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1、無菌制劑GMP實(shí)施指南目錄目錄1.前言.............................................................................................................................................11.1背景..................................................................................................
2、.................................11.1.1指南說明.................................................................................................................11.1.2法規(guī)背景..................................................................................................
3、...............11.1.3技術(shù)背景.................................................................................................................11.2范圍........................................................................................................................
4、...........22.質(zhì)量管理......................................................................................................................................43.人員...........................................................................................................
5、................................343.1無菌藥品生產(chǎn)對(duì)人員的基本要求和原則.......................................................................343.1.1人員的培訓(xùn)...........................................................................................................343.1.2人員衛(wèi)生.........
6、......................................................................................................353.1.3人員監(jiān)測(cè)計(jì)劃.......................................................................................................363.1.4實(shí)驗(yàn)室人員..................................
7、.........................................................................373.2關(guān)鍵區(qū)域人員的良好行為規(guī)范......................................................................................373.3無菌區(qū)著裝和更衣確認(rèn)........................................................................
8、..........................394.廠房設(shè)施......................................................................................................................
