It provides information on different specifications for WPU; good practices for the management of the quality of water systems; water treatment (production) systems; water storage and distribution systems; commissioning, qualification and validation; sampling and testing; and the routine monitoring of wat...
961, 2011, annex 7 WHO 药品生产技术转移的指导原则 1 of 32 © World Health Organization 世界卫生组织 WHO Technical Report Series, No. 961, 2011 世界卫生组织技术报告系列,编号 961, 2011 年 Annex 7 附录 7 WHO guidelines on transfer of technology in pharmaceutical manufacturing WHO 药品生产技术...
Supplementaryguidelinesongoodmanufacturingpractices:validation(1)was identifiedbythePrequalificationofMedicinesProgrammeandafirstdraft documentwascirculatedforcommentinearly2013.Thefocus,atthattime,was revisionoftheappendixonNon-sterileprocessvalidation(Appendix7)(2),which ...
1.1 This appendixpresents some information on the characteristics that should be consideredduring validation of analytical methods.Approaches other than those specified in this appendixmay be followed and may be acceptable.Manufacturers should choose the...
1、Annex 4 附件 4Supplementary guidelines on good manufacturing practices: validation 药品生产质量管理规范补充指南:验证1 Introduction 简介2 Scope 范围 3 Glossary 术语4 Relationship between validation and qualication 验证和确认之间的联系5. Validation 5.1. Approaches to validation 验证方法5.2. Scope of ...
1.2Theseguidelinescoverthegeneralprinciplesofvalidationandqualification.Inadditiontothemainpart,appendicesonvalidationandqualification(e.g.cleaning,computerandcomputerizedsystems,equipment,utilitiesandsystems,andanalyticalmethods)areincluded. 这个指南包括验证和确认的一般原则。除了主体部分外,还包括确认和验证附件(如清洁、...
近日,WHO发布了《设备/设施/系统确认指南》,本次将该指南原标题《Validation on qualification of systems, utilities and equipment(系统、设施和设备确认指南)》更名为《Guidelines on qualification(关于确认的指南)》: 适用于包括但不限于:洁净室、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...
GUIDELINES ON QUALIFICATION - APPENDIX 6 VALIDATION 确认指南-附录6 验证 (September 2018) DRAFT FOR COMMENTS 征求意见稿 APPENDIX 6 GUIDELINES ON QUALIFICATION 附录6-确认指南 1. Principle 原则 2. Scope 范围 3. Glossary 术语 4. General 概述 5. User requirement specifications 用户需求说明 6. Design...
Therearemanyfactorsaffectingthedifferenttypesofvalidationanditis,therefore,notintendedtodefineandaddressallaspectsrelatedtooneparticulartypeofvalidationhere.有很多因素会对不同类型的验证产生影响,因此,这里不会对某个特定类型的验证相关的所有方面进行定义和说明。Thegeneraltextinthemainpartoftheseguidelinesmaybeapplicable...
5.12 The scope and extent of validation should be based on knowledge and experience, and the outcome of quality risk management principles as described in the World Health Organization (WHO) guidelines on quality risk management. Where necessary worst-case situations or specific challenge tests should...