提取車間生產(chǎn)線清潔驗證方案

1、四川宇妥藏藥股份有限公司YTTS6213A00第1頁共41頁藥品生產(chǎn)質(zhì)量管理文件起草：日期：審核：日期：批準：日期：生效日期：頒發(fā)部門：質(zhì)量部拷貝號：變更記載修訂號批準日期生效日期變更內(nèi)容000102質(zhì)量部QA[]質(zhì)量部QC[]提取前處理車間[]固體制劑車間[]動力維修室[]采購倉儲部[]行政部[]銷售部[]分發(fā)部門財務(wù)部[]提取車間生產(chǎn)線清洗驗證方案提取車間生產(chǎn)線清洗驗證方案四川宇妥藏藥股份有限公司YTTS6213A00第3頁共41頁

2、藥品生產(chǎn)質(zhì)量管理文件目錄目錄1概述................................................................................................................................................................................41.1產(chǎn)品相關(guān)信息.................

3、....................................................................................................................................41.2生產(chǎn)設(shè)備信息..............................................................................

4、.......................................................................42驗證目的...............................................................................................................................................

5、.........................53驗證范圍........................................................................................................................................................................54引用標準...............

6、.........................................................................................................................................................55驗證管理.............................................................

7、.........................................................................................................55.1驗證計劃...........................................................................................................

8、..................................................55.2驗證小組人員名單.............................................................................................................................................55.3驗證小組職責矩陣.....

9、........................................................................................................................................65.4驗證記錄和數(shù)據(jù).........................................................................

10、........................................................................65.5驗證文件要求..........................................................................................................................................

11、...........66設(shè)備的清潔程序............................................................................................................................................................77風險評估......................................

12、..................................................................................................................................78最難清洗關(guān)鍵部位................................................................................

13、........................................................................79驗證原理..............................................................................................................................................

14、..........................810清潔驗證項目..............................................................................................................................................................811驗證方法及接受標準...............

15、...................................................................................................................................911.1目檢..................................................................................

16、.................................................................................911.1.1設(shè)備整體目檢..............................................................................................................................

17、..........911.1.2棉簽取樣目檢........................................................................................................................................911.1.3顏色比對目檢................................................

18、......................................................................................1011.2化學檢驗取樣..........................................................................................................................

19、.......................1011.2.1PH值測試.............................................................................................................................................1011.2.2終淋水不揮發(fā)物檢測..........................

20、................................................................................................1011.2.3TOC檢測...............................................................................................................

21、...............................1012取樣方法....................................................................................................................................................................1012.1棉簽擦拭法......

22、...............................................................................................................................................1012.2淋洗法....................................................................

23、.........................................................................................1112.3樣品編號原則.......................................................................................................................

24、..........................1113檢驗.............................................................................................................................................................................1114清潔驗證執(zhí)行.....

25、.......................................................................................................................................................1114.13m3多功能提取罐清潔驗證..................................................

26、.....................................................................1214.2提取液儲罐清潔驗證...................................................................................................................................1514.

27、3雙效節(jié)能濃縮器清潔驗證...........................................................................................................................1814.4高位貯罐清潔驗證.......................................................................

28、................................................................2114.5醇沉罐清潔驗證...........................................................................................................................................2414

29、.6單效濃縮器清潔驗證.....................................................................................................................................2714.7上清液緩沖罐清潔驗證............................................................

30、.....................................................................3014.81000L配制罐清潔驗證..................................................................................................................................331

31、4.9中藥浸膏噴霧干燥機清潔驗證.....................................................................................................................3615有效期的驗證.............................................................................

32、...............................................................................3916偏差報告.....................................................................................................................................

33、...............................3917驗證結(jié)果評價與建議................................................................................................................................................4018再驗證.........................