吉林四环制药有限公司 部门Department：针剂车间 页数Page：共 15 页 文件编号Docu mentation Nu mber： URS-1120·301-00 起草者 Originator： 汪延广 用 户 需 求 说 明 书 Use Requ irement Specification 安瓿瓶全自动异物侦检机 Ampou le bottle au tomatic foreign matter detecting machine URS-1120·301-00 ---------制药有限公司 2 o f 15 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. 编号 Documentation Number URS-1120·301-00 文件名称 File Name 安瓿瓶全自动异物侦检机用户需求说明书 版本号 Version No. 00 开始 生效日期 Effective date 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 生效日期 Effective date 00 无 新文件 URS-1120·301-00 ---------制药有限公司 3 o f 15 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 5. ...
