https://health.ec.europa.eu/medicinal-products/eudralex/eudralex-volume-4_en
作为全球领先的数据管理技术供应商,Eurotherm设计了一个解决方案,通过提供成本效益高、易于鉴定和维持良好制造流程的现成监控解决方案和冗余控制解决方案,帮助OEM和最终用户满足附录1第8.50点的要求。 了解Eurotherm如何帮助遵守EudraLex附录1第8.50点 >
The FDA’s 21 CFR Part 11 and the EU’s EudraLex Volume 4 Annex 11 outline standards for electronic records and signatures in GMP-regulated industries. These regulations ensure that electronic documentation is as reliable and secure as paper-based systems, facilitating...
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 1 Manufacture of Sterile Medicinal Products (corrected version) Document History Previous version dated 30 May 2003, in ...
10、so be taken into account.本附件描述的相关原则,既适用于用于生产医药产品的厂房、设施,设备以及工艺的确认与验证活动,也可用于在欧盟药品监管法规(Eudralex)第四卷第二部分没有导入附加要求的活性物质的补充可选指南。 GMP要求企业在贯穿产品和工艺的生产周期过程中通过确认与验证控制有关操作的关键要素。任何...
Annex 1 to EU GMP provides detailed information for the manufacture of sterile medicinal products; it supports the core chapters of EU GMP It is the first annex of EudraLex "The Rules Governing Medicinal Products in the European Union" and it forms part of Volume 4 of the Europ...
EU GMP http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol4_en.htm PIC/ S http://.picscheme/ FDA (Aseptic Processing guide) http://.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/U CM070342.pdf
it represents the consensus thoughts of a group that those regulators participate in. The guidance shares a similar flow and organization with the EU EudraLex Volume 4 Guidelines on Good Manufacturing Practice specific to Advanced Therapy Medicinal Products. Since the publishing of Volume 4 there has...