某制药公司车间工艺设备清洗验证方案(DOC 46页)

1.......目的......3
2.......范围......3
3.......职责......3
4.......参考文件......4
5.......术语与缩写......4
6.......文件管理规范......5
7.......系统描述......5
8.......取样点风险分析......8
9.......清洗品种的评估......22
10.......取样程序......23
11.......可接受标准......24
12.......分析方法......25
13.......验证说明及检测方法说明......26
14.......清洗验证过程中的注意事项和责任分工......27
15.......监控及再验证阶段......27
16.......测试列表......28
17.......人员确认......29
18.......测试程序......29
18.1......先决条件确认......29
18.2......文件确认......29
18.3......仪器仪表检查......30
18.4......清洗过程确认......30
18.5......目视检查结果确认......31
18.6......棉签法化学取样检测......31
18.7......棉签法微生物取样检测......32
19.......偏差报告......34
20.......附件清单......34
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