between themanufacturerand thesponsor, if different,in a timely manner"(the previous Annex 13 also...
ANNEX13 Manufactureofinvestigationalmedicinal products JULY2003 ANNEX13REVISION1 PRINCIPLE Investigationalmedicinalproductsshouldbeproducedinaccordancewiththeprinciplesand thedetailedguidelinesofGoodManufacturingPracticeforMedicinalProducts(TheRules GoverningMedicinalProductsinTheEuropeanCommunity,VolumeIV).Otherguidelines ...
COMEUR Brussels.EUROPEAN COMMISSIONENTERPRISE DIRECTORATE-GENERALSingle market : management & legislation for consumer goodsPharmaceuticals : regulatory framework and market authorisationsBrussels,F2/BL D(2003)Revision 1VOLUME 4Good manufacturing practicesANNEX 13Manufacture of investigational medicinalproductsJULY ...
ANNEX13REVISION1 PRINCIPLE Investigationalmedicinalproductsshouldbeproducedinaccordancewiththeprinciplesand thedetailedguidelinesofGoodManufacturingPracticeforMedicinalProducts(TheRules GoverningMedicinalProductsinTheEuropeanCommunity,VolumeIV).Otherguidelines publishedbytheEuropeanCommissionshouldbetakenintoaccountwhererelevantanda...
(2010) 3374 EudraLex The Rules Governing Medicinal Products in the European Union Volume 4 EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use Annex 13 Investigational Medicinal Products Document History Revision to reinforce the principle of independence between ...
Detailed Guidelines "on Good Manufacturing Practice for Investigational Medicinal Products for human use, pursuant to the second subparagraph of Article 63(1) of Regulation (EU) No 536/2014" (replaces Annex 13 of the GMP Guidelines) “依法规(EU)No...
◆根据统计,中国2010版GMP附录目前包括正式发布的13个附录。处于征求意见状态的是1个,即2022年再次征集意见的《细胞治疗产品附录》。 ◆中国2010版GMP附录体系还不健全,编号体系至今未建立,导致技术沟通有阻碍。 ◆中国2010版GMP附录中部分附录太陈旧,例如附录1在2011年...
According to EudraLex Volume 4 and its Annex and The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), QP has conducted the on-site inspections on the drug substance (DS) line, drug product (DP) line and quality management system of ...
Annex 13 (Manufactureofinvestigationalmedicinalproducts) 临床试验用药品的生产 Annex 14 (Manufactureofmedicinalproductsderivedfromhumanbloodorplasma) 源自人体血液或血浆的医药产品的生产 Annex 15 (Qualificationandvalidation) 确认和验证 Annex 16 (Authorisedpersonandbatchrelease) ...