内容提示: WHO TRS 目录 WHO TRS 1003 Fifty-first report 报告 51 Annex 1 附录 1 WHO guidelines for selecting marker substances of herbal origin for quality control of herbal medicines 针对药草药品质量控制的草药源头标记物质选择的 WHO 指南 Annex 2 附录 2 The International Pharmacopoeia: revised ...
2.4. Where possible, this guideline hasbeen harmonised with other published documents on data integrity. Thisguideline should also be read with other WHO good practices guidelines andpublications including, but not limited to, those listed in the referencessection of this document. 本指南已尽可能与...
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
batch release testing, in-process controls, special controls, inspection for customs clearance, deterioration and adulteration, or for obtaining a retention sample are described in the WHO guidelines for sampling of pharmaceutical products
WHO_TRS_929-Annex4[1] 热度: Annex 4 WHO guidelines for sampling of pharmaceutical products and 热度: Annex 4 - WHO guidelines on good manufacturing practices for blood 热度: 107 ©WorldHealthOrganization WHOTechnicalReportSeries,No.937,2006 ...
WHO-清洁验证新指南--WHO-TRS-1019-53之间的时间间隔的生产和清洁过程的开始间隔可能验证挑战研究本身的一部分设备的最大时期可能离开脏在清洗之前以及之后建立的时间应该消逝的清洁和使用前 WHO 在上个月发布新指南 WHO TRS 1019-53,英文全文303页, 本文节选其中 清洁验证部分,进行了翻译,供参考。 Appendix3 ...
WHO_TRS_961-Annex 3 WHO GMP for pharmaceutical products-main principles童静20121221 热度: GUIDELINES ON ANNEX I TO REGULATION (EC) NO 1223/2009 ON ... - ICADA 热度: Annex 1 Guidelines on clinical evaluation of vaccines :附件1准则对疫苗的临床评价 ...
WHO在上个月发布新指南WHO TRS 1019-53,英文全文303页, 本文节选其中清洁验证部分,进行了翻译,供参考。 Appendix3 Cleaningvalidation 清洁验证 Thetext of this appendix was previously published as: 本附录的文本以前以下列形式发表: ■■ Appendix 3: Cleaning validation. In: WHO Expert Committee on Specifica...
WHO“BiowaiverList”:proposaltowaiveinvivobioequivalencerequirementsfor WHOModelListofEssentialMedicinesimmediate-release,solidoraldosageforms197 Annex9 GuidelinesontheimplementationoftheWHOCertificationSchemeonthequality ofpharmaceuticalproductsmovingininternationalcommerce205 ...
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