ANNEX13 Manufactureofinvestigationalmedicinal products JULY2003 ANNEX13REVISION1 PRINCIPLE Investigationalmedicinalproductsshouldbeproducedinaccordancewiththeprinciplesand thedetailedguidelinesofGoodManufacturingPracticeforMedicinalProducts(TheRules GoverningMedicinalProductsinTheEuropeanCommunity,VolumeIV).Otherguidelines publishe...
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 ...
EU-GMP-Part-II-Annexes-13.pdf 热度: Exhibition-of-Master-Wan-Ko-Yee's-Amazing-Achievement-in-the-Form-of-World-Class-Treasures 热度: 111 ANNEX11 COMPUTERISEDSYSTEMS Principle Theintroductionofcomputerisedsystemsintosystemsofmanufacturing,including ...
between themanufacturerand thesponsor, if different,in a timely manner"(the previous Annex 13 also...
(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 ...
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) ...
Annex 12 Use of Ionising Radiation in the Manufacture of Medicinal Products Annex 13 Manufacture of Investigational Medicinal Products Annex 14 Manufacture of Products derived from Human Blood or Human Plasma Annex 15 Qualification and validation (July 2001) ...
基于现行Annex1中对于PUPSIT的要求,我们需要对过滤器组件进行灭菌后使用前完整性测试,这就需要我们在设计过滤链时将这个需求考量在内,保障在后续操作过程中包括但不限于润湿,完整性测试以及吹扫等步骤的无菌性就显得至关重要。常见的设计方式包含了主过滤器下游增加储罐/冲洗袋加呼吸器或是使用屏障式过滤器的设计方式。
内容提示: I n t e r p r e t a t i o n G M P A n n e x 1 T e c h n i c a l I n t e r p r e t a t i o n QMI-Ident: I-SMI.TI.25e / V1.0 / hba / cfe / smi / 31.10.2023 1/25 Printed on 06.11.23 Interpretation of GMP Annex 1 2022 (Rev. 1)...