公司名 图标 部门Department：部非固体车间 页数Page：共 页 文件编号Docu mentation Nu mber： URS-生产线名 -001 作者 Au thor： 用 户 要 求 文 件 Use Requ irement Specification 贴签机用户要求 Labelling machine’s URS URS-生产线名-001 2 o f 16 审核及批准 REVIEW AND APPROVAL 我已阅读本文并确认本方案内容准确无误 I have read this document and confirm to the best of my knowledge the content in this protocol is accurate. 审核 Reviewed by 审核 Reviewed by 审核 Reviewed by 审核 Reviewed by 审核 Reviewed by 批准 Approved by 部门 Department 姓名 Name 文件变更控制 Version Change History 版号 Version No. 修订章节 Updated Section 修订简述 Reversion Description 001 无 新文件 URS-生产线名-001 3 o f 16 目 录 1. 背景介绍 BACKGROUND ............................................................................................. 4 2. 目的 PURPOSE ................................................................................................................ 4 3. 范围 SCOPE ..................................................................................................................... 4 4. 法规和国家标准 REGULATORY AND STATUTORY COMPLIANCE .................. 4 4.1 CGMP 法规 ................................................................................................................ 4 4.2 行业标准 .................................................................................................................... 4 4.3 国家标准 .................................................................................................................... 5 4.4 购买公司的管理要求 ................................................................................................ 5 5. 项目介绍 PROJECT INTRODUCTION ....................................................................... 6 5.1 项目描述 ..........................................................
