9.5. Programmes and methods (such asprocessing methods in sample analysis (see also Good Chromatography Practices,TRS 1025) should ensure that data meet ALCOA+ principles. Where results or dataare processed using a different method/parameters, then each version of theprocessing method should be recor...
1025; https://www.who.int/docs/default -source/medicines/who -technical -report -series -who -expert -committee -on-specifications -for -pharmaceutical -preparations/trs1025 -annex3.pdf?sfvrsn= caebed51_2 , accessed 29 July 2020). 7. WHO Guidelines on quality risk management. In: WHO Ex...
验证总结报告除了呼应验证计划,声明CDS系统通过验证可以正式运行,还需根据项目最佳实践给出系统GxP数据复核周期以及系统质量回顾周期6.4,4.7。 注:本文中的上标数字均为对应WHO良好色谱规范(WHO TRS 1025 Annex 4 Good Chromatography Practices 2020)章节号 特邀作者 王涛 NNIT 资深验证专家 拥有超过20年生命科学行业经验...
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...
注:本文中的上标数字均为对应WHO良好色谱规范(WHO TRS 1025 Annex 4 Good Chromatography Practices 2020)章节号 特邀作者 王涛/Tao Wang NNIT 资深验证专家 拥有超过20年生命科学行业经验,IT解决方案架构师和验证专家。专注于IT基础架构确认, MES、LIMS系统验证,实验室仪器设备系统验证。为中国本土客户提供验证咨询服务...
WHO_TRS_961-Annex 3 WHO GMP for pharmaceutical products-main principles 星级: 66 页 WHO_TRS_961_annex 7 cold chain 星级: 25 页 WHO_TRS_961Annex9 补充文件10-温度监控装置准确度检查_中英文_完 星级: 36 页 who_trs_908-annex9 星级: 12 页 WHO_TRS_908-Annex9 星级: 12 页 who...
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Annex5 Guidanceongooddataandrecordmanagementpractices Background Duringaninformalconsultationoninspection,goodmanufacturingpractices andriskmanagementguidanceinmedicines’manufacturingheldbythe WorldHealthOrganization(WHO)inGenevainApril2014,aproposalfor newguidanceongooddatamanagementwasdiscussedanditsdevelopment ...
908, 2003Annex 9Guide to good storage practices forpharmaceuticals11.Introduction1252.Glossary1263.Personnel1284.Premises and facilities1285.Storage requirements1316.Returned goods1337.Dispatch and transport1338.Product recall134References134Bibliography134Appendix136Storage and labelling conditions1.IntroductionThis ...
WHO Technical Report Series, No. 970, 2012 Annex 2 附件2Page 1 of 20 Annex 2 附件2 WHO good manufacturing practices: water for pharmaceutical use WHO GMP：制药用水 1. Introduction 介绍 1.1 Scope of the document文件范围 1.2 Background to water requirements and uses 水的要求和使用背景...