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新版GMP注射劑車(chē)間建設如火如荼

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2015-03-18

2011年2月12日，《藥品生產(chǎn)質(zhì)量管理規范(2010年修訂)》(簡(jiǎn)稱(chēng)新版GMP)正式發(fā)布實(shí)施，新版GMP要求無(wú)菌制劑生產(chǎn)必須在2013年12月30日前完成改造并通過(guò)認證。為貫徹實(shí)施新版GMP，公司于2012年7月立項上馬“新版GMP注射劑車(chē)間暨注射劑生產(chǎn)車(chē)間技術(shù)改造項目”。該項目位于安徽省先鋒制藥有限公司內預留地塊，新增建筑面積10880平方米，新建普通粉針和凍干粉針生產(chǎn)線(xiàn)各一條，并對動(dòng)力設施、蒸氣熱力管道等公用系統進(jìn)行改造。項目總投資6000萬(wàn)元，預計達產(chǎn)后可實(shí)現年產(chǎn)粉針劑7290萬(wàn)支、凍干粉針劑3240萬(wàn)支，年銷(xiāo)售收入達3億元。該項目已于2012年7月破土動(dòng)工，目前土建工程已基本結束開(kāi)始進(jìn)入緊張的設備安裝調試階段，項目預計將于2013年8月全部完工，2013年9月公司將申報國家食品藥品監督管理局(SFDA)的新版GMP認證。

2011年2月12日，《藥品生產(chǎn)質(zhì)量管理規范(2010年修訂)》(簡(jiǎn)稱(chēng)新版GMP)正式發(fā)布實(shí)施，新版GMP要求無(wú)菌制劑生產(chǎn)必須在2013年12月30日前完成改造并通過(guò)認證。為貫徹實(shí)施新版GMP，公司于2012年7月立項上馬“新版GMP注射劑車(chē)間暨注射劑生產(chǎn)車(chē)間技術(shù)改造項目”。

該項目位于安徽省先鋒制藥有限公司內預留地塊，新增建筑面積10880平方米，新建普通粉針和凍干粉針生產(chǎn)線(xiàn)各一條，并對動(dòng)力設施、蒸氣熱力管道等公用系統進(jìn)行改造。項目總投資6000萬(wàn)元，預計達產(chǎn)后可實(shí)現年產(chǎn)粉針劑7290萬(wàn)支、凍干粉針劑3240萬(wàn)支，年銷(xiāo)售收入達3億元。

該項目已于2012年7月破土動(dòng)工，目前土建工程已基本結束開(kāi)始進(jìn)入緊張的設備安裝調試階段，項目預計將于2013年8月全部完工，2013年9月公司將申報國家食品藥品監督管理局(SFDA)的新版GMP認證。

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