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凍干粉針劑、普通粉針劑車(chē)間獲新版GMP認證

發(fā)布時(shí)間：

2015-03-18

2013年12月23日，我公司凍干粉針劑、普通粉針劑車(chē)間，在順利通過(guò)《藥品生產(chǎn)質(zhì)量管理規范(2010年修訂)》要求的一系列檢查及考核后，正式獲得國家食品藥品監督管理總局(SFDA)頒發(fā)的新版GMP證書(shū)。 13 與98版GMP相比，新版GMP對企業(yè)的軟、硬件提出了更高的標準，加強了藥品生產(chǎn)質(zhì)量管理體系建設，大幅提高了對企業(yè)質(zhì)量軟件方面的要求，進(jìn)一步完善了藥品安全保障措施。并引入了質(zhì)量風(fēng)險管理等全新概念，真正實(shí)現了與國際先進(jìn)質(zhì)量管理水平的接軌。 14 我公司此次通過(guò)新版GMP認證，再一次證明安徽先鋒制藥的生產(chǎn)質(zhì)量管理水平已達到國內領(lǐng)先水平，為公司下一步通過(guò)更高標準的美國FDA制劑認證，積累了寶貴經(jīng)驗。

2013年12月23日，我公司凍干粉針劑、普通粉針劑車(chē)間，在順利通過(guò)《藥品生產(chǎn)質(zhì)量管理規范(2010年修訂)》要求的一系列檢查及考核后，正式獲得國家食品藥品監督管理總局(SFDA)頒發(fā)的新版GMP證書(shū)。

與98版GMP相比，新版GMP對企業(yè)的軟、硬件提出了更高的標準，加強了藥品生產(chǎn)質(zhì)量管理體系建設，大幅提高了對企業(yè)質(zhì)量軟件方面的要求，進(jìn)一步完善了藥品安全保障措施。并引入了質(zhì)量風(fēng)險管理等全新概念，真正實(shí)現了與國際先進(jìn)質(zhì)量管理水平的接軌。

我公司此次通過(guò)新版GMP認證，再一次證明安徽先鋒制藥的生產(chǎn)質(zhì)量管理水平已達到國內領(lǐng)先水平，為公司下一步通過(guò)更高標準的美國FDA制劑認證，積累了寶貴經(jīng)驗。

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