Aseptic processing of health care products. Alternative processes for medical devices and combination products
医疗保健产品的无菌处理 医疗器械和组合产品的替代工艺
发布日期:
2013-02-28
交叉引用:ISO 13408-1:2008 ISO 11137-2ISO 11737-2ISO 13485ISO 14644ISO 14698ISO 14971:20072004/23/EC2005/17/ECEU良好制造规范指南欧洲药典美国药典欧洲药典EMEA/CHMP/410869/2006SG3/N15R8/2005SG3/N99-10ICH工业指南Q9质量风险管理PDA技术报告22(TR22)PDA技术报告44(TR44)PDA技术报告34(TR34)购买本文件时可获得的所有当前修订均包含在购买本文件中。
Cross References:ISO 13408-1:2008ISO 11137-2ISO 11737-2ISO 13485ISO 14644ISO 14698ISO 14971:20072004/23/EC2005/17/ECEU Good Manufacturing Practice DirectiveEuropean PharmacopoeiaUS PharmacopoeiaJP PharmacopoeiaEMEA/CHMP/410869/2006SG3/N15R8/2005SG3/N99-10ICH Guidance for Industry Q9 Quality Risk ManagementPDA Technical Report 22 (TR22)PDA Technical Report 44 (TR44)PDA Technical Report 34 (TR34)All current amendments available at time of purchase are included with the purchase of this document.