WHO第961号技术报告附件7药物生产技术转移指南(中英文1/4)013-09-914:16:7|分类:WHO|字号订阅WorldHealthOrganizationWHOTechnicalReportSeriesNo.961011WHO第961号技术报告附件7药物生产技术转移指南Annex7附件7WHOguidelinesontransferoftechnologyinpharmaceuticalman
•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。
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,WHO举行了健康产品生产和检验良好实践的非正式磋商,其中讨论了清洁验证附录的更新事宜,并在2019年10月的ECSPP会议上进行了该主题的陈述。在这两次会议中,讨论都聚焦于确定安全的清洁...
下载地址:http://www./medicines/areas/quality_safety/quality_assurance/Guidelines_validation_qualification_systems-utilities-equipment_QAS16-673.pdf?ua=1 ·Appendix 7: Non-sterile process validation–update published as Annex 3, WHO Technical Report Series, No. 992, 2015 – will be republished. ...
文件,和— ???qualification and validation. — ???确认和验证 Because each transfer project is unique, the provision of a comprehensive set of guidelines is beyond the scope of this document. 由于每个技术转移项目都是独特的,本文件并不提供一个综合性的整套指南条款。 These guidelines do not provide...
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,...
Appendix4. Analytical procedure validation (6). 附录4 。分析方法验证 (6) 。 Appendix5. Validation of computerized systems (7). 附录5 计算机化系统验证 ) 。 Appendix6. Guidelines on qualification (8). 附录6 确认指南 (8) 。 Appendix7. Non-sterile process validation (9). ...
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...
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,WHO举行了健康产品生产和检验良好实践的非正式磋商,其中讨论了清洁验证附录的更新事宜,并在2019年10月的ECSPP会议上进行了该主题的陈述。在这两次会议中,讨论都聚焦于确定安全的清洁...