2013年11月15日寧夏食品藥品監督管理局專家組一行對我公司原料藥許可證變更增加藥品生產許可范圍的情況進行了驗收檢查。 
本次檢(jian)(jian)(jian)(jian)查(cha)內容主要圍繞藥(yao)品(pin)(pin)許(xu)可(ke)證變更增加維生(sheng)(sheng)素B2和(he)(he)腺苷鈷胺(an)事(shi)項的(de)相(xiang)關工作(zuo)開展，檢(jian)(jian)(jian)(jian)查(cha)員(yuan)嚴(yan)格按照2010年版GMP要求和(he)(he)自治區食(shi)品(pin)(pin)藥(yao)品(pin)(pin)監督管(guan)理局(ju)(ju)制定的(de)許(xu)可(ke)證驗收(shou)檢(jian)(jian)(jian)(jian)查(cha)條(tiao)款進行(xing)，在檢(jian)(jian)(jian)(jian)查(cha)過(guo)(guo)程(cheng)中(zhong)檢(jian)(jian)(jian)(jian)查(cha)人(ren)(ren)(ren)員(yuan)通(tong)過(guo)(guo)對(dui)我公(gong)(gong)司在企業負責人(ren)(ren)(ren)、質(zhi)量負責人(ren)(ren)(ren)、生(sheng)(sheng)產(chan)(chan)(chan)和(he)(he)質(zhi)量檢(jian)(jian)(jian)(jian)測人(ren)(ren)(ren)員(yuan)資質(zhi)、生(sheng)(sheng)產(chan)(chan)(chan)廠房、設(she)施(shi)布局(ju)(ju)和(he)(he)環境(jing)衛(wei)生(sheng)(sheng)、生(sheng)(sheng)產(chan)(chan)(chan)工藝布局(ju)(ju)和(he)(he)流程(cheng)、生(sheng)(sheng)產(chan)(chan)(chan)、檢(jian)(jian)(jian)(jian)驗設(she)備儀器管(guan)理和(he)(he)校驗、物料和(he)(he)產(chan)(chan)(chan)品(pin)(pin)倉儲、質(zhi)量管(guan)理文件(jian)和(he)(he)制度建設(she)等方(fang)面進行(xing)文件(jian)查(cha)閱和(he)(he)生(sheng)(sheng)產(chan)(chan)(chan)現場檢(jian)(jian)(jian)(jian)查(cha)，我公(gong)(gong)司符合藥(yao)品(pin)(pin)生(sheng)(sheng)產(chan)(chan)(chan)許(xu)可(ke)相(xiang)關條(tiao)件(jian)和(he)(he)要求。

本次藥(yao)(yao)品(pin)生(sheng)產許(xu)可證(zheng)(zheng)變更增加范(fan)圍的的檢查和驗收(shou)并取得(de)證(zheng)(zheng)書，標志(zhi)著我公(gong)(gong)司(si)維生(sheng)素B2和腺苷(gan)鈷胺具備(bei)(bei)了原料(liao)藥(yao)(yao)的生(sheng)產條件，我公(gong)(gong)司(si)將嚴格按(an)照國家(jia)有關藥(yao)(yao)品(pin)生(sheng)產管理規范(fan)要求積極籌備(bei)(bei)新版(ban)藥(yao)(yao)品(pin)GMP認(ren)(ren)證(zheng)(zheng)檢查工作，爭取早日完成認(ren)(ren)證(zheng)(zheng)并投入生(sheng)產銷售。