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1、廠房設(shè)備GMP實(shí)施指南目錄目錄1廠房設(shè)計(jì).......................................................................................................................................11.1概述...................................................................................................................................11.1.
2、1藥品生產(chǎn)受控環(huán)境的基本要求.............................................................................21.1.2一般技術(shù)要求.........................................................................................................21.2廠址選擇和廠區(qū)總體布局..........................................................................
3、......................81.3生產(chǎn)區(qū)..............................................................................................................................111.4包裝區(qū)..............................................................................................................................151.5儲(chǔ)存區(qū)
4、..............................................................................................................................171.6質(zhì)量控制區(qū)......................................................................................................................191.7輔助區(qū)...................................
5、............................................................................................271.8人流和物流......................................................................................................................312設(shè)備........................................................................
6、....................................................................372.1概述..................................................................................................................................372.2設(shè)備設(shè)計(jì)選型.................................................................................
7、..................................472.3設(shè)備設(shè)計(jì)、制造、安裝確認(rèn)...........................................................................................572.4設(shè)備技術(shù)資料管理...............................................................
