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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 con
17、ditions and the lengths of studies chosen should be sufficient to cover storage, shipment, and subsequent use.” Furthermore,“ data from the accelerated storage condition and, if appropriate, from the intermediate storage condition may be used to evaluate the effect of short-term temperature excursio
18、ns outside the label storage conditionssuch as might occur during shipping.” The Food and Drug AdministrationFDAGuidance on Stability for the industry notes that adverse shipping and/or environmental conditions may affect the product quality. Deficiencies in good distribution practices with specific
19、 focus on temperature control and monitoring during shipment have been cited by the FDA. Several studies by the United States Pharmacopeia USP demonstrated temperature and humidity variations during shipping of drugs and accines. Time and temperature recording devices documented values as high as 60
20、C. The United States Pharmacopeia standards are cited in Good Storage and Shipping Practices. USP describes procedures to maintain proper storage environments for individual articles and ensure the preparations integrity until it reaches the user. Risks associated with distribution routes include ex
21、posure to temperature excursions, humidity, light and oxygen12.Pertinent sections include: Storage in Warehouses, Pharmacies, Trucks, Shipping Docks, and Other Locations, Controlled Room Temperature, Personnel Training, Qualification of “Cold” Equipment or Stores, Distribution and Shipment of Pharma
22、copeial Articles”, “Qualification Protocol” , “Temperature Challenges”, “Receipt of Pharmaceutical Articles”, “Distribution or Shipping Vehicles”, “Vehicle Qualification”, “Pharmaceutical Delivery Staff”, “Shipment from Manufacturer to Wholesaler”, “Shipment from Manufacturer or Wholesaler to Pharma
23、cy”, “Shipment from Pharmacy to Patient or Customer”, and “Storage of Physician Samples Handled by Sales Representative in Automobiles”. Recently, Health Canada has published guidelines that place greater responsibility on members of the supply chain including manufacturers, distributors, transporte
24、rs and retailers to ensure that the drug products will reach the customer uncompromised. The key concepts presented in the European Union Guidance on Good Distribution Practices include:“ The quality system operated by distributorswholesalersof medicinal products should ensure that storage condition
25、s are observed at all times, including during transportation” and “products requiring controlled temperature storage should also be transported by appropriately specialized means.” Regulatory Trends In recent years, global regulatory agencies have increased oversight to ensure the integrity of pharm
26、aceutical products in the distribution chain. Although USP Good Storage and Shipping Practices, referenced above, had previously been published as an “in-process revision” it was recently published as a “general chapter” in the USP NF 2 Supplement on August 1,2005.This document in conjunction with r
27、egulatory guidances to industry, recent presentations by industry thought-leaders, and regulatory enforcement citations, outlines several common trends impacting cold chain management. These trends include: A. Responsibility for cold chain management ultimately resides with the manufacturer. B. Incr
28、eased oversight, management, and control of environ-mental conditions across the entire supply chainfrom manufacturer to consumerfor temperature sensitive pharmaceutical products. C. Increased importance of temperature control and monitoring to mitigate and identify risks during cold chain transport
29、. D. Heightened priority of Patient safety. Quality Management System In order to keep up with the above mentioned global regulatory requirements and trends, a quality management systemQMS and risk assessment process become essential. Factors to be considered for the QMS may include but are not limi
30、ted to the: Organization, roles and responsibilities, process, trained resources, implementation plan, compliance, change control, on-time, delivery of right product, quality metrics, continuous enhancements, and monitoring customer satisfaction. Risk Assessment Process Complementing the QMS for goo
31、d distribution practices is an ongoing risk assessment process. Areas to be assessed include: compliance with regulations,guidances and quality standards, product profile, physical and chemical stability, environmenttemperature mapping, temperature control, temperature and humidity monitoring, mode
32、of transportationground, air, sea, shipment destinationdomestic, export,packageprimary and secondary, peoplestandard operating procedure, training, communication, documentation, recognizing, addressing, correcting adverse events, and change controls. Temperature Monitoring System In a recent confere
33、nce on Cold Chain Management for pharmaceuticals, a speaker from the United Kingdoms Medicines and Healthcare Products Regulatory AgencyMHRAstated:“ Each shipment between countries and within countries of large geographical area should be treated as unique in terms of the range of temperatures the g
34、oods may experience.” Conclusion Global regulatory requirements for the handling, storage, and distribution of thermally labile pharmaceutical products have emphasized the importance of assuring that product quality and integrity are not compromised in the distribution channel. New guidances outline
35、 a comprehensive view of cold chain management across the supply chain including: manufacturers, warehousers, distributors, transporters, and retailers. Trends of recent regulatory inspection citations demonstrate an increased focus on the factors affecting these labile preparations and ensuring the
36、ir quality and integrity. Due to the presence of multiple uncontrolled variables in the distribution process, developing an appropriate monitoring program is essential.译文全球医药供应链的基础?冷链物流 资料来源:/. 作者:哈里阁下比沙拉博士 摘要 医药供应链对每个环节都有不同的要求,在符合全球法规的条件了,处理、储存、运输哪些对环境敏感的医药用品。冷链物流在医药中的运用的重点就是提供对温度敏感的药品,以确保药品的质量和效果不
37、会受到影响。 这篇文章回顾了在制药管理中冷链,由于改变产品组合,商品储藏最小需氧量及投资惯例,现行管理趋势,质量管理,风险评估因素,和温度监控上,其不断增长的重要性。 趋势包括: 1.冷链管理的职责,最终是要由供应商来承担。 2.增加了多视角管理以及涉及整个供应链(从制造商到消费者/病人)中的环境控制。 3.加强温度控制的重要性,并且增加监测,以此来识别风险和减轻风险。 4.把病人的安全放到第一位。 由于在分销过程中存在多个无法控制的不定因素,保证适当的温度和湿度的监测方案必须马上成立,保证对环境敏感的药品质量,更加要保证患者的安全。 日益重要的药品冷链 2003年大概超过400亿美元的药品销
38、往世界各地,其中约有10%也就是41亿美元的药品属于生物药品。从1999年到2003年生物制药市场的平均年复合增长率为21%,远远高于传统医药市场的年复合增长率。传统医药市场的年复合增长率为11%。鉴于生物制药往往对外部环境非常敏感特别是对温度的要求,所以冷链已经成为整个药品供应链中日益重要的组成部分。 以生物制药市场为重点的投资及管理的增长是由于一系列因素,包括:一家生物制药公司把一个显著的却未能被满足的需求为目标的能力,相比较而言的质优价高的产品定价(策略),以及抵制一般的侵蚀的能力。虽然业界预测各不相同,但是分析公司的报告一致认为,一个新兴的生物制药市场将达到了十年来的最高点,就算是一个
39、保守的数据即平均14%的年均增长速度,也就意味着年底达到1000亿美元。 目前冷链医药物流的监督管理要求 需要控制温度的药品的储存环境是必须被分开放置,以确保其质量不会受到影响。以下是重点监管和产业相关冷链指导的概述。其中内容涵盖包括了来自世界卫生组织,国际协调会议,食品和药物管理局,美国药典,健康加拿大和欧盟的材料。 世界卫生组织(WHO)的好的销售工作规范(GDP)的一个文件?QAS/04.068中的管理条例,他适用于所有的人,在涉及医药产品经销公司时,包括:“成品的中间体和成品制造商,经纪商,供应商,经销商,批发商,贸易商,运输各公司,货运代理,加工。”世界卫生组织发布的文件表明,分配过
40、程已普遍被“忽视”其中被忽略的部分包括:“建立,发展,维护和对参与活动的控制。”此外,由于医药供应链分销事业涉及多个当事人,导致冷链医药物流所涉及的风险变得复杂。正如在世界卫生组织在工作文件?QAS/04.068中所发布的:“为了维持原有品质,在制药产品投资中的每一项活动,都理应根据药品生产质量管理规范,良好存储管理规范,良好销售总值的规则来执行。”世界卫生组织发布的工作文件?QAS/04.068表明:“药物产品应贮存条件下进行评估(在适当的公差),可测试的热稳定性,稳定性和,如适用,其敏感性水分或溶剂损失的可能性。特别是在运输过程中储存条件(相对温度和相对湿度)的要求,这些都是应该提供,检查
41、,监测和记录。”世界卫生组织还表示:“保温车应该保证车内温度的均匀性。记录下来的温度的监测数据应供审查。”这些要求主要是为了:“确保在分配过程的所有医药产品的质量和的完整性。” 正如在关于国际协调会议的文件(ICH Q1AR2)中表明:“药物产品应贮存条件下进行评估(在适当的公差),可测试的热稳定性,稳定性和,如适用,其敏感性水分或溶剂损失的可能性。储存条件和所要精心挑选的研究(范围)应该被仓储,运输,以及随后的使用所充分的涵盖。”此外,“从储藏条件和加速时的贮存条件中得来的数据,如果合适就可用于评估外标签贮存条件(如运输过程中可能发生的)短期温度变化的影响。 美国食品和药物管理局(FDA)的
42、指引保证了业界的稳定。不利的航运和运输环境条件可能会影响运输药品的质量。运输途中的温度监测已经被美国食品和药物管理局(FDA)引用。 由美国药典(USP)的一些研究表明在药物和疫苗的运输时温度和湿度的变化,时间和温度的记录装置的记录值最高为60摄氏度。 监督管理趋势 近年来,全球性的监管机构的权利已经升级至监督,以确保药品在销售的安全.虽然美国药典中有良好的储存和运输惯例,上面提到的完整性,以前被视为“在进程修订版”现在在使用的是最近出版的“总章”中的美国药典的补充。概述了几种冷链管理常见的趋势影响。 这些趋势包括: 1.冷链管理的职责,最终是要由供应商来承担。 2.增加了多视角管理以及涉及整
43、个供应链(从制造商到消费者/病人)中的环境控制。 3.加强温度控制的重要性,并且增加监测,以此来识别风险和减轻风险。 4.把病人的安全放到第一位。 质量管理体系 如果要符合上述提到的全球监管要求和趋势,质量管理体系(QMS)和风险评估过程变得至关重要。其中考虑的因素包括质量管理体系但也不限于:组织,角色和职责,流程,培训资源,执行计划,遵守条例,变更控制,准时,合适的产品,质量指标,持续改进,顾客满意和监测交付。 风险评估过程 质量管理体系中添加更好的销售方法是一个可持续的风险评估过程。评估的范围包括:遵守法规的指导和质量标准,产品介绍,保证产品物理和化学的稳定性,控制环境(温度测绘,温度控制
44、,温度和湿度监测),交通(陆运、空运、海运)运输目的地(进口、出口),人事(标准、操作程序、培训、交流、文档分类、识别、处理、纠正不良事件和控制变更)。 温度检测系统 来自英国的医药和保健产品监管署(MHRA)的发言者在一次对冷链管理药品的最近一次会议中表示:“每个国家和地理区域之间各国的大型货物的温度控制应该是独立的。 结论 全球管理要求在处理、存储、及热不稳定药品销售上强调确保产品质量和完整的重要性不在销售渠道里受到损害.新的指导为一个冷链管理横跨供应链的全面观点拟定的大纲包括了:制造业、批发商和零售业。近期调整的审查引用趋势说明不断强调影响这些易变配制品和确保他们质量和完整性的因素。由于在销售过程中那些多种不易控制的可变性实物的存在,是的发展一项适当的监控计划变得很必要。
