药品企业国际GMP认证培训资料全集.ppt

Technical Requirements for the Registration Dossier of EDMF/COS/CTD and Filing strategies in EU countries  EDMF/COS/CTD注册文件的技术要求及在欧盟国家的文件编撰策略 Filing strategies CEP ASMF/EDMF procedure ??? 文件编撰策略 CEP ASMF/EDMF程序 ??? ARED E. TIEFENBACHER(GmbH Co)Van-der-Smissen-Str. 122767 HamburgGermanyTel.: +49-40-441809-0Fax.: +49-40-441809-26Mail.: info@ ARED E. TIEFENBACHER(GmbH Co)Van-der-Smissen-Str. 122767 HamburgGermanyTel.: +49-40-441809-0Fax.: +49-40-441809-26Mail.: info@ Preparation and Filing of EDMF/ASMF for COS/CEP applicationies  申请COS/CEP的 EDMF/ASMF文件制作 Certification procedure Application at the EDQM (European Directorate for the Quality of Medicines) How to apply ? Application form Procedere Timetable COS证明程序 在EDQM申请（药品质量欧洲理事会） 怎样申请？ 申请表 程序 时间表 ARED E. TIEFENBACHER(GmbH Co)Van-der-Smissen-Str. 122767 HamburgGermanyTel.: +49-40-441809-0Fax.: +49-40-441809-26Mail.: info@ ARED E. TIEFENBACHER(GmbH Co)Van-der-Smissen-Str. 122767 HamburgGermanyTel.: +49-40-441809-0Fax.: +49-40-441809-26Mail.: info@ Content of the dossier for chemical purity and microbiological quality  文件内容 化学纯度和微生物质量 Schematic description 图解 ALFRED E. TIEFENBACHER(GmbH Co)Van-der-Smissen-Str. 122767 HamburgGermanyTel.: +49-40-441809-0Fax.: +49-40-441809-26Mail.: info@ ALFRED E. TIEFENBACHER(GmbH Co)Van-der-Smissen-Str. 122767 HamburgGermanyTel.: +49-40-441809-0Fax.: +49-40-441809-26Mail.: info@ Application form – Request for New Certificate of Suitability  申请表－－ 新适应性证书的要求 Certification procedure Application at the EDQM (European Directorate for the Quality of Medicines) How to apply ? Application form Procedere Timetable 证明程序 申请EDQM (European Directorate for the Quality of Medicines) 如何申请 ? 申请表 程序 时间表 ALFRED E. TIEFENBACHER(GmbH Co)Van-der-Smissen-Str. 122767 HamburgGermanyTel.: +49-40-441809-0Fax.: +49-40-441809-26Mail.: info@ ALFRED E. TIEFENBACHER(GmbH Co)Van-der-Smissen-Str. 122767 Hamburg