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 o
WHO TRS986 附录 2:WHO 药品 GMP 总则, 2014.pdf,Annex 2 WHO good manufacturing practices for pharmaceutical products: main principles1 Introduction 79 General considerations 80 Glossary 81 Quality management in the medicines industry: philosophy and esse
practicalmanuals,handbooksandtrainingmaterialforspecificcategoriesofhealth workers;internationallyapplicableguidelinesandstandards;reviewsandanalysesof healthpolicies,programmesandresearch;andstate-of-the-artconsensusreportsthat offertechnicaladviceandrecommendationsfordecision-makers.Thesebooksare ...
3月29日，WHO发布了第 55 届药物制剂规范专家委员会（ECSPP）技术报告TRS No.1033，其中包含新的《数据完整性指南》，翻译如下，分享给大家！Guideline on data integrity 数据完整性指南 1. Introduction and background 介绍和背景 1.1. In recent years, the number ofobservations made regarding the integrity...
6GXP.Acronymforthegroupofgoodpracticeguidesgoverningthe 1 0 2 ,preclinical,clinical,manufacturing,testing,storage,distributionandpost-market 6 9 9activitiesforregulatedpharmaceuticals,biologicalsandmedicaldevices,suchas . ogoodlaboratorypractices,goodclinicalpractices,goodmanufacturingpractices, N s e igoodpharmaco...
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
3. Good manufacturing practices for pharmaceutical products. In: Quality assurance of pharmaceuticals. A compendium of guidelines and related materials. Volume 2. Good manufacturing practices and inspection. Geneva, World Health Organization, 1999; WHO Expert Committee on Speci?cations for Pharmaceutical ...
requirements or other guideline recommendations. For details on process development, it is recommended that other guidelines, such as those published by The International Council for Harmonisation of Technical Requirements for Pharmaceuticals fo...
3月29日,WHO发布了第 55 届药物制剂规范专家委员会(ECSPP)技术报告TRS No.1033,其中包含新的《数据完整性指南》,翻译如下,分享给大家! Guideline on data integrity 数据完整性指南 1. Introduction and background 介绍和背景 1.1. In recent years, the number ofobservations made regarding the integrity of...
近日,WHO在其技术报告TRS1060中发布了新的《药用辅料GMP》-2025,现将中英文翻译分享给大家: Appendix 2 附录2 List of examples of high - risk excipients and contaminants 高风险辅料和污染物示例列表 1.Introduction 1.引言 The purpose of this appendix is to provide a list of examples of high - risk...