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1、翻译 PDA TR13 环境监控2015-09-21齐力佳：齐力佳整理1.0 INTRODUCTION简介The purpose of this document is to identifymicrobiological and particulate control concepts and principles as they relateto the manufacture of sterile pharmaceutical products. It expandssubstantially upon the first edition of Technical Report No.
2、13, Fundamentalsof a Microbiological Environmental Monitoring Program, published by PDA in1990. While this publication cannot possibly supplant the wealth ofinformation published on this subject, it provides summary information andappropriate references for the reader to consult, if necessary. The o
3、bjectivewas to contemporize the first edition through the utilization of current definitions,recognition of improved environmental monitoring procedures, and equipment. 本文件目的是确定微生物和微粒控制的概念和原则，因为这涉与到无菌药品的生产。文件全称为第13号技术报告第一版，微生物的环境监测计划基础，PDA于1990年出版。尽管本出版物不可能取代题目的信息价值，它提供了读者查阅必要的主要信息与相关参考。其目的是通过使用当前定义
4、，改善后的环境监测程序和设备来与第一版同步。This document should be considered asguidance; it is not intended to establish any mandatory or implied standard.此文件应作为指南；而不是建立任何强制或隐含的标准。The task force consisted of membersrepresenting global companies, to ensure that the methods, terminology, andpractices reflect the procedur
5、es utilized globally. Technical reviews wereperformed by some of the more prominent environmental monitoring scientists inthe world today. 工作团队由代表全球性公司的成员组成，以确保方法，术语和规程反映了全球围使用的程序。技术审查由一些全球重要的环境监测科学家进行。This document serves as a source on cleanroom environmental test methods, and although some non-vi
6、able particulate andendotoxin testing data are included, its primary focus is microbiologicalcontrol. The concepts for sterile product manufacturing are the most stringentapplication, but these concepts can also be applied to non-sterile productmanufacture. The focus is environmental monitoring as i
7、t relates to facilitycontrol and compliance. This document was compiled to aid in setting up aprogram that is meaningful, manageable, and defendable. 这份文件作为洁净室环境测试方法的来源，虽然包括一些非活性微粒和毒素检测数据，其主要目的是微生物控制。无菌产品生产的概念是最严格的应用程序，但这些概念也适用于非无菌产品的生产。重点是环境监测，因为它涉与到设施的控制和遵守。编写本文件是为了协助建立一个有意义，易于管理且合理的程序。In order to
8、 ensure a consistently acceptableproduction environment, a comprehensive environmental control program should besupported by: (a) sound facility design and maintenance, (b) documentationsystems, (c) validated/qualified sanitization/disinfection procedures, (d)reliable process controls, (e) good hous
9、ekeeping practices, (f) effective areaaccess controls, (g) effective training, certification/qualification andevaluation programs and (h) quality assurance of materials and equipment. 为了确保持续可接受的生产环境，全面的环境控制计划应当得到以下支持：（a）合理的设施设计和维修，（b）文件系统，（c）经验证/合格的杀菌/消毒程序，（d）可靠的工艺控制，（e）良好的车间管理规程，（f）有效面积的访问控制，（g）有效的
10、培训，认证/确认和评价程序和（h）材料和设备的质量保证。Environmental surveillance is a tool utilizedto evaluate the effect of controls on the manufacturing environment. Aprocess to assess the clean room and other controlled environments of apharmaceutical facility can serve as an adjunct to the sterility assuranceprogram for
11、the microbial quality of drugs. The items addressed in thisdocument include definitions, standards, surveillance support systems, systemsurveillance, validation systems, appendices of definitions and typical frequenciesand levels, and a bibliography. 环境监测是用于评价对生产环境控制效果的工具。评估洁净室和其他制药设备受控环境的工艺可作为对药物的微
12、生物质量无菌性保证的辅助方法。本文件涉与的项目包括定义，标准，监督支持系统，系统监控，验证系统，定义和典型频率和等级附录和参考书目。2.0 ENVIRONMENTAL CLASSIFICATIONS环境分级The environmental monitoring program shouldbe designed and implemented based on sound scientific principles, the needfor and the utility of the collected data, and in conformance with theregulatory
13、 requirements of the government agencies regulating the manufacturingsite. Personnel administering environmental monitoring programs should befamiliar with a variety of regulatory schemes if they are to be successful inserving the United States and International product markets. Efforts atharmonizat
14、ion are underway, and it is possible that many of the differences inthe requirements for monitoring programs may disappear as the countries andorganizations involved come to some agreement on the overall approach to betaken. Therefore, it is importantto keep up to date onthe requirements for the dif
15、ferent countries in which the product will be sold. 环境监测程序应根据合理的科学原则，收集到的数据的需求和使用进行设计和执行，符合政府机构监管生产现场的要求。如果人事管理环境监测计划能够成功服务于美国和国际产品市场，应熟悉不同的管理计划。目前正在努力协调，检测计划的要求的差异可能会消失，因为涉与的国家和组织正在协调获得统一的方法。因此，应与时更新产品销往国的要求。This will ensure that the established program meets the monitoringrequirements of each coun
16、try. If the intent is toserve both the United States and the International markets, the most stringentrequirements should be evaluated as the basis of an environmental monitoringprogram. 这将确保既定的程序符合每个国家的监测要求。如果目的是为服务美国和国际市场，最严格的要求应作为环境监测计划的基础进行评估。This section compares published environmentalclassifications for environmental monitoring in the United States and theEuropean Union. Although these publications are similar in many resp
