某滴眼液工藝驗證方案(DOC 40頁)

1、.......概述.......4
1.1.......產品簡介.......4
1.2.......驗證原因及目的.......4
1.3.......驗證類型.......4
1.4.......風險評估.......4
1.5.......計劃驗證時間.......4
1.6.......驗證依據.......4
2、.......驗證人員及職責.......5
3、.......生產工藝與設備.......6
3.1.......生產工藝處方.......6
3.2.......生產工藝流程圖.......8
3.3.......生產操作過程及工藝條件.......9
3.4.......主要設備一覽表.......11
3.5.......檢驗方法清單.......12
3.6.......關健質量屬性、關健工藝參數及可接受標準.......12
3.7.......產品質量標準.......13
4、.......驗證條件.......14
a).......驗證條件.......14
b).......培訓.......15
5、.......工藝驗證過程.......15
5.1.......無菌低密度聚乙烯藥用滴眼劑瓶外包裝的滅菌和轉運.......16
5.2.......工器具清洗、滅菌與轉運.......17
5.3.......配液.......18
5.4.......灌裝.......20
5.5.......燈檢.......21
6、.......偏差和OOS.......22
7、.......執行的審核和批準.......22
8、.......驗證實施過程中的方案變更管理.......22
9、.......再驗證周期.......23
10、.......取樣計劃表.......23
11、.......驗證結論.......25
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