WHO《设备 设施 系统确认指南》-2018（中英文版）
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WHO 《验证指南 附录 6 确认指南》 2018 年二月 1/10
VALIDATION
验证
APPENDIX 6
附录 6
GUIDELINES ON QUALIFICATION
确认指南
(February 2018)
2018 年二月
DRAFT FOR COMMENTS
征求意见稿
Working document QAS/16.673/Rev.1
February 2018
Draft document for comment
WHO 《验证指南 附录 6 确认指南》 2018 年二月 2/10
1. PRINCIPLE
原则
1.1 In principle, premises, systems, utilities and equipment should be appropriately designed,
located, installed, operated, cleaned, maintained and qualified to suit their intended purpose.
原则上，厂房、系统、设施和设备应适当设计、安置、安装、运行、清洁、维护和确认，使其
符合既定用途。
1.2 Quality management systems should be in place to ensure that these remain in a
qualified state throughout their life cycle.
应有质量管理体系以确保其在生命周期内保持在一个已确认状态。
1.3 Products should be manufactured on qualified equipment.
产品应在已确认的设备上生产。
2. SCOPE
范围
2.1 These guidelines describe the general approach to qualification for, e.g. premises,
systems, utilities and equipment.
本指南描述了厂房、系统个、设施和设备确认的一般方法。
2.2 The principles in these guidelines may also be applied to the qualification of instruments,
analytical instruments and testing devices; where appropriate.
适当时，本指南中的原则也适用于仪器和分析仪器和检验设备的确认。
2.3 These may include and are not limited to: certain rooms; water purification systems;
cleaning systems; heating, ventilation and air conditioning systems; compressed air systems;
gas systems; steam systems; as well as production equipment and analytical instruments.
包括但不限于：某一房间、纯化水系统、清洁系统、HVAC 系统、压缩空气系统、气体系统、
蒸汽系统，以及生产设备和分析仪器。
2.4 Separate guidelines in this series address other principles in validation such as process
validation and cleaning validation (see references at the end of this document).
尚有其他描述诸如工艺验证和清洁验证原则的专用指南（参见本文件末尾的参考文献）。
3. GLOSSARY
术语
design qualification. Documented evidence that, e.g. the premises, supporting systems,
utilities and equipment have been designed for their intended purposes and in accordance
with the requirements of good manufacturing practices.
WHO 《验证指南 附录 6 确认指南》 2018 年二月 3/10
设计确认：文件证明，如厂房、辅助系统、设施和设备已按照其既定目的设计并符合 GMP 要
求。
factory acceptance test. A test conducted, usually at the vendor’s premises, to verify that
the system, equipment or utility, as assembled or partially assembled, meets expected
specifications. (new)
工厂验收测试：一个测试，通常在供应商处进行，以确认装配或部分装配的系统、设备或设施
符合其预期标准（新）。
installation qualification. The performance of tests to ensure that the installations (such as
machines, measuring devices, utilities and manufacturing areas) used in a manufacturing
process are appropriately selected and correctly installed and operate in accordance with
established specifications.
安装确认：执行测试以确保生产过程中使用的安装（如设备、检测仪器、设施和生产区域）适
当选择并正确安装，并按照既定标准操作。
operational qualification. Documented verification that the system or subsystem
performs as intended over all anticipated operating ranges.
运行确认：文件确认系统或子系统在所有预定操作范围都符合预期。
performance qualification. Documented verification that the equipment or system operates
consistently and gives reproducibility within defined specifications and parameters for
prolonged periods. (In the context of systems, the term “process validation” may also be
used.)
性能确认：文件证实设备或系统运行可以保持长时间一贯可重现地符合规定的标准和参数。（对
于系统，也可以使用“工艺验证”）
site acceptance test. A test conducted at the site of use to verify that the system,
equipment or utility, as assembled or partially assembled meets expected specifications.
(new)
现场验收测试：在使用场地进行的测试以确认装配或部分装配的系统、设备或设施符合预期标
准。（新）
system. A regulated pattern of interacting activities and techniques that are united to form
an organized whole.
系统：交互活动和技术联合形成一个有组织的整体。
user requirement specifications. An authorized document that defines the requirements
for use of the system, equipment or utility in its intended production environment. (amended)
用户需求规范：一个经批准的文件，定义了系统、设备或设施在其既定生产环境的使用要求。
utility. A system consisting of one or more components to form a structure designed to
collectively operate, function or perform and provide a service such as electricity, water,
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WHO《验证指南附录6确认指南》2018年二月1/10VALIDATION验证APPENDIX6附录6GUIDELINESONQUALIFICATION确认指南(February2018)2018年二月DRAFTFORCOMMENTS征求意见稿WorkingdocumentQAS/16.673/Rev.1February2018DraftdocumentforcommentWHO《验证指南附录6确认指南》2018年二月2/101.PRINCIPLE原则1.1Inprinciple,premises,systems,utilitiesandequipmentshouldbeappropriate...
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时间：2026-06-30
