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廠房是否有潔凈要求？詳細規范！

來源：hardcandy99.cn 發布時間：2023/10/24 17:09:58
  新版本《GMP》對(dui)潔(jie)凈廠(chang)房(fang)(fang)下列幾層面(mian)開(kai)展(zhan)了(le)論述：1通(tong)則；兩(liang)人員；3廠(chang)房(fang)(fang)；4機器設(she)備；5環境衛(wei)生(sheng)(sheng)(sheng)；6原材料、輔(fu)材及包(bao)裝制(zhi)(zhi)(zhi)(zhi)品(pin)；7企(qi)業生(sheng)(sheng)(sheng)產(chan)(chan)管(guan)理；8包(bao)裝和(he)(he)貼簽；9企(qi)業生(sheng)(sheng)(sheng)產(chan)(chan)管(guan)理和(he)(he)質量控(kong)制(zhi)(zhi)(zhi)(zhi)；10文檔質量控(kong)制(zhi)(zhi)(zhi)(zhi)單位；11自查(cha)；12市場銷售紀錄；13用戶反饋和(he)(he)副作用匯報；14附(fu)則。最新政策參考世衛(wei)組織(zhi)和(he)(he)比較發達GMP的(de)(de)要求(qiu)(qiu)，要求(qiu)(qiu)了(le)藥(yao)(yao)(yao)(yao)(yao)物生(sheng)(sheng)(sheng)產(chan)(chan)制(zhi)(zhi)(zhi)(zhi)造(zao)(zao)(zao)廠(chang)房(fang)(fang)的(de)(de)潔(jie)凈度等級和(he)(he)適(shi)用藥(yao)(yao)(yao)(yao)(yao)物生(sheng)(sheng)(sheng)產(chan)(chan)制(zhi)(zhi)(zhi)(zhi)造(zao)(zao)(zao)的(de)(de)類型和(he)(he)工藝流程；對(dui)中(zhong)(zhong)(zhong)草藥(yao)(yao)(yao)(yao)(yao)材的(de)(de)前(qian)解(jie)決(jue)、獲取、濃縮(suo)及小動物內(nei)臟器官、機構的(de)(de)清洗或解(jie)決(jue)的(de)(de)廠(chang)房(fang)(fang)和(he)(he)相(xiang)關(guan)生(sheng)(sheng)(sheng)產(chan)(chan)制(zhi)(zhi)(zhi)(zhi)造(zao)(zao)(zao)實際操作要求(qiu)(qiu)做出了(le)要求(qiu)(qiu)，對(dui)中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)(yao)(yao)方劑生(sheng)(sheng)(sheng)產(chan)(chan)制(zhi)(zhi)(zhi)(zhi)造(zao)(zao)(zao)的(de)(de)事(shi)后工藝流程——中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)(yao)(yao)制(zhi)(zhi)(zhi)(zhi)劑生(sheng)(sheng)(sheng)產(chan)(chan)制(zhi)(zhi)(zhi)(zhi)造(zao)(zao)(zao)，在(zai)GMP層面(mian)的(de)(de)要求(qiu)(qiu)與(yu)化學(xue)品(pin)的(de)(de)中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)(yao)(yao)制(zhi)(zhi)(zhi)(zhi)劑生(sheng)(sheng)(sheng)產(chan)(chan)制(zhi)(zhi)(zhi)(zhi)造(zao)(zao)(zao)應(ying)同樣(yang)；對(dui)藥(yao)(yao)(yao)(yao)(yao)物包(bao)裝材料也納(na)入(ru)了(le)GMP的(de)(de)生(sheng)(sheng)(sheng)產(chan)(chan)制(zhi)(zhi)(zhi)(zhi)造(zao)(zao)(zao)操縱圍；生(sheng)(sheng)(sheng)物制(zhi)(zhi)(zhi)(zhi)藥(yao)(yao)(yao)(yao)(yao)的(de)(de)廠(chang)房(fang)(fang)、生(sheng)(sheng)(sheng)產(chan)(chan)加(jia)工和(he)(he)罐裝有其獨特的(de)(de)要求(qiu)(qiu)，因而也依據生(sheng)(sheng)(sheng)物制(zhi)(zhi)(zhi)(zhi)藥(yao)(yao)(yao)(yao)(yao)生(sheng)(sheng)(sheng)產(chan)(chan)制(zhi)(zhi)(zhi)(zhi)造(zao)(zao)(zao)特性制(zhi)(zhi)(zhi)(zhi)定(ding)了(le)相(xiang)對(dui)應(ying)的(de)(de)條文，新修訂的(de)(de)《規(gui)》不但適(shi)用化學(xue)品(pin)和(he)(he)抗生(sheng)(sheng)(sheng)素藥(yao)(yao)(yao)(yao)(yao)品(pin)的(de)(de)原材料和(he)(he)中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)(yao)(yao)制(zhi)(zhi)(zhi)(zhi)劑，也適(shi)用中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)(yao)(yao)材和(he)(he)中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)(yao)(yao)材切成片(pian)加(jia)式、生(sheng)(sheng)(sheng)物制(zhi)(zhi)(zhi)(zhi)藥(yao)(yao)(yao)(yao)(yao)和(he)(he)血(xue)制(zhi)(zhi)(zhi)(zhi)品(pin)的(de)(de)生(sheng)(sheng)(sheng)產(chan)(chan)制(zhi)(zhi)(zhi)(zhi)造(zao)(zao)(zao)和(he)(he)質量控(kong)制(zhi)(zhi)(zhi)(zhi)。
  潔(jie)凈廠房要合(he)乎下邊要求：一(yi)、潔(jie)凈廠房的(de)(de)(de)工(gong)(gong)程(cheng)建筑平面(mian)圖(tu)和(he)總體(ti)(ti)布局應(ying)(ying)具(ju)(ju)備適(shi)度(du)的(de)(de)(de)協調(diao)能力(li)。主體(ti)(ti)工(gong)(gong)程(cheng)宜(yi)選(xuan)(xuan)用(yong)大容量及(ji)大跨距(ju)柱距(ju)，不適(shi)合(he)選(xuan)(xuan)用(yong)內外墻(qiang)載重管(guan)理體(ti)(ti)系。二、潔(jie)凈廠房排架結(jie)構(gou)的(de)(de)(de)原材料(liao)型號選(xuan)(xuan)擇應(ying)(ying)合(he)乎隔(ge)熱保溫(wen)、隔(ge)熱保溫(wen)、防(fang)(fang)火安(an)全(quan)、防(fang)(fang)水、少產塵(chen)等(deng)要求。三、潔(jie)凈廠房主體(ti)(ti)工(gong)(gong)程(cheng)的(de)(de)(de)使用(yong)性(xing)能應(ying)(ying)與房間內武器裝備和(he)室(shi)內裝修水準相融(rong)洽，并應(ying)(ying)具(ju)(ju)備防(fang)(fang)火安(an)全(quan)、操縱溫(wen)度(du)形(xing)變(bian)和(he)不勻稱地面(mian)沉降特性(xing)。廠房建筑變(bian)形(xing)縫(feng)不適(shi)合(he)穿越(yue)重生潔(jie)凈區。四、送、回通風風管(guan)和(he)別的(de)(de)(de)管(guan)道(dao)(dao)暗敷時(shi)(shi)，應(ying)(ying)設定(ding)技術性(xing)隔(ge)層、技術性(xing)夾道(dao)(dao)或管(guan)溝等(deng)。穿越(yue)重生樓房的(de)(de)(de)縱向管(guan)道(dao)(dao)需(xu)暗敷時(shi)(shi)，宜(yi)設定(ding)技術性(xing)立井，其方式、規(gui)格和(he)結(jie)構(gou)應(ying)(ying)合(he)乎風管(guan)、管(guan)道(dao)(dao)的(de)(de)(de)安(an)裝、維修和(he)防(fang)(fang)火安(an)全(quan)要求。五、對(dui)兼具(ju)(ju)一(yi)般(ban)生產制(zhi)(zhi)(zhi)造和(he)潔(jie)凈生產制(zhi)(zhi)(zhi)造的(de)(de)(de)綜合(he)型廠房的(de)(de)(de)平面(mian)布局和(he)結(jie)構(gou)解決，應(ying)(ying)防(fang)(fang)止(zhi)人(ren)工(gong)(gong)流產、運輸物流及(ji)防(fang)(fang)火安(an)全(quan)層面(mian)對(dui)潔(jie)凈生產制(zhi)(zhi)(zhi)造帶來不利的(de)(de)(de)危害。

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