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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.....................................................................................................................
2、..............11.1.1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).............................................................................
4、.................................................151.5儲存區(qū)..............................................................................................................................171.6質(zhì)量控制區(qū).....................................................................................
5、.................................191.7輔助區(qū)...............................................................................................................................271.8人流和物流....................................................................................................
6、..................312設(shè)備............................................................................................................................................372.1概述............................................................................................................
7、......................372.2設(shè)備設(shè)計(jì)選型...................................................................................................................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.........
8、......................................................
