APIC原料药亚硝胺风险评估报告模板2020年2月(中英文对照版)

Document ID: 文件ID Page 1 of 9 REPORT ON THE RISK OF POTENTIAL PRESENCE OF NITROSAMINE IMPURITIES 关于潜在存在亚硝胺杂质 的风险报告 Docu ment ID: 文件ID: MATERIAL 物料 Name: ……………………………………………………………………………………………………………………………… 名称 Material code(s) :…………………………………………………………………………………………………………………… 材料代码 MANUFACTURER (refers to the manufacturing site) 制造商(指生产工厂) Name:………………………………………………………………………………………………………………………………… 名称 Address:……………………………………………………………………………………………………………………………… 地址 This report was completed by [person / central service]: 这份报告由[个人/中心事务]完成: ▪ Name and position: …………………………………………………………………………………………………………………………………………….…………………… 姓名和职位 ▪ E-mail address: …………………………………………………………………………………………………………………………………………………………………………. 电邮地址 ▪ Postal address: ………………………………………………………………………………………………………………………………………………………………………… 邮寄地址 Declaration: 声明: The current manufacturing process of (the name of the substance) was assessed with respect to the risk of the presence of Nitrosamine impurities. (该物质的名称)当前生产工艺存在的亚硝胺杂质的风险评估已完成。 The signatory expressly recognizes that all information contained in this report is based on current knowledge and is true and sincere to his / her actual knowledge considering available supplier information and likely chemical production processes where information from the supplier is not available. The signatory further confirms that he / she has the authority to act on beh...