada, and the European Union. The World Health OrganizationsWHO w
11、orking document QAS/04.068 on Good Distribution PracticesGDP is applicable to all per-sons and companies involved in the distribution of pharmaceutical products including the:“ manufacturers of intermediate and/or finished products, brokers, suppliers, distributors, wholesalers, traders, transport c
12、ompanies, forwarding agents, processors, etc.” This WHO document indicates that the distribution process has generally been “neglected” regarding the:“ establishment, development, maintenance and control over the activities involved.” Further, because the distribution segment of the pharmaceutical s
13、upply chain involves multiple parties, the risks involved become complex. As stated in theWHOworking documentQAS/04.068:“In order to maintain the original quality, every activity in the distribution of pharmaceutical products should be carried out according to the principals of GMP, Good Storage Pra
14、cticeGSPand Good Distribution PracticeGDP.” TheWHOworking document QAS/04.068 states:“ where special storage conditions e.g. temperature and relative humidityare required during transit, these should be provided, checked, monitored and recorded.” It goes on to state: “Temperature mapping of vehicles
15、where applicableshould support uniformity of the temperature across the vehicle. Recorded temperature monitoring data should be available for review.” The overall bjective of these guidelines is to:“ ensure the quality and integrity of pharmaceutical products during all aspects of the distribution p
16、rocess.” As stated in the International Conference on Harmonization document ICH Q1AR2:“a drug product should be evaluated under storage conditionswith appropriate tolerancesthat test the thermal stability and, if applicable, its sensitivity to moisture or potential for solvent loss. The storage conditions and the lengths of studies chosen should be sufficient to cover storage, shipmen
