A certificate of origin for each product, complying with US guidelines, can be downloaded from the Ph. Eur. reference standards database. 每种产品的原产地证明(符合美国指南),可从欧洲药典标准物质数据库下载。 Safety Data Sheets (SDS), where applicable, can be accessed via the Ph. Eur. referenc...
(2)ISO 9001 Certificate,可下载 ISO 9001证书(3)ISO 17025 Certificate ,可下载ISO 17025证书(4)Safety Management System安全管理体系;第三部分“Contact us与EDQM沟通途径”和第四部分“Career如何加入EDQM”等。模块④:Medicines医药 在该模块主要包括:European Pharmacopoeia(Ph. Eur.)欧洲药典、Biological ...
第二部分:“Management Systems 管理体系”,包括(1)Quality质量,EDQM获得了法国认证机构AFAQ/Afnor认证的ISO 9001认证。(2)ISO 9001 Certificate,可下载 ISO 9001证书(3)ISO 17025 Certificate ,可下载ISO 17025证书(4)Safety Management System安全管理体系; 第三部分“Contact us与EDQM沟通途径”和第四部分“Career...
EDQM认证程序及其在中国的现场检查要求.pdf,Understanding Updated EDQM Certification Procedure and First Hand Experience With Regards to On-site API Inspections in China CPhI China Conference 27 June 2012 Dr Florence BENOIT-GUYOD, EDQM, Council of Europe Ov
The CEP certifies that by applying the relevant monographs of the Ph. Eur., if necessary with an annex attached to the certificate describing additional tests and their limits, it is possible to check whether or not the quality of the substance is suitable for use in medicinal products. In ...
APIInspections:theEDQMexperience29March2010FlorenceBenoit-Guyod,EDQMInspectorCertificationofsubstancesDivision,EDQMDrFlorenceBenoit-Guy..
第二部分:“Management Systems 管理体系”,包括(1)Quality质量,EDQM获得了法国认证机构AFAQ/Afnor认证的ISO 9001认证。(2)ISO 9001 Certificate,可下载 ISO 9001证书(3)ISO 17025 Certificate ,可下载ISO 17025证书(4)Safety Management System安全管理体系; ...
第二部分:“Management Systems 管理体系”,包括(1)Quality质量,EDQM获得了法国认证机构AFAQ/Afnor认证的ISO 9001认证。(2)ISO 9001 Certificate,可下载 ISO 9001证书(3)ISO 17025 Certificate ,可下载ISO 17025证书(4)Safety Management System安全管理体系; ...
EDQM认证程序及其在中国的现场检查要求.pdf,Understanding Updated EDQM Certification Procedure and First Hand Experience With Regards to On-site API Inspections in China CPhI China Conference 27 June 2012 Dr Florence BENOIT-GUYOD, EDQM, Council of Europe Ov
When required by the prescribed test and/or assay of the corresponding Ph. Eur. text, the content of a CRS is given in the leaflet available in the Ph. Eur. reference standards database. 当欧洲药典中规定的检测项目和/或含量测定需要某标准物质的标示含量时,此标准物质的标示含量可以在欧洲药典标...