ISPE Guide 清洁验证生命周期应用方法和控制(13章).docx

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1、QISPE.GUIDE:Cleaning Validation Lifecycle Applications, Methods, and Controls清洁验证生命周期，应用，方法，和控制Disclaimer:免责声明：The ISPE Guide: Cleaning Validation Lifecycle - Applications, Methods, and Controls provides detailed practical guidance to help pharmaceutical companies meet global regulatory cleaning val

2、idation expectations. This Guide is solely created and owned by ISPE. It is not a regulation, standard or regulatory guideline document. ISPE cannot ensure and does not warrant that a system managed in accordance with this Guide will be acceptable to regulatory authorities. Further, this Guide does

3、not replace the need for hiring professional engineers or technicians.ISPE指南:清洗验证生命周期，应用，方法，和控制提供了详细的实用指导，以帮助制药企业满足全球监 管清洗脸证的要求。本指南完全由ISPE创建和拥有。它不是法规、标准或法规指南文件。ISPE不能保 证，也不能保证，按照本指南管理的系统可以被监管部门接受。此外，本指南并不取代雇用专业工程师 或技术人员的需要。Limitation of Liability责任限制In no event shall ISPE or any of its affiliates, o

4、r the officers, directors, employees, members, or agents of each of them, or the authors, be liable for any damages of any kind, including without limitation any special, incidental, indirect, or consequential damages. whether or not advised of the possibility of such damages, and on any theory of l

5、iability whatsoever, arising out of or in connection with the use of this information.在任何情况下，ISPE或其任何关联公司，或其管理人员、董事、员工、成员或代理人，或作者，均不应 对任何类型的任何损害负责，包括但不限于任何特殊的、偶然的、间接的或间接的损害。是否告知发生 此种损害的可能性。以及因使用本信息而产生的或与之有关的任何责任理论。 Copyright ISPE 2020. All rights reserved.版权所有ISPE 2020保留所有权利。All rights reserved. No

6、part of this document may be reproduced or copied in any form or by any means -graphic, electronic, or mechanical, including photocopying, taping, or information storage and retrieval systems -without written permission of ISPE.保留所有权利。未经ISPE书面许可，不得以任何形式或任何方式复制或复制本文件的任何部分，包括图 像、电子或机械，包括复印、录音或信息存储和检索系

7、统。All trademarks used are acknowledged. ISBN 978-1-9469,6431-1所有使用的商标均得到承认OISBN 978-1-9469, 6431 -1Preface前言Regulatory agencies expect the development and validation of a compliant cleaning program. This critical activity ensures that the risks of contamination, product carryover, and cross-contamin

8、ation are controlled, minimized, and monitored to safeguard patient safety and product quality.监管机构期望开发和险证一个合规的清洗程序。这一关键活动确保污染、产品转移和交叉污染的风险得 到控制、最小化和监控，以保障患者安全和产品质量。This ISPE Guide: Cleaning Validation Lifecycle - Applications; Methods, and Controls describes the application of the process lifecycle

9、 model to cleaning. This will aid organizations in developing and adopting scientifically sound approaches, resulting in a robust cleaning validation program.本ISPE指南:清洗验证生命周期，应用，方法，和控制描述了过程生命周期模型在清洗中的应用。这将帮 助组织发展和采用科学合理的方法，从而产生一个完善的清洁验证程序。An integral part of an effective cleaning program is using ri

10、sk-based approaches in the design and management of the validation process; accordingly, this ISPE Guide is aligned with the principles described in the ISPE Baselined Guide: Volume 7-Risk-Based Manufacture of Pharmaceutical Products Risk-MaPP (Second Edition).有效的清洗程序的一个组成部分是在验证过程的设计和管理中使用基于风险的方法；因此

11、，本ISPE指南 与ISPEBaSeline指南:基于风险的第7卷药品制造Risk-MaPP(第二版)中所述的原则保持一致。This ISPE Guide: Cleaning Validation Lifecycle -Applications, Methods, and Controls promotes the use of health-based exposure limits (HBEL) and offers guidance and examples for developing and/or transitioning to the determination of clean

12、ing specifications using HBEL.本ISPE指南:清洗验证生命周期应用、方法走赛制促进基于健康的暴露极限(HBEL)的使用，并为使用 HBEL制定和/或过渡到确定清洗规范提供指导和示例。Created by a team of industry experts with global experience, this ISPE Guide is intended as a reference for the cleaning lifecycle model as well as a practical guide for applying the theory and

13、 concepts to help create compliant and effective cleaning programs.该ISPE指南由具有全球经验的行业专家团队创建，旨在作为清洁生命周期模型的参考，以及应用理论和 概念帮助创建符合要求和有效的清洁方案的实用指南。Acknowledgements鸣谢The Guide was produced by a Task Team led by Jose Caraballo (Bayer U.S., USA) and Joseph Payne (Tergyus Pharma (formerly with Alcami Corp.), US

14、A).该指南是由 Jose CarabaIIo(美国拜耳公司)和 JoSePh Payne (美国 Tergus Pharma 公司(原 AIcamiCorp.) 领导的一个任务小组编写的。Core Team核心团队The following individuals took lead roles in the preparation, writing, and review of this Guide: 以下人员在本指南的准备、撰写和审查中发挥了主导作用：Jose CaraballoPfizer Ltd.USALiz DallisonForsyth Pharmaceutical Consul

15、tingUnitedRich ForsythBluehatch Consultancy Ltd.KingdomTrefor JonesSTERIS CorpUSABeth Kroeger-FahnestockI IQElectrol Specialties Co.Sam LebowitzOakes Group GlobalTurkey/USACatherine OakesNovo NordiskUSAFred OhsiekQTergus Pharma (formerly with Alcami Corp.)Joseph Paynee I , c ,USA/AsiaVTI Life Scienc

16、es, Inc.David W. Vincent, MPH, PhDUSABayer U.S.United KingdomOther Contributors其他贡献者The Core Team wish to thank the following individuals for their valuable contribution to the document. 核心小组感谢下列人士对该文件所作的宝贵贡献。Janet FreerPfizer Ltd. (retired)JapanHiroaki MatsumotoAsahi Kasei Finechem Co.USA.Rizwan Sharnez, PhDLtd. Cleaning Val