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 good data and record managementpractices (WHOTechnical Re...
制药用水系统验证(validation of water systems for pharmaceutical use); 分析程序验证(validation of analytical procedures); 计算机系统验证(validation of computerized systems); 确认指南(guidelines on qualification); 非无菌工艺的验证(validation of non-sterile processes)。 清洁验证附录的更新事宜 2019年7月,WH...
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, ...
the WHO Good manufacturing practices: guidelines on validation ( 2 ) were updated and republished. Some of the seven appendices were also individually updated between 2013 and 2019:
•Appendix 2: Validation of water systems for pharmaceutical use- will be replaced by cross-reference to WHO Guidelines on water for pharmaceutical use for consideration in qualification of water purification systems •附件2:制药用水系统的验证——将参考WHO制药用水指南中纯化水系统的确认进行修订。
近⽇，WHO发布了新的清洁验证指南——《不同⽅法——包括HBEL——建⽴清洁验证的残留 限度以确定共⽤设施⽣产污染风险的考量》，该指南解读如下：传统的⽅法是进⾏清洁验证并基于GMP⽂件中建议的接受标准来判断清洁程序的适⽤性。这种 做法可能不再是可以接受的和合理的，因为没有考虑到HBEL。鉴于...
8. WHO Guidelines on validation. In: WHO Expert Committee on Specifications for Pharmaceutical Preparations: fifty -third report. Geneva: World Health Organization; 2019: A nnex 3 (WHO Technical Report Series, No. 1019; https://www.who.int/medicines/areas/quality_safety/quality_assurance/WHO_...
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...
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,...
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...