manufacturingpractices(GMP)forpharmaceuticalproducts:mainprinciples, publishedasAnnex3intheWHOTechnicalReportSeries,No.961,2011, would needupdating(/medicines/areas/quality_safety/quality_ assurance/production/en/index.html−Qualityassuranceofpharmaceuticals: acompendiumofguidelinesandrelatedmaterials). TheWHOExpert...
附录2 WHO药品GMP指南_中英文_.pdf,Annex 2 WHO good manufacturing practices for pharmaceutical products: main principles 附录2 WHO药品GMP:主要原则 Introduction引言 General considerations总则 Glossary术语 Quality management in the medicines industry: philo
欧盟《GMP》附录1无菌药品生产-1-EUROPEANCOMMISSION 欧盟委员会 ENTERPRISEANDINDUSTRYDIRECTORATE-GENERAL 企业和工业常务委员会 Consumergoods食品Pharmaceuticals药品Brussels14February008布鲁塞尔008..14EudraLexTheRulesGoverningMedicinalProductsintheEuropean
Promising Pharmaceuticals 102 In the 1980s, US FDA began publishing series of guidance documents that have had a major effect on our interpretation of current GMP (cGMP). A “Guide to Inspection of Computerized Systems in Drug Processing” was published in 1983 and “Guideline on ...
欧盟GMP 附录 15:确认与验证 (修订版英文 + 中文 ) EUROPEAN COMMISSION ENTERPRISE DIRECTORATE-GENERAL Single market, regulatory environment, industries under vertical legislation Pharmaceuticals and cosmetics Brussels,30 March 2015 EudraLex 欧盟药品管理法 Volume 4 EU Guidelines for Good Manufacturing Practice...
Analysis and Critical Control Point (HACCP) methodology to pharmaceuticals. IEC 61882 - Hazard Operability Analysis (HAZOP). ISO 14971:2000 - Application of Risk Management to Medical Devices. ISO 7870:1993 - Control Charts. ISO 7871:1997 - Cumulative Sum Charts. ...
内容提示: Working document QAS/20.842 May 2020 DRAFT WORKING DOCUMENT FOR COMMENTS : Good manufacturing practices: water for pharmaceutical use Please send your comments to Dr Sabine Kopp, Team Lead, Norms and Standards for Pharmaceuticals, Technical Standards and Specifications (kopps@who.int), with...
Summary This chapter contains sections titled: FDA Regulations: Real and Imagined 21 CFR 210 and 211: Current Good Manufacturing Practice for Finished Pharmaceuticals Guidance for Industry: Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations Guidance for Industry: PAT—...
欧盟GMP附录1计算机系统(中英文对照).pdf,. EUROPEAN COMMISSION 欧盟委员会 HEALTH AND CONSUMERS DIRECTORATE-GENERAL 卫生与消费者协会 Public Health and Risk Assessment 公共卫生与风险评估 Pharmaceuticals 药品 Brussels, SANCO/C8/AM/sl/ares(2010)1064599 EudraLe
Pharmaceuticals:regulatoryframeworkandmarketauthorisations Brussels, F2/BLD(2003) Revision1 VOLUME4 Goodmanufacturingpractices ANNEX13 Manufactureofinvestigationalmedicinal products JULY2003 ANNEX13REVISION1 PRINCIPLE Investigationalmedicinalproductsshouldbeproducedinaccordancewiththeprinciplesand thedetailedguidelinesofGoodMa...