滴眼液工艺验证方案.docVIP

工艺验证方案 品名：xxxx滴眼液规格：5ml：5mg剂型：滴眼剂起草人： 制定日期： 研发审核人： 审核日期： 审核人：审核日期： 批准人：批准日期：文件编号：生效日期：  xxxx制药有限公司 目 录  TOC \o 1-3 \h \z \u  HYPERLINK \l _Toc434225660 1 目的  PAGEREF _Toc434225660 \h 3  HYPERLINK \l _Toc434225661 2 范围  PAGEREF _Toc434225661 \h 3  HYPERLINK \l _Toc434225662 3 职责  PAGEREF _Toc434225662 \h 3  HYPERLINK \l _Toc434225663 4 验证对象  PAGEREF _Toc434225663 \h 3  HYPERLINK \l _Toc434225664 5 验证时间与批次  PAGEREF _Toc434225664 \h 3  HYPERLINK \l _Toc434225665 6 验证准备  PAGEREF _Toc434225665 \h 4  HYPERLINK \l _Toc434225666 6.1验证相关确认  PAGEREF _Toc434225666 \h 4  HYPERLINK \l _Toc434225667 6.2验证文件的确认  PAGEREF _Toc434225667 \h 5  HYPERLINK \l _Toc434225668 6.3相关验证设备  PAGEREF _Toc434225668 \h 5  HYPERLINK \l _Toc434225669 6.4人员培训情况确认  PAGEREF _Toc434225669 \h 6  HYPERLINK \l _Toc434225670 6.5验证所需主要原材料  PAGEREF _Toc434225670 \h 6  HYPERLINK \l _Toc434225671 6.6产品处方及工艺流程  PAGEREF _Toc434225671 \h 6  HYPERLINK \l _Toc434225672 7.生产系统要素的评价  PAGEREF _Toc434225672 \h 9  HYPERLINK \l _Toc434225673 7.1生产准备间和设备的确认  PAGEREF _Toc434225673 \h 9  HYPERLINK \l _Toc434225674 7.2服务设施准备的确认  PAGEREF _Toc434225674 \h 9  HYPERLINK \l _Toc434225675 7.3公用及服务系统准备的确认  PAGEREF _Toc434225675 \h 9  HYPERLINK \l _Toc434225676 7.4洁净区空气净化系统准备的确认  PAGEREF _Toc434225676 \h 10  HYPERLINK \l _Toc434225677 7.5注射用水系统  PAGEREF _Toc434225677 \h 11  HYPERLINK \l _Toc434225678 7.6生产人员  PAGEREF _Toc434225678 \h 11  HYPERLINK \l _Toc434225679 8生产工艺过程验证  PAGEREF _Toc434225679 \h 11  HYPERLINK \l _Toc434225680 8.1瓶（塞）盖灭菌岗位  PAGEREF _Toc434225680 \h 11  HYPERLINK \l _Toc434225681 8.2称量岗位  PAGEREF _Toc434225681 \h 12  HYPERLINK \l _Toc434225683 8.3配液岗位  PAGEREF _Toc434225683 \h 12  HYPERLINK \l _Toc434225685 8.4灌装岗位  PAGEREF _Toc434225685 \h 14  HYPERLINK \l _Toc434225686 8.5灯检岗位  PAGEREF _Toc434225686 \h 14