WHO TRS 996-ANNEX 05 数据与记录管理规范指南.PDF,Annex 5 Guidance on good data and record management practices Background During an informal consultation on inspection, good manufacturing practices and risk management guidance in medicines’ manufacturin
WHO TRS981 附录 2-WHO 质量风险管理指南,2013.pdf,Annex 2 WHO guidelines on quality risk management 1. Introduction 62 1.1 Background and scope 62 1.2 Principles of quality risk management 64 2. Glossary 67 3. Quality risk management process 70 3.1 Initia
WHO于2014年TRS986附录2发布了题为“药品GMP:主则”的指南。 TheWHOSupplementaryguidelinesongoodmanufacturingpractice:validationwerepublishedin2006andweresupportedbysevenappendices.The maintext(2)anditsappendixes(3,4,6,7,8,9)wererevisedbetween2006and2019.Appendix3,relatingtocleaningvalidation(5),wasnotupdateda...
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
Annex 4 - WHO guidelines on good manufacturing practices for blood 热度: 107 ©WorldHealthOrganization WHOTechnicalReportSeries,No.937,2006 Annex4 Supplementaryguidelinesongoodmanufacturing practices:validation 1.Introduction 2.Scope 3.Glossary 4.Relationshipbetweenvalidationandqualification ...
WHO_TRS970_annex2(制药用水-对照版) 热度: 61 Annex2 WHOguidelinesonqualityriskmanagement 1.Introduction62 1.1Backgroundandscope62 1.2Principlesofqualityriskmanagement64 2.Glossary67 3.Qualityriskmanagementprocess70 3.1InitiatingaQRMprocess70 3.2PersonnelinvolvedinQRM70 ...
Geneva: World Health Organization; 2016: Annex 5 (WHO Technical Report Series, No. 966; https://www.who.int/medicines/publications/pharmprep/WHO_TRS_996_annex05.pdf, accessed 8 February 2019).8. WHO guidelines on quality risk management. In: WHO Expert Committee on Specifications for ...
内容提示: WHO guidelines on transfer of technology in pharmaceutical manufacturing WHO 技术指南报告 No. 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 ...
961, 2011 世界卫生组织技术报告系列,编号961 ,2011 年 Annex 5 附件5 Supplementary guidelines on good manufacturing practices for heating, ventilation and air-conditioning systems for non-sterile pharmaceutical dosage forms 非无菌制剂的加热通风和空调系统的生产质量管理规范的补充指导原则 目录 1. Introduction...
Available at /trs/WHO_TRS_405.pdf 3. Preventing and controlling anaemia through primary health care: a guide for health administrators and programme managers. Geneva, World Health Organization, 1989. Available at /nutrition/publications/micronutrients/anaemia_iron_deficiency/9241542497.pdf 4. The ...