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 1 目的..............................................................................................................................................32 范围 .......................................................................................... Error: Reference source not found 3 职责 .............................................................................................................................................. 3 4 验证对象 ...................................................................................................................................... 3 5 验证时间与批次 ...................................................................... Error: Reference source not found 6 验证准备 ................................................................................. Error: Reference source not found 6.1 验证相关确认 ........................................................... Error: Reference source not found 6 。 2 验证文件的确认 ............................................................................................................ 4 6 。 3 相关验证设备 ............................................................ Error: Reference source not found 6.4 人员培训情况确认 ........................................................................................................... 5 6.5 验证所需主要原材料 ................................................... Error: Reference source not found 6.6 产品处方及工艺流程 ................................................... Error: Reference source not found 7. 生产系统要素的评价 .............................................................. Error: Reference source not found 7.1 生产准备间和设备的确认 ..........................................
