WHO《设备 设施 系统确认指南》-2018（中英文版）.pdfVIP

Working document QAS/16.673/Rev.1 February 2018 Draft document for comment 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 翻译：流浪的沙子 校对：Owen GMP 办公室组织翻译 GMP 办公室 • 专业的GMP 合规性研究组织 • 国内外（FDA、EMA、MHRA、CFDA、WHO、PIC/S 等）GMP 法规解读； • 国内外制药行业GMP 监管动态； • GMP 技术指南（ISPE、PDA、ISO、ASTM 等）分享 官方微信公众号： WHO 《验证指南附录6 确认指南》 2018 年二月 1/10 GMP 办公室翻译组 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; s