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Qualification of temperature-controlled storage areas Technical supplement to WHO Technical Report Series, No. 961, 2011 Annex 9: Model guidance for the storage and transport of time and temperature–sensitive pharmaceutical products August 2014 WHO第961号技术报告 附录9：时间和温度敏感的药品的贮运指南技术补充之 温控存贮区的确认 (小编按：有兴趣的会员朋友们可来信索取完整中英文PDF) World Health Organization 2014 WHO Press, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland (tel.: +41 22 791 3264; fax: +41 22 791 4857; e-mail: bookorders@who.int). Requests for permission to reproduce or translate WHO publications – whether for sale or for noncommercial distribution – should be addressed to WHO Press, at the above address (fax: +41 22 791 4806; email: permissions@who.int). The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate border lines for which there may not yet be full agreement. The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by the World Health Organization in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters. All reasonable precautions have been taken by the World Health Organization to verify the information contained in this publication. However, the published material is being distributed without warranty of any kind, either expressed or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall the World
Health Organization be liable for damages arising from its use. The named authors alone are responsible for the views expressed in this publication. Acknowledgments 致谢(略) Abbreviations 缩写
Glossary 术语（略） 1. Introduction 概述 This technical supplement has been written to amplify the recommendations given in clause 4.7 of WHO Technical Report Series No. 961, 2011, Annex 9: Model guidance for the storage and transport of time- and temperature-sensitive pharmaceutical products[4]. It covers the three stages of qualification needed to release a temperature-controlled storage area for routine use: installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ). Related topics are covered in the following Technical Supplements: 本技术补充文件是为了细化WHO第961号技术报告附录9时间和温度敏感的药品的贮运指南技术补充第4.7条里给出的建议。它包括了将温控存贮区放行使用的三段确认：安装确认（IQ）、运行确认（OQ）和性能确认（PQ）。相关主题包括在以下技术补充文件中：
What is 'qualification'? 什么是'确认'？ In the context of this series of Technical Supplements, qualification is an inspection and testing process used to establish that a piece of equipment or a physical installation is fit for purpose in the operational context within which it will be used. There are typically three stages in the process. Each stage must be fully completed before the next one begins. 在本系统技术补充文件中，“确认”是指对一件设备或物理固件进行检查和测试，确认其适合在将要使用的操作环境和条件下使用。在此过程中一般有三个阶段。每个阶段必须全部完成后才能开始下一阶段。 Stage 1 (for equipment): Establish by laboratory testing under tightly controlled conditions that a specific item of equipment performs in accordance with the user requirements specification (URS). This is design qualification. Whilst design qualification demonstrates compliance with the URS and associated test protocols; it does not prove that the equipment will be suitable in a specific operating environment because the URS and the test procedures are unlikely to reflect the full range of operating conditions. 第1阶段（确认设备）：在严格控制的实验室条件下，证明特定的设备性能符合用户需求标准（URS）。这就是“设计确认”。设计确认证明的是符合URS及相关的测试方案，它不证明设备是否适用于特定的操作环境，因为URS和测试程序不可能反映操作条件的整个范围。 Stage 1 (for installations): Establish by documented inspection and testing that an installation[5] that has been assembled in a specific location is fully in accordance with the user requirements specification and installation drawings. This is installation qualification. 第1阶段（安装）：在指定的位置进行装配，检查和测试该安装符合用户需求标准和安装图纸并进行书面记录。这就是“安装确认”。 Stage 2: Establish by further documented testing under controlled conditions that this equipment or installation is likely to perform as intended in the operating environment in which it will be used. This is operational qualification. 第2阶段：在受控条件下进一步测试并记录该设备或安装可以在操作环境中按其既定目的运行。这就是“运行确认”。 Stage 3: Carry out a final stage of documented testing to establish with a high degree of assurance that the equipment or installation, together with all associated systems, does indeed perform as intended under routine operating conditions. This is performance qualification. 第3阶段：最后进行高要求的测试，保证设备或安装以及所有辅助系统在常规操作环境中按预期运行并达到预期效果，并记录。这就是“性能确认”。 1.1 Requirements 要求 Every new temperature-controlled store must be qualified before it is released for the routine storage of TTSPPs. As a minimum, the qualification procedure should: 每个新的温控存贮区必须在放行用于TTSPP的常规存贮前进行确认。确认程序最少应：
Further qualification exercises should be conducted whenever significant modifications are made to the installation, or to the way in which it is used. The qualification process must be fully documented in order to demonstrate compliance to management, clients and regulatory authorities. 如果对安装或其用途做了重大更改，则需要做进一步的确认。确认过程必须全部记录，以证明其符合管理、客户和法规当局的要求。 Qualification activities should be planned and documented. The plan should set out the sequence of testing activities to be carried out. It should also describe the method(s) for ensuring traceability between the individual test activities and the specific design features being tested. 应对确认活动进行计划和记录。计划应设定测试活动的实施顺序，还要描述测试方法以保证单个测试活动与受测试的特定设计属性之间的可追溯性。 1.2 Objectives 目的 This Technical Supplement applies to fixed storage locations used for TTSPP logistic operations. The objective is to provide guidance on how to carry out the three types of qualification needed to meet the requirements of Good Storage Practice in temperature-controlled areas. These are Installation Qualification (IQ); Operational Qualification (OQ), and Performance Qualification (PQ). 本技术补充文件适用于TTSPP物料操作所用固定的存贮位置。其目的是提供如何实施三类确认以符合温控区优良存贮规范的指南，即安装确认（IQ）、运行确认（OQ）和性能确认（PQ）. 1.3 Target readership 目标读者 This document is relevant to wholesalers, warehouse operators, distributors, dispatchers and 3PLs who store TTSPPs. The specific target audience within these organizations includes those who have direct responsibility for quality management, for example, Quality Assurance (QA) Managers and Operations Managers. 本文与存贮TTSPP的批发商、仓库运营者、分销商、发货人和3PL有关。本文件目标读者是这些组织内的人员，包括质量管理的直接责任人，例如质量保证经理和营运经理。 2. Guidance 指南 The purpose of qualification in the pharmaceutical and medical sector is to ensure that equipment or ancillary systems are properly installed, work correctly, and produce the specified performance outcomes under routine operating conditions. 在药品和医疗领域进行确认的目的是保证设备或辅助系统进行了适当的安装，能在常规的运转条件下产生指定的性能结果。 2.1 Associated materials and equipment 辅助物料和设备 A qualification operation requires a sufficient number of electronic data logging monitors (EDLMs) to ensure that qualification activities can be carried out correctly. In addition, suitable computer equipment and software is needed to store and analyse the data. The chosen EDLMs should have the following characteristics: 一个确认操作需要有充分数量的电子数据记录监测仪（EDLM）来保证确认活动可以正确实施。另外，还需要有适当的计算机设备和软件来存贮和分析数据。所选择的EDLM应具有如下特性：
2.2 Introduction to qualification 确认概述 Qualification is part of validation, but the individual qualification steps do not in themselves constitute process validation. Validation is the entire process by which a product is obtained from a manufacturer or distributor and is examined and tested before it is formally approved for routine use. 确认是验证的一部分，但单个确认步骤并不构成验证过程。验证是从生产商或分销商处获得产品，进行检查和测试，然后正式批准用于日常使用。 A qualification exercise generally consists of four sequential phases: Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). 一个确认操作通常包括四个连续的阶段：安装确认（IQ）、运行确认（OQ）和性能确认。
2.2.1 Qualification applied to temperature-controlled storage 适用于温控存贮的确认 Qualification is commonly used to validate pharmaceutical manufacturing processes but it can also be applied to the pharmaceutical supply chain in general, and to temperature-controlled storage processes and equipment in particular. 确认通常用于验证药品生产过程，但它也可以用于药品供应链，特别是用于温控存贮过程和设备。 In this later context, temperature-controlled storage covers any area where TTSPPs have to be stored within a controlled temperature range (e.g.: 2.0°C to 8.0°C, 15.0°C to 25.0°C). 在后续的内容中，温控存贮包括TTSPP要存贮在受控温度范围内的所有区域（例如2.0°C to 8.0°C, 15.0°C to 25.0°C）。 This includes: 这包括
All temperature-controlled equipment and systems used to handle, store and distribute TTSPPs should be qualified. 所有用于处理、存贮和分发TTSPP的温控设备和系统均应进行确认。 An integrated IQ, OQ and PQ procedure is commonly used to qualify temperature-controlled storage areas. Ideally the IQ, OQ and PQ procedures should be applied in a progressive and coordinated way, from the installation up to the final performance verification. However this may be more difficult if the storage areas and equipment are already in use. 通常采用整合的IQ、OQ和PQ程序来对温控存贮区进行确认。理想状态是IQ、OQ和PQ过程相互衔接和协作，从安装一直到最终性能确认。但是，如果存贮区域和设备已经投入使用了，则可能比较难做到。 2.2.2 Installation qualification 安装确认 IQ过程应首先完成。其目的是保证清楚识别出存贮区域和所有辅助设备和系统，并保证其安装正确。该步骤必须在所有进一步功能性和操作性测试前完成。 Specifically, an IQ process should: 一般来说，一个IQ过程应
2.2.3 Operational and performance qualification 运行确认和性能确认 Once the IQ stage has been completed, the OQ and PQ can generally be carried out together as a single sequence of inspections and tests. These inspections and tests should be chosen to suit the specific characteristics, performance needs and operational conditions of the storage area being qualified. 一旦IQ阶段完成，则通常就可以开始OQ和PQ。它们可以按检查和测试顺序一起实施。这些检查和测试的选择应适合被确认存贮区域指定的属性、性能要求以及运行条件。 Operational qualification is carried out with the storage area or equipment empty. It typically involves the following assessments: 运行确认是对空的存贮区域或设备实施的。一般它会涉及以下评估：
Note: In this context ‘empty storage space or equipment’ means that no products are being stored and normal operations have yet to begin. 注：在此“空载存贮区域或设备”表示没有产品存贮在其中，常规操作还没有开始。 Performance qualification is carried out with the storage area or equipment fully operational, loaded and allowed to reach stabilized conditions. The following tests and checks should be carried out: 运行确认是要在存贮区域或设备全面运转，装载产品并使其达到稳定条件后才开始实施的。要实施以下测试和检测
Note: In this context ‘loaded storage space or equipment’ means that the store or equipment has begun to receive products and normal operations have commenced. |
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