【文章內容簡介】 ........................................................................................................................ 67設備 ..........................................................................................................….................... 68消毒 ...........................................................................................................…................... 68加工 ............................................................................................................….................. 68滅菌 ..........................................................................................................….................... 70熱滅菌 .......................................................................................................………........... 70濕熱 ........................................................................................................................…...... 71干熱 .................................................................................................................................. 71輻射滅菌 ..........................................................................................…………................ 71環(huán)氧乙烷滅菌..................................................................................……………….......... 72在最終容器中不能滅菌的藥品的過濾.....…………………………………………....... 73無菌產(chǎn)品的完成 ............................................................................................………...... 73質量控制 .......................................................................................................................... 74附錄2 人用生物制品的生產(chǎn) ................................ .......................................…….........75范圍.................................................................................................................................... 75原則.................................................................................................................…................ 75人員 .................................................................................................................….............. 76廠房設施和設備.......................................................................................................... ………...77動物房和飼養(yǎng) .....................................................................................……….................. 78文件 .....................................................................................................................….....　 78生產(chǎn)................................................................................................................................　 78原輔料.........................................................................................................…………...　 78菌種批和細胞庫系統(tǒng) ..............................................................................……............　 79操作原則 ......................................................................................……….................... 　79質量控制 ...................................................................................................................... 　80附錄3 放射性藥物的生產(chǎn) ...............................................................………………..　. 81原則.................................................................................................................................　 81人員 ...............................................................................................................................　 81廠房設施和設備.......................................................................................................... ……...81生產(chǎn)................................................................................................................................　 82質量控制 ....................................................................................................................... 82銷售和召回 ..................................................................................................……......... 82附錄4 除免疫藥品外獸用藥品的生產(chǎn) ........ ............................................……...　　83藥用和食品混合品的生產(chǎn).................................................... ......................................... 83外寄生蟲殺滅劑的 生產(chǎn)....................................................................................…........ 84獸用藥物的生產(chǎn) ...................................................................... ………………………..84樣品的 留樣..............................................................................................................….. 84無菌獸用藥品 ..................................................................................... ………………...84附錄5 獸用免疫藥品的生產(chǎn) ............................. ……………………………………...85原則................................................................................................................................... 85人員.................................................................................................................................. .85廠房設施................................................................................................................................... 86設備 ............................................................................................................................... ..88動物和動物房..................................................................................................... ………..90消毒–廢物處理 .................................................................................................. ……...90生產(chǎn)................................................................................................................................ …90原輔料 .................................................................................................................... …….90質量控制 .......................................................................................................................... 93附錄6 藥用氣體的生產(chǎn) ....................……………........................................................ 95原則........................................................