TSE声明模板分析和总结.docxVIP

PAGE PAGE 1 TSE 声明 TSE Statement 疯牛病的学名为牛海绵状脑病，其病理特点是大脑海绵状病变。与疯牛病具有共同的病原和病理变化的疾病，统称为海绵状脑病，或可传染性海绵状脑病。 The formal name of mad cow disease is Bovine Spongiform Encephalopathy (BSE), which is characterized by a degeneration of brain tissue giving a sponge-like appearance. All diseases with same source and pathological changes as BSE are collectively called Spongiform Encephalopathy, or Transmissible Spongiform Encephalopathies (TSEs) TSE 声明具有以下的共同特征：The common characteristics of TSE include: 1、病理变化均为大脑皮层神经元细胞退化、丢失、空泡样变形，形成海绵状改 变； Pathological changes include neuronal degradation, loss, vacuolated deformation and spongiform change formation; 2、临床上均有痴呆、共济失调、震颤等症状； Clinical signs include dementia, ataxia, tremor, etc.; 3、都有慢性、退化性、致死性神经系统疾病 They are all chronic, degenerate, fatal nervous system diseases. 基于上述原因 EP EMEA 指南 EMEA/410/01rev.2 中关于“降低人用、兽用药品可传染性海绵状脑病（TSE）的风险指南”和欧洲药典 5.2.8“降低 TSE 风险”均对生产过程中使用的物料有明确规定。 Based on above reasons, materials used in production are clearly specified in Note for Guidance on Minimising the Risk of Transmitting Animal Spongiform Encephalopathy Agents via Human and Veterinary Medicinal Products (EMA/410/01 rev.2) and Ph. Eur. 5.2.8 Minimising the Risk of Transmitting Animal Spongiform Encephalopathy. 因此我公司在此郑重声明，我公司向贵公司提供的产品 ： Therefore, we hereby certify that for materials supplied to your company, : 1、在生产过程中并未使用来自动物组织或人源的物质或成分； Do not use materials of animal and/or of human origin during production; 2、在生产过程中并未使用来自动物组织或人源的辅料、试剂； Do not use excipient or reagents of animal and/or of human origin during production; 3、在生产过程及成品储运时均未使用接触动物组织或人源的设备、设施； Do not use equipment or facilities in contact with materials of animal and/or of human origin during production, storage and transportation. 4、在生产过程中未使用任何反刍动物类衍生材料或任何反刍动物类产品。 Do not use any derivatives or products of ruminants during production. 结论：我公司 不具有 TSE/BSE 风险。 Conclusion: we have no TSE/BSE risk. 姓名： Name: 职务： Position: 公 司 名 称 ： Name of company: 公司生产地址： Address of Manufacturer: 时间： Da