J9九游会AG

J9九游会AG

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贵州J9九游会AG药业有限责任公司

贵州J9九游会AG药(yao)业有(you)(you)限责任公司(si)始建(jian)于(yu)1995年(nian)3月,生(sheng)产(chan)(chan)(chan)地址位于(yu)贵阳国家高新技(ji)(ji)术产(chan)(chan)(chan)业开发区金阳知识产(chan)(chan)(chan)业园。于(yu)1998年(nian)投(tou)资建(jian)设, 2001年(nian)正式投(tou)产(chan)(chan)(chan),占地面积(ji)20000㎡,绿(lv)化面积(ji)13000㎡,建(jian)筑面积(ji)12229㎡,企业现有(you)(you)员(yuan)工82 人(ren),各类专业技(ji)(ji)术人(ren)员(yuan)占26%。公司(si)拥有(you)(you)有(you)(you)喷雾(wu)剂(ji)、片(pian)剂(ji)、胶(jiao)(jiao)囊(nang)(nang)剂(ji)、颗(ke)粒(li)剂(ji)四种(zhong)剂(ji)型,共有(you)(you)无菌(jun)制剂(ji)生(sheng)产(chan)(chan)(chan)线和(he)口服固体(ti)制剂(ji)生(sheng)产(chan)(chan)(chan)线各一(yi)条。曾先后3次通过(guo)《药(yao)品(pin)生(sheng)产(chan)(chan)(chan)质(zhi)量管理规范(1998年(nian)修订)》的认证(zheng)、复认证(zheng)。公司(si)成立至今,注重新产(chan)(chan)(chan)品(pin)的开发和(he)研(yan)究,从2002到现在(zai),已(yi)取得药(yao)品(pin)批准文号(hao)24个,全部都在(zai)有(you)(you)效期(qi)内;一(yi)个中(zhong)药(yao)六类新药(yao),已(yi)结束临床试验进(jin)入(ru)生(sheng)产(chan)(chan)(chan)申报(bao)阶段。常(chang)年(nian)生(sheng)产(chan)(chan)(chan)品(pin)种(zhong)有(you)(you):伤科灵喷雾(wu)剂(ji)、痹(bi)痛宁胶(jiao)(jiao)囊(nang)(nang)、克痹(bi)骨泰胶(jiao)(jiao)囊(nang)(nang)、芩连(lian)胶(jiao)(jiao)囊(nang)(nang)、愈伤灵胶(jiao)(jiao)囊(nang)(nang)等。

 

为了(le)(le)实(shi)现企业(ye)的总体(ti)发展目(mu)标,于(yu)2014年(nian)3月先(xian)期投资2000多(duo)(duo)万元,在原(yuan)址新建了(le)(le)喷(pen)雾剂车间(jian)及各种设(she)(she)施、设(she)(she)备。该生产线(xian)已于(yu)2015年(nian) 03月通过GMP认(ren)证(zheng),并获得了(le)(le)新版GMP认(ren)证(zheng)证(zheng)书。口(kou)服固体(ti)制剂生产线(xian)于(yu)今年(nian)上半年(nian)投资1500多(duo)(duo)万元进(jin)行原(yuan)址新建,并按GMP规范(fan)新建成综合车间(jian)(含中药前提)及其它配(pei)套设(she)(she)施。

 

厂区现在建筑总面(mian)(mian)(mian)积(ji)(ji)(ji)(ji)12229平(ping)(ping)方米(mi)(mi)(mi)(mi),其(qi)中(zhong)(zhong)(zhong)(zhong)行(xing)政(zheng)办公区面(mian)(mian)(mian)积(ji)(ji)(ji)(ji)1200平(ping)(ping)方米(mi)(mi)(mi)(mi),职(zhi)工(gong)(gong)宿舍面(mian)(mian)(mian)600平(ping)(ping)方米(mi)(mi)(mi)(mi),后勤保(bao)障面(mian)(mian)(mian)积(ji)(ji)(ji)(ji)856平(ping)(ping)方米(mi)(mi)(mi)(mi),公用(yong)工(gong)(gong)程(cheng)面(mian)(mian)(mian)积(ji)(ji)(ji)(ji)750平(ping)(ping)方米(mi)(mi)(mi)(mi),质(zhi)(zhi)量(liang)管理面(mian)(mian)(mian)积(ji)(ji)(ji)(ji)670平(ping)(ping)方米(mi)(mi)(mi)(mi)(质(zhi)(zhi)量(liang)保(bao)证面(mian)(mian)(mian)积(ji)(ji)(ji)(ji)324平(ping)(ping)方米(mi)(mi)(mi)(mi),质(zhi)(zhi)量(liang)控制(zhi)面(mian)(mian)(mian)积(ji)(ji)(ji)(ji)346平(ping)(ping)方米(mi)(mi)(mi)(mi)),前(qian)处理楼面(mian)(mian)(mian)积(ji)(ji)(ji)(ji)783平(ping)(ping)方米(mi)(mi)(mi)(mi)(浸渍(zi)面(mian)(mian)(mian)积(ji)(ji)(ji)(ji)286平(ping)(ping)方米(mi)(mi)(mi)(mi),中(zhong)(zhong)(zhong)(zhong)药(yao)提(ti)取面(mian)(mian)(mian)积(ji)(ji)(ji)(ji)108平(ping)(ping)方米(mi)(mi)(mi)(mi),膏粉(fen)面(mian)(mian)(mian)积(ji)(ji)(ji)(ji)216平(ping)(ping)方米(mi)(mi)(mi)(mi),原生(sheng)(sheng)(sheng)药(yao)粉(fen)面(mian)(mian)(mian)积(ji)(ji)(ji)(ji)173平(ping)(ping)方米(mi)(mi)(mi)(mi);D级(ji)(ji)(ji)净(jing)化面(mian)(mian)(mian)积(ji)(ji)(ji)(ji) 216平(ping)(ping)方米(mi)(mi)(mi)(mi)),制(zhi)剂(ji)生(sheng)(sheng)(sheng)产(chan)楼面(mian)(mian)(mian)积(ji)(ji)(ji)(ji)5450平(ping)(ping)方米(mi)(mi)(mi)(mi)(喷雾剂(ji)生(sheng)(sheng)(sheng)产(chan)面(mian)(mian)(mian)积(ji)(ji)(ji)(ji)750平(ping)(ping)方米(mi)(mi)(mi)(mi),口服固体(ti)制(zhi)剂(ji)生(sheng)(sheng)(sheng)产(chan)面(mian)(mian)(mian)积(ji)(ji)(ji)(ji)1360平(ping)(ping)方米(mi)(mi)(mi)(mi);D级(ji)(ji)(ji)净(jing)化面(mian)(mian)(mian)积(ji)(ji)(ji)(ji) 1020平(ping)(ping)方米(mi)(mi)(mi)(mi),C级(ji)(ji)(ji)净(jing)化面(mian)(mian)(mian)积(ji)(ji)(ji)(ji) 320平(ping)(ping)方米(mi)(mi)(mi)(mi),B+A级(ji)(ji)(ji)净(jing)化面(mian)(mian)(mian)积(ji)(ji)(ji)(ji) 220平(ping)(ping)方米(mi)(mi)(mi)(mi)),仓储面(mian)(mian)(mian)积(ji)(ji)(ji)(ji)1920平(ping)(ping)方米(mi)(mi)(mi)(mi),固定资(zi)产(chan)投资(zi)6000余万元。公司(si)现设有销(xiao)售、财务、企管(含人(ren)(ren)(ren)事和行(xing)政(zheng))、GMP办、质(zhi)(zhi)量(liang)(含质(zhi)(zhi)量(liang)保(bao)证与控制(zhi))、工(gong)(gong)程(cheng)、物资(zi)、生(sheng)(sheng)(sheng)产(chan)八(ba)个二级(ji)(ji)(ji)部门。现有员(yuan)(yuan)工(gong)(gong)82人(ren)(ren)(ren),其(qi)中(zhong)(zhong)(zhong)(zhong)研究生(sheng)(sheng)(sheng)1人(ren)(ren)(ren),本(ben)科生(sheng)(sheng)(sheng)14人(ren)(ren)(ren),专科生(sheng)(sheng)(sheng)21人(ren)(ren)(ren),中(zhong)(zhong)(zhong)(zhong)专生(sheng)(sheng)(sheng)22人(ren)(ren)(ren),占职(zhi)工(gong)(gong)总人(ren)(ren)(ren)数(shu)的71%;技(ji)术(shu)(shu)人(ren)(ren)(ren)员(yuan)(yuan)18人(ren)(ren)(ren),占职(zhi)工(gong)(gong)总人(ren)(ren)(ren)数(shu)的22%;其(qi)中(zhong)(zhong)(zhong)(zhong)高级(ji)(ji)(ji)职(zhi)称(cheng)(cheng)技(ji)术(shu)(shu)人(ren)(ren)(ren)员(yuan)(yuan)5人(ren)(ren)(ren),中(zhong)(zhong)(zhong)(zhong)级(ji)(ji)(ji)职(zhi)称(cheng)(cheng)技(ji)术(shu)(shu)人(ren)(ren)(ren)员(yuan)(yuan)10人(ren)(ren)(ren),占职(zhi)工(gong)(gong)总人(ren)(ren)(ren)数(shu)的18%,初级(ji)(ji)(ji)职(zhi)称(cheng)(cheng)技(ji)术(shu)(shu)人(ren)(ren)(ren)员(yuan)(yuan)19人(ren)(ren)(ren),执业药(yao)师 1人(ren)(ren)(ren)。公司(si)所有关键(jian)岗位均由符合条件的人(ren)(ren)(ren)员(yuan)(yuan)担任,能达到(dao)全(quan)面(mian)(mian)(mian)控制(zhi)产(chan)品质(zhi)(zhi)量(liang)的目的。

 

公(gong)(gong)司(si)依(yi)据《药品生(sheng)产(chan)质(zhi)量(liang)管理(li)规范》(2010年修订)的规定(ding),结合所(suo)产(chan)剂(ji)型(xing)及(ji)各品种工(gong)艺物料(liao)特(te)点和(he)(he)公(gong)(gong)司(si)各方面方实际情况(kuang),编制了质(zhi)量(liang)管理(li)体系(xi)(xi)的系(xi)(xi)列(lie)管理(li)软件。确定(ding)了公(gong)(gong)司(si)的质(zhi)量(liang)方针和(he)(he)目标(biao),制定(ding)了一系(xi)(xi)列(lie)的标(biao)准和(he)(he)管理(li)程序,建立(li)健全了一体化的可(ke)持(chi)续改进的公(gong)(gong)司(si)质(zhi)量(liang)管理(li)体系(xi)(xi)。

 

贵州J9九游会AG药业有限责任公司