APIC 原料药亚硝胺风险评估报告模板-(中英文对照版)VIP免费

Page 1 of 9REPORT ON THE RISK OF POTENTIAL PRESENCEOF NITROSAMINE IMPURITIES关于潜在存在亚硝胺杂质的风险报告Document 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 behalf of the company they represent.签字人明确承认，本报告所载的所有信息均以当前的知识为基础，其实际知识是真实和真诚的，考虑了供应商提供的 现有信息，以及在供应商未能提供信息的情况下可能的化学品生产过程。签字人进一步确认，他/她有权代表其所代表 的公司行事。The information in this document may be updated as more information becomes available. 随着更多信息的出现，本文档中的信息可能会被更新。Date, Signature and Company stamp日期、签名及公司盖章A sector group of Cefic 电European Chemical Industry Council - Cefic aisblDocument ID:Page 2 of 9Delete this page when issuing the letter.发信时删除此页。Instruc...