A certificate of suitability to the monographs of the European Pharmacopoeia (CEP) issued by the EDQM is considered to replace the relevant sections in the application for marketing authorization demonstrating the quality of substances for pharmaceutical use. The inclusion of a CEP in an MAA ...
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...
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...
if any expected changes for CEP revision have been submitted, an inspection attestation is delivered, stating the compliance with the CEP and with the GMP • A GMP Certificate may be issued by the participating Inspectorate (EMEA/INS/GMP/871/04) ...
and if any expected changes for CEP revision have been submitted, an inspection attestation is delivered, stating the compliance with the CEP and with the GMP • A GMP Certificate should be issued by the participating Inspectorate (EMA/INS/GMP/459921/2010 Rev 13 Compilation of Community ...
第一部分:“Certification适用性认证”,药品质量管理局(EDQM)提供欧洲药典适用性认证(CEP认证),CEP认证不仅被所有欧盟成员国所承认,而且被很多承认欧洲药典的国家所认可,如很多欧盟以外的欧洲国家、澳大利亚和中国。CEP证书能够替代EDMF文件用于药品上市申请和原料药来源的变更申请。在该子模块,可以查询CEP认证的流程和费用...
and if any expected changes for CEP revision have been submitted, an inspection attestation is delivered, stating the compliance with the CEP and with the GMP • A GMP Certificate should be issued by the participating Inspectorate (EMA/INS/GMP/459921/2010 Rev 13 Compilation of Community ...
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; ...