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).doc

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).docDocume nt ID:
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REPORT ON THE RISK OF POTENTIAL PRESENCE
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OF NITROSAMINE IMPURITIES
关于潜在存在亚硝***杂质
的风险报告
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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***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.
随着更多信息的岀现，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
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A sector group of Cefic •
EuinopeM ChcnWoi Ihdusiry Cauncl 亠 Crik aJsbl
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/ I / / I .,
Delete this page when issuing the letter.
发信时删除此页。
In struct ions whe n using this template.
使用此模板时的说明。
Replace APIC logo by your company logo.
将APIC的logo替换为贵公司的logo。
In the footer, replace CEFIC logo by “This document Wasedepiared
APIC template ”.
在页脚，使用 此文件基于APIC模板编写”代替CEFIC logo。
't ap
In various places in the template,