1.1. In view of an old publication date,and the recent need for new guidelines arising from inspections carried out forCOVID-19 therapeutics, the World Health Organization (WHO) PrequalificationTeam-Inspection Services (PQT INS) raisedthe urgency for a revision of the WHO Good manufacturing practi...
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,...
• qualification and validation. •确认和验证。 3. Glossary 术语 The definitions given below apply to the terms used in these guidelines. They have been aligned as far as possible with the terminology in related WHO guidelines and Good Practices and included in the WHO Qual...
摘要: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)》 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 ...
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
2.5. There are further risks associatedwith the production, validation, control, shipping, storage and use ofinvestigational products. 在临床试验药品的生产、验证、检验、运输、存贮和使用中还存在其它风险。 2.6. To minimize risks and ...
2.3Thegeneraltextinthemainpartoftheseguidelinesmaybeapplicabletovalidationandqualificationofpremises,equipment,utilities,systems,processesandprocedures. 这些指南的主体部分的一般内容可能适用于设施、设备、公用设施和系统、工艺和程序的验证和确认。 3.GLOSSARY 术语 Thedefinitionsgivenbelowapplytothetermsusedintheseguidelin...
Performance qualification is described as applicable to equipment and systems. In the context of systems, the term “process validation” could also be used. There is also a own definition for the term “validation“ (“Action of proving and documenting that any process, procedure or method ...
1.1.Productionandcontrolprocedures,validationandother relatedactivitiesmaybetransferredfromonesitetoanother sitepriortoobtainingamarketingauthorization.Insome cases,thistransfertakesplaceaftertheapprovalof,for example,aproduct,byaregulatoryauthority.Thistransfer ...
Other WHO guidelines address specificrequirements and recommendations including but not limited to stabilitytesting, analytical method validation, cleaning validation and the transfer oftechnology (TOT). (See the Referencesand Further Reading sections). WHO题为《人用临床试验用药良好生产规范》的文件(1)专门...