1. Supplementaryguidelines on good manufacturing practices: validation (WHO TechnicalReport Series, No. 937, 2006, Annex 4). 2. Generalguidelines for the establishment, maintenance and distribution of chemical reference substances WHO Guidelines on g...
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...
WHO TRS1019 附录 3-GMP 验证指南,附录 5,计算机化系统的验证,2019.pdf,Annex 3 Good manufacturing practices:guidelines onvalidation Background The need for revision of the published World Health Organization (WHO) Supplementary guidelines on good manufact
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,...
Annex 4 附件 4 Supplementary 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 quali?cation 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 ...
(Note. This section highlights some specific aspects relating to the use of computerized systems. It is not intended to repeat the information presented in the other WHO Guidelines here, such as the WHO Guideline on Computerized systems, WHO ...
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、...
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...
The WHO Supplementary guidelines on good manufacturing practice: validation were published in 2006 and were supported by seven appendices. The main text and its appendixes were revised between 2006 and 2019. Appendix 3, relating to cleaning validation , was not updated at that time. Its revision,...
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 ...