每种事项又根据对药品安全性、有效性和质量可控性产生影响的潜在风险,分为三类:重大变更、中等变更、微小变更。而在EDQM递交CEP变更时主要参照的指南为《GUIDELINE ON REQUIREMENTS FOR REVISION/RENEWAL OF CERTIFICATES OF SUITABILITY TO THE EUROPEAN PHARMACOPOEIA MONOGRAP》(2018年9月更新,2019年1月实施)。该指南...
变更分类报告类变更(微小变更或其他)备案类变更(中等变更或其他)审评类变更(重大变更或其他)药典专论升级(结合国家局关于药典升级的通知及所在省份(如有)的相关通知判断属于报告类/备案类/审评类)与左同通知(annual notification)立即通知(immediate notification)微小(minor)重大(major)药典专论升级( monograph revisi...
每种事项又根据对药品安全性、有效性和质量可控性产生影响的潜在风险,分为三类:重大变更、中等变更、微小变更。而在EDQM递交CEP变更时主要参照的指南为《GUIDELINE ON REQUIREMENTS FOR REVISION/RENEWAL OF CERTIFICATES OF SUITABILITY TO THE EUROPEAN PHARMACOPOEIA MONOGRAP》(2018年9月更新,2019年1月实施)。该指南...
grant and revise CEPs. ― 法案AP-CSP (07) 1,CEP 认证程序 ― EDQM “Guideline on Requirements on Revision/Renewal of Certificates of Suitability to the European Pharmacopoeia monographs” (PA/PH/CEP (04) 2), which describes the categorisation of requests to revise CEPs and the conditions ...
“Guideline on Requirements for Revision/renewal of Certificates of Suitability to the European Pharmacopoeia Monographs (PA/PH/CEP (04) )” and may include: - Changes to limits for elemental impurities in the final substance: addition/deletion/tightening/widening - Changes to the method(s) used...
CEP/PA/PH/CEP(04)2,4R执行日期:2010年3月1日欧洲药典适用性证书持有人必须向EDQM报告所有与申报文件有关的变更,申报时应填写申请表格和所有必要的资料,证明变..
斯特拉斯堡，2012年7月 Certification of Suitability toMonographs of the European Pharmacopoeia Guidance on frequent changes to applications for Certificates of Suitability (CEPs)欧洲药典适用性证书常见CEP变更申请指南 Address: 7 allée Kastner CS 30026 - F 67081 Strasbourg Telephone: 33 (0) 3 88 41 30...
The changes related to Ph. Eur. monograph revisions or any other regulatory requirements are treated separately and generally initiated by the EDQM.执行日期：2010年3月1日 介绍：欧洲药典适用性证书持有人必须向EDQM报告所有与申报文件有关的变更，申报时应填写申请表格和所有必要的资料，证明变更符合现行指南...
(04)2,4RStrasbourg,December2009CertificationofsuitabilitytoMonographsoftheEuropeanPharmacopoeiaGuidelineonRequirementsforRevision/RenewalofCertificatesofSuitabilitytotheEuropeanPharmacopoeiamonographsEDQMPA/PH/CEP(04)2,4RCertificationofSubstancesDivisionPage2of19GUIDELINEONREQUIREMENTSFORREVISION/RENEWALOFCERTIFICATESOF...
斯特拉斯堡，2012年7月 Certification of Suitability toMonographs of the European Pharmacopoeia Guidance on frequent changes to applications for Certificates of Suitability (CEPs)欧洲药典适用性证书常见CEP变更申请指南 Address: 7 allée Kastner CS 30026 - F 67081 Strasbourg Telephone: 33 (0) 3 88 41 30...