年度產(chǎn)品質(zhì)量回顧分析實施報告

1、.資料年度產(chǎn)品質(zhì)量回顧分析報告產(chǎn)品名稱:復(fù)方甘草片規(guī)格：100片瓶15瓶盒20盒箱50片300瓶箱24片2板盒10盒收縮膜30條箱回顧日期：2011年07月01日－2012年07月30日起草：QA簽名時間：審核：QA負責(zé)人簽名時間：批準：質(zhì)量受權(quán)人簽名時間：.資料7.5收率（附表2）..............................................................................

2、...................137.6返工與再加工....................................................................................................138偏差回顧：..................................................................................

3、.............................149超常超限回顧：.......................................................................................................1410產(chǎn)品穩(wěn)定性考察：..................................................................

4、.........................1411拒絕批次：.......................................................................................................1411.1拒絕的物料........................................................................

5、..............................1411.2拒絕的成品及中間產(chǎn)品..................................................................................1512變更控制回顧：.................................................................................

6、..................1513驗證回顧：...........................................................................................................1514環(huán)境監(jiān)測情況回顧：.........................................................................

7、..................1615人員情況：.............................................................................................................1616委托加工、委托檢驗情況回顧：..................................................................

8、.......1617不良反應(yīng)：.............................................................................................................1718產(chǎn)品召回、退貨：...................................................................................

9、........1718.1產(chǎn)品召回..........................................................................................................1718.2退貨........................................................................................

10、..........................1719投訴：.....................................................................................................................1720藥品注冊相關(guān)變更的申報、批準及退審.................................................

11、............1721結(jié)論：.....................................................................................................................1722建議：.............................................................................