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1、無菌制劑GMP實(shí)施指南目錄目錄?1.前言.............................................................................................................................................1?1.1?背景?................................................................................................
2、...................................?1?1.1.1?指南說明?.................................................................................................................?1?1.1.2?法規(guī)背景?..........................................................................................
3、.......................?1?1.1.3?技術(shù)背景?.................................................................................................................?1?1.2?范圍?..........................................................................................................
4、.........................?2?2.質(zhì)量管理......................................................................................................................................4?3.人員............................................................................................
5、...............................................34?3.1無菌藥品生產(chǎn)對(duì)人員的基本要求和原則?.......................................................................?34?3.1.1?人員的培訓(xùn)?...........................................................................................................?
6、34?3.1.2?人員衛(wèi)生?...............................................................................................................?35?3.1.3?人員監(jiān)測(cè)計(jì)劃?.......................................................................................................?36?3.1.4?實(shí)驗(yàn)室人員?.....
7、......................................................................................................?37?3.2?關(guān)鍵區(qū)域人員的良好行為規(guī)范?......................................................................................?37?3.3?無菌區(qū)著裝和更衣確認(rèn)?.....................................
8、.............................................................?39?4.廠房設(shè)施...................................................................
