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制药洁净厂房建设的法规有哪些?

文章作者:J9九游会AG环境工程 发布时间:

制药洁净厂房近年来建(jian)设(she)得非常多,主(zhu)要是由于行(xing)业的持续扩展,而行(xing)业要求又比较严(yan)格(ge),所以导致这种结果,那么J9九游会AG 在建(jian)设(she)这种厂房需要遵守的法规有哪些?下面J9九游会AG为大家(jia)详细(xi)介绍。

制药(yao)洁(jie)净厂房(fang)建设法规(gui):《药(yao)品微生物实验室规(gui)范指(zhi)导(dao)原(yuan)则》——《药(yao)典2010》—附则XIXQ。1、药(yao)品管(guan)理法。2、药(yao)品法条例(li)全文。3、2010版GMP。4、认(ren)证具体(ti)指(zhi)导(dao)标准2003。5、已(yi)发(fa)售中(zhong)药(yao)材变(bian)动(dong)(dong)科学研究(jiu)具体(ti)指(zhi)导(dao)标准。6、已(yi)发(fa)售中(zhong)药(yao)注射剂变(bian)动(dong)(dong)科学研究(jiu)具体(ti)指(zhi)导(dao)标准。7、中(zhong)药(yao)材申请(qing)注册(ce)方法。8、药(yao)用辅料(liao)管(guan)理条例(li)。

制(zhi)(zhi)药(yao)(yao)洁(jie)净厂房建设规定:必须申(shen)(shen)请(qing)(qing)(qing)(qing)办(ban)理(li)(li)(li)药(yao)(yao)物(wu)(wu)(wu)生产(chan)(chan)许可、企(qi)业(ye)(ye)(ye)营业(ye)(ye)(ye)执照、机构组织代(dai)码(ma)、国(guo)税(shui)局(ju)、地税(shui)局(ju)、特制(zhi)(zhi)工(gong)(gong)艺(yi)流程(cheng)(cheng)(cheng)GMP证(zheng)(zheng)(zheng)(zheng)。1、开设药(yao)(yao)物(wu)(wu)(wu)制(zhi)(zhi)造(zao)(zao)(zao)(zao)业(ye)(ye)(ye)企(qi)业(ye)(ye)(ye)申(shen)(shen)办(ban)人(ren)理(li)(li)(li)应(ying)(ying)向所(suo)在(zai)城市省部(bu)级(ji)(ji)药(yao)(yao)物(wu)(wu)(wu)监(jian)(jian)(jian)(jian)管(guan)单(dan)(dan)位(wei)申(shen)(shen)请(qing)(qing)(qing)(qing)办(ban)理(li)(li)(li)筹备(bei);省部(bu)级(ji)(ji)药(yao)(yao)品(pin)(pin)监(jian)(jian)(jian)(jian)督管(guan)理(li)(li)(li)单(dan)(dan)位(wei)自(zi)接(jie)到申(shen)(shen)请(qing)(qing)(qing)(qing)办(ban)理(li)(li)(li)30个(ge)(ge)工(gong)(gong)作中日(ri)内做出(chu)(chu)是(shi)不是(shi)愿意(yi)筹备(bei)的(de)决策(ce)—申(shen)(shen)请(qing)(qing)(qing)(qing)者进行公(gong)司筹备(bei)后理(li)(li)(li)应(ying)(ying)向原审核单(dan)(dan)位(wei)申(shen)(shen)请(qing)(qing)(qing)(qing)办(ban)理(li)(li)(li)工(gong)(gong)程(cheng)(cheng)(cheng)验收(shou)—原审核单(dan)(dan)位(wei)理(li)(li)(li)应(ying)(ying)自(zi)接(jie)到申(shen)(shen)请(qing)(qing)(qing)(qing)办(ban)理(li)(li)(li)30个(ge)(ge)工(gong)(gong)作中日(ri)内根据《药(yao)(yao)品(pin)(pin)管(guan)理(li)(li)(li)法(fa)》第8条:开设药(yao)(yao)物(wu)(wu)(wu)制(zhi)(zhi)造(zao)(zao)(zao)(zao)业(ye)(ye)(ye)企(qi)业(ye)(ye)(ye)务必具有(you)的(de)标(biao)准机构工(gong)(gong)程(cheng)(cheng)(cheng)验收(shou)。达(da)(da)标(biao)的(de)发(fa)送(song)给《药(yao)(yao)品(pin)(pin)生产(chan)(chan)许可证(zheng)(zheng)(zheng)(zheng)》。2、申(shen)(shen)办(ban)人(ren)凭《药(yao)(yao)品(pin)(pin)生产(chan)(chan)许可证(zheng)(zheng)(zheng)(zheng)》,到市场监(jian)(jian)(jian)(jian)督管(guan)理(li)(li)(li)管(guan)理(li)(li)(li)方法(fa)单(dan)(dan)位(wei)依法(fa)处理(li)(li)(li)注(zhu)册(ce)(ce)登记,领到《营业(ye)(ye)(ye)执照》;3、药(yao)(yao)物(wu)(wu)(wu)制(zhi)(zhi)造(zao)(zao)(zao)(zao)业(ye)(ye)(ye)企(qi)业(ye)(ye)(ye)生产(chan)(chan)制(zhi)(zhi)造(zao)(zao)(zao)(zao)药(yao)(yao)物(wu)(wu)(wu)务必经(jing)国(guo)家药(yao)(yao)品(pin)(pin)监(jian)(jian)(jian)(jian)督管(guan)理(li)(li)(li)局(ju)申(shen)(shen)请(qing)(qing)(qing)(qing)注(zhu)册(ce)(ce),发(fa)送(song)给药(yao)(yao)物(wu)(wu)(wu)生产(chan)(chan)制(zhi)(zhi)造(zao)(zao)(zao)(zao)证(zheng)(zheng)(zheng)(zheng)明(ming)材(cai)料(liao)(即(ji)药(yao)(yao)物(wu)(wu)(wu)准字号(hao))即(ji)可生产(chan)(chan)制(zhi)(zhi)造(zao)(zao)(zao)(zao)药(yao)(yao)物(wu)(wu)(wu)。申(shen)(shen)请(qing)(qing)(qing)(qing)办(ban)理(li)(li)(li)申(shen)(shen)请(qing)(qing)(qing)(qing)注(zhu)册(ce)(ce)一(yi)个(ge)(ge)药(yao)(yao)物(wu)(wu)(wu)的(de)程(cheng)(cheng)(cheng)序流程(cheng)(cheng)(cheng)比(bi)较复杂(za),这儿不可以详细描述了;4、申(shen)(shen)请(qing)(qing)(qing)(qing)办(ban)理(li)(li)(li)GMP认证(zheng)(zheng)(zheng)(zheng);《药(yao)(yao)品(pin)(pin)管(guan)理(li)(li)(li)法(fa)实(shi)施条例》第6条要求(qiu),新(xin)开设药(yao)(yao)物(wu)(wu)(wu)制(zhi)(zhi)造(zao)(zao)(zao)(zao)业(ye)(ye)(ye)企(qi)业(ye)(ye)(ye)理(li)(li)(li)应(ying)(ying)自(zi)获得药(yao)(yao)物(wu)(wu)(wu)生产(chan)(chan)制(zhi)(zhi)造(zao)(zao)(zao)(zao)证(zheng)(zheng)(zheng)(zheng)明(ming)材(cai)料(liao)或是(shi)经(jing)准许宣布生产(chan)(chan)制(zhi)(zhi)造(zao)(zao)(zao)(zao)之日(ri)起30日(ri)内明(ming)确提出(chu)(chu)验证(zheng)(zheng)(zheng)(zheng)申(shen)(shen)请(qing)(qing)(qing)(qing)办(ban)理(li)(li)(li),省之上药(yao)(yao)物(wu)(wu)(wu)监(jian)(jian)(jian)(jian)管(guan)单(dan)(dan)位(wei)理(li)(li)(li)应(ying)(ying)自(zi)接(jie)到申(shen)(shen)请(qing)(qing)(qing)(qing)办(ban)理(li)(li)(li)之日(ri)6个(ge)(ge)月(yue)内机构对开展验证(zheng)(zheng)(zheng)(zheng),验证(zheng)(zheng)(zheng)(zheng)达(da)(da)标(biao)的(de)发(fa)送(song)给GMP认证(zheng)(zheng)(zheng)(zheng)资格证(zheng)(zheng)(zheng)(zheng)书。

制药洁净(jing)厂房还必(bi)须遵循:GBJ12-87工业(ye)生产产品标(biao)(biao)准(zhun)护(hu)轨铁(tie)路线设(she)(she)计(ji)(ji)标(biao)(biao)准(zhun)、GBJ13-86户(hu)外给(ji)(ji)排水(shui)设(she)(she)计(ji)(ji)标(biao)(biao)准(zhun)(97年(nian)修(xiu)定(ding))、GB50013-2006户(hu)外给(ji)(ji)排水(shui)设(she)(she)计(ji)(ji)标(biao)(biao)准(zhun)、GBJ14-87室(shi)(shi)外排水(shui)管(guan)设(she)(she)计(ji)(ji)标(biao)(biao)准(zhun)(97年(nian)修(xiu)定(ding))、GB50014-2006室(shi)(shi)外排水(shui)管(guan)设(she)(she)计(ji)(ji)标(biao)(biao)准(zhun)、GB50015-2003工程建(jian)筑(zhu)建(jian)筑(zhu)给(ji)(ji)排水(shui)设(she)(she)计(ji)(ji)标(biao)(biao)准(zhun)、GBJ16-87建(jian)筑(zhu)规划(hua)设(she)(she)计(ji)(ji)消防(fang)规范(2001年(nian)修(xiu)订(ding)本)等要求。


以上就是J9九游会AG环境工程为(wei)大(da)家(jia)带来的“制药洁净(jing)厂房建(jian)设(she)法规”,希望能对您有所帮助。可以看到由于种类特殊(shu),所以需要(yao)满足的条件非(fei)常多,这(zhei)点J9九游会AG 需要(yao)注意。

本文由“净化车间”装修施工公司-深圳市J9九游会AG环境工程有限公司整理发布,如需转载请注意来源及出处,原文地址:http://goodbyehatsdesign.com/cfzx/802.html


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制药洁净厂房建设的法规有哪些?

制(zhi)药洁净(jing)厂房(fang)近年来建设(she)得非常多,主(zhu)要(yao)(yao)是(shi)由于行业(ye)的(de)持续(xu)扩展,而行业(ye)要(yao)(yao)求又(you)比较严格,所以导致这(zhei)种(zhong)(zhong)结(jie)果,那么J9九游会AG 在建设(she)这(zhei)种(zhong)(zhong)厂房(fang)需(xu)要(yao)(yao)遵守的(de)法(fa)规有(you)哪些(xie)?下(xia)面J9九游会AG为大家详细介绍。

制药(yao)洁净厂房建设(she)法(fa)(fa)规(gui):《药(yao)品(pin)微(wei)生物实验(yan)室(shi)规(gui)范指(zhi)导(dao)原则》——《药(yao)典2010》—附(fu)则XIXQ。1、药(yao)品(pin)管理法(fa)(fa)。2、药(yao)品(pin)法(fa)(fa)条例全(quan)文(wen)。3、2010版GMP。4、认(ren)证(zheng)具体指(zhi)导(dao)标(biao)准2003。5、已(yi)发(fa)售中(zhong)(zhong)药(yao)材变(bian)动科学研(yan)究具体指(zhi)导(dao)标(biao)准。6、已(yi)发(fa)售中(zhong)(zhong)药(yao)注射(she)剂(ji)变(bian)动科学研(yan)究具体指(zhi)导(dao)标(biao)准。7、中(zhong)(zhong)药(yao)材申请注册方法(fa)(fa)。8、药(yao)用辅料管理条例。

制(zhi)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)洁净(jing)厂房建设规定:必须申(shen)请(qing)(qing)(qing)办(ban)(ban)理(li)(li)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)物(wu)(wu)(wu)(wu)(wu)生(sheng)产(chan)许(xu)(xu)可(ke)、企业(ye)(ye)(ye)营业(ye)(ye)(ye)执(zhi)(zhi)照、机构组织(zhi)代码、国税(shui)局(ju)、地税(shui)局(ju)、特(te)制(zhi)工艺流(liu)程GMP证(zheng)(zheng)(zheng)(zheng)(zheng)。1、开(kai)设药(yao)(yao)(yao)(yao)(yao)(yao)(yao)物(wu)(wu)(wu)(wu)(wu)制(zhi)造(zao)(zao)(zao)(zao)业(ye)(ye)(ye)企业(ye)(ye)(ye)申(shen)办(ban)(ban)人理(li)(li)应(ying)(ying)向所在(zai)城市省(sheng)部(bu)(bu)级药(yao)(yao)(yao)(yao)(yao)(yao)(yao)物(wu)(wu)(wu)(wu)(wu)监管(guan)单(dan)位(wei)(wei)申(shen)请(qing)(qing)(qing)办(ban)(ban)理(li)(li)筹备(bei);省(sheng)部(bu)(bu)级药(yao)(yao)(yao)(yao)(yao)(yao)(yao)品(pin)监督(du)管(guan)理(li)(li)单(dan)位(wei)(wei)自接到(dao)申(shen)请(qing)(qing)(qing)办(ban)(ban)理(li)(li)30个(ge)(ge)工作中日(ri)(ri)(ri)内(nei)做出是不(bu)是愿意筹备(bei)的决(jue)策—申(shen)请(qing)(qing)(qing)者进行公司(si)筹备(bei)后理(li)(li)应(ying)(ying)向原审核(he)单(dan)位(wei)(wei)申(shen)请(qing)(qing)(qing)办(ban)(ban)理(li)(li)工程验(yan)收—原审核(he)单(dan)位(wei)(wei)理(li)(li)应(ying)(ying)自接到(dao)申(shen)请(qing)(qing)(qing)办(ban)(ban)理(li)(li)30个(ge)(ge)工作中日(ri)(ri)(ri)内(nei)根(gen)据《药(yao)(yao)(yao)(yao)(yao)(yao)(yao)品(pin)管(guan)理(li)(li)法(fa)》第8条:开(kai)设药(yao)(yao)(yao)(yao)(yao)(yao)(yao)物(wu)(wu)(wu)(wu)(wu)制(zhi)造(zao)(zao)(zao)(zao)业(ye)(ye)(ye)企业(ye)(ye)(ye)务必具有的标(biao)准(zhun)机构工程验(yan)收。达标(biao)的发送给(ji)《药(yao)(yao)(yao)(yao)(yao)(yao)(yao)品(pin)生(sheng)产(chan)许(xu)(xu)可(ke)证(zheng)(zheng)(zheng)(zheng)(zheng)》。2、申(shen)办(ban)(ban)人凭《药(yao)(yao)(yao)(yao)(yao)(yao)(yao)品(pin)生(sheng)产(chan)许(xu)(xu)可(ke)证(zheng)(zheng)(zheng)(zheng)(zheng)》,到(dao)市场监督(du)管(guan)理(li)(li)管(guan)理(li)(li)方法(fa)单(dan)位(wei)(wei)依法(fa)处理(li)(li)注册(ce)登(deng)记,领(ling)到(dao)《营业(ye)(ye)(ye)执(zhi)(zhi)照》;3、药(yao)(yao)(yao)(yao)(yao)(yao)(yao)物(wu)(wu)(wu)(wu)(wu)制(zhi)造(zao)(zao)(zao)(zao)业(ye)(ye)(ye)企业(ye)(ye)(ye)生(sheng)产(chan)制(zhi)造(zao)(zao)(zao)(zao)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)物(wu)(wu)(wu)(wu)(wu)务必经国家药(yao)(yao)(yao)(yao)(yao)(yao)(yao)品(pin)监督(du)管(guan)理(li)(li)局(ju)申(shen)请(qing)(qing)(qing)注册(ce),发送给(ji)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)物(wu)(wu)(wu)(wu)(wu)生(sheng)产(chan)制(zhi)造(zao)(zao)(zao)(zao)证(zheng)(zheng)(zheng)(zheng)(zheng)明(ming)材料(即药(yao)(yao)(yao)(yao)(yao)(yao)(yao)物(wu)(wu)(wu)(wu)(wu)准(zhun)字(zi)号(hao))即可(ke)生(sheng)产(chan)制(zhi)造(zao)(zao)(zao)(zao)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)物(wu)(wu)(wu)(wu)(wu)。申(shen)请(qing)(qing)(qing)办(ban)(ban)理(li)(li)申(shen)请(qing)(qing)(qing)注册(ce)一个(ge)(ge)药(yao)(yao)(yao)(yao)(yao)(yao)(yao)物(wu)(wu)(wu)(wu)(wu)的程序流(liu)程比较复杂,这(zhei)儿(er)不(bu)可(ke)以详(xiang)细描述了;4、申(shen)请(qing)(qing)(qing)办(ban)(ban)理(li)(li)GMP认证(zheng)(zheng)(zheng)(zheng)(zheng);《药(yao)(yao)(yao)(yao)(yao)(yao)(yao)品(pin)管(guan)理(li)(li)法(fa)实施条例(li)》第6条要(yao)求,新(xin)开(kai)设药(yao)(yao)(yao)(yao)(yao)(yao)(yao)物(wu)(wu)(wu)(wu)(wu)制(zhi)造(zao)(zao)(zao)(zao)业(ye)(ye)(ye)企业(ye)(ye)(ye)理(li)(li)应(ying)(ying)自获得药(yao)(yao)(yao)(yao)(yao)(yao)(yao)物(wu)(wu)(wu)(wu)(wu)生(sheng)产(chan)制(zhi)造(zao)(zao)(zao)(zao)证(zheng)(zheng)(zheng)(zheng)(zheng)明(ming)材料或(huo)是经准(zhun)许(xu)(xu)宣布生(sheng)产(chan)制(zhi)造(zao)(zao)(zao)(zao)之(zhi)日(ri)(ri)(ri)起30日(ri)(ri)(ri)内(nei)明(ming)确(que)提出验(yan)证(zheng)(zheng)(zheng)(zheng)(zheng)申(shen)请(qing)(qing)(qing)办(ban)(ban)理(li)(li),省(sheng)之(zhi)上药(yao)(yao)(yao)(yao)(yao)(yao)(yao)物(wu)(wu)(wu)(wu)(wu)监管(guan)单(dan)位(wei)(wei)理(li)(li)应(ying)(ying)自接到(dao)申(shen)请(qing)(qing)(qing)办(ban)(ban)理(li)(li)之(zhi)日(ri)(ri)(ri)6个(ge)(ge)月内(nei)机构对(dui)开(kai)展验(yan)证(zheng)(zheng)(zheng)(zheng)(zheng),验(yan)证(zheng)(zheng)(zheng)(zheng)(zheng)达标(biao)的发送给(ji)GMP认证(zheng)(zheng)(zheng)(zheng)(zheng)资格证(zheng)(zheng)(zheng)(zheng)(zheng)书。

制药洁净厂房还必须(xu)遵循(xun):GBJ12-87工业生产(chan)产(chan)品标(biao)准(zhun)(zhun)护轨铁路线设(she)(she)计(ji)标(biao)准(zhun)(zhun)、GBJ13-86户外(wai)给排(pai)水(shui)(shui)(shui)设(she)(she)计(ji)标(biao)准(zhun)(zhun)(97年(nian)(nian)修(xiu)定)、GB50013-2006户外(wai)给排(pai)水(shui)(shui)(shui)设(she)(she)计(ji)标(biao)准(zhun)(zhun)、GBJ14-87室外(wai)排(pai)水(shui)(shui)(shui)管(guan)设(she)(she)计(ji)标(biao)准(zhun)(zhun)(97年(nian)(nian)修(xiu)定)、GB50014-2006室外(wai)排(pai)水(shui)(shui)(shui)管(guan)设(she)(she)计(ji)标(biao)准(zhun)(zhun)、GB50015-2003工程建(jian)(jian)筑建(jian)(jian)筑给排(pai)水(shui)(shui)(shui)设(she)(she)计(ji)标(biao)准(zhun)(zhun)、GBJ16-87建(jian)(jian)筑规划设(she)(she)计(ji)消防规范(2001年(nian)(nian)修(xiu)订本)等(deng)要求。


以(yi)上就是J9九游会AG环境工(gong)程为大家带来的“制药洁净(jing)厂房建(jian)设法规”,希望能对您有所帮助。可以(yi)看到(dao)由于种类特殊,所以(yi)需要满足的条件非常多,这点J9九游会AG 需要注意。


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