某製藥公司車間工藝設備清洗驗證方案(DOC 46頁)

1.......目的......3
2.......範圍......3
3.......職責......3
4.......參考文件......4
5.......術語與縮寫......4
6.......文件管理規範......5
7.......係統描述......5
8.......取樣點風險分析......8
9.......清洗品種的評估......22
10.......取樣程序......23
11.......可接受標準......24
12.......分析方法......25
13.......驗證說明及檢測方法說明......26
14.......清洗驗證過程中的注意事項和責任分工......27
15.......監控及再驗證階段......27
16.......測試列表......28
17.......人員確認......29
18.......測試程序......29
18.1......先決條件確認......29
18.2......文件確認......29
18.3......儀器儀表檢查......30
18.4......清洗過程確認......30
18.5......目視檢查結果確認......31
18.6......棉簽法化學取樣檢測......31
18.7......棉簽法微生物取樣檢測......32
19.......偏差報告......34
20.......附件清單......34
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