質量管理(li)體系

公(gong)(gong)司擁(yong)有完整(zheng)健全(quan)(quan)(quan)的藥品質(zhi)(zhi)(zhi)量(liang)(liang)(liang)(liang)管(guan)理體系，質(zhi)(zhi)(zhi)量(liang)(liang)(liang)(liang)控(kong)制涵蓋原輔材料(liao)、包裝材料(liao)、生產(chan)、放行、存(cun)儲、銷售、市場質(zhi)(zhi)(zhi)量(liang)(liang)(liang)(liang)反饋(kui)等(deng)(deng)全(quan)(quan)(quan)過(guo)程。從質(zhi)(zhi)(zhi)量(liang)(liang)(liang)(liang)目(mu)標(biao)、質(zhi)(zhi)(zhi)量(liang)(liang)(liang)(liang)方(fang)針、質(zhi)(zhi)(zhi)量(liang)(liang)(liang)(liang)管(guan)理體系文(wen)件及(ji)企(qi)業(ye)負(fu)責(ze)(ze)(ze)人(ren)職(zhi)責(ze)(ze)(ze)、生產(chan)管(guan)理負(fu)責(ze)(ze)(ze)人(ren)職(zhi)責(ze)(ze)(ze)、質(zhi)(zhi)(zhi)量(liang)(liang)(liang)(liang)管(guan)理負(fu)責(ze)(ze)(ze)人(ren)職(zhi)責(ze)(ze)(ze)、質(zhi)(zhi)(zhi)量(liang)(liang)(liang)(liang)受權人(ren)職(zhi)責(ze)(ze)(ze)、質(zhi)(zhi)(zhi)量(liang)(liang)(liang)(liang)保證部門職(zhi)責(ze)(ze)(ze)、質(zhi)(zhi)(zhi)量(liang)(liang)(liang)(liang)風(feng)險管(guan)理規程等(deng)(deng)全(quan)(quan)(quan)過(guo)程入手，對公(gong)(gong)司全(quan)(quan)(quan)體員工進(jin)行系統全(quan)(quan)(quan)面的GMP規范、質(zhi)(zhi)(zhi)量(liang)(liang)(liang)(liang)方(fang)針、法(fa)規、文(wen)件、專(zhuan)業(ye)知識以及(ji)實(shi)際(ji)操作(zuo)等(deng)(deng)的學(xue)習培訓(xun)，考核合格后上崗工作(zuo)。公(gong)(gong)司定期開展驗(yan)證工作(zuo)，保持持續驗(yan)證狀(zhuang)態，有效保證質(zhi)(zhi)(zhi)量(liang)(liang)(liang)(liang)管(guan)理體系的運行和改進(jin)。

公(gong)司根據《藥品生產質(zhi)量(liang)管理(li)規(gui)范》（2010年(nian)修訂(ding)）建立了較為全面的(de)文件體系，涵蓋質(zhi)量(liang)管理(li)、機(ji)構與(yu)(yu)(yu)(yu)人員、廠房與(yu)(yu)(yu)(yu)設施、物料與(yu)(yu)(yu)(yu)產品、確認與(yu)(yu)(yu)(yu)驗證、文件管理(li)、生產管理(li)、質(zhi)量(liang)控制(zhi)與(yu)(yu)(yu)(yu)質(zhi)量(liang)保證、委(wei)托生產與(yu)(yu)(yu)(yu)委(wei)托檢驗、產品發(fa)運與(yu)(yu)(yu)(yu)召(zhao)回、自檢等(deng)方面的(de)文件體系。

質量控制

公司設檢驗室行(xing)使質量(liang)控制(zhi)職(zhi)能，并(bing)獨立于生產管理(li)部門，負責產品全過程(cheng)(cheng)的質量(liang)管理(li)和(he)監(jian)督。質量(liang)管理(li)部共有人員15名，包含質量(liang)保證（QA）4名，質量(liang)控制(zhi)（QC）11名,其中(zhong)高級工(gong)(gong)程(cheng)(cheng)師1名，中(zhong)級工(gong)(gong)程(cheng)(cheng)師5名，助理(li)工(gong)(gong)程(cheng)(cheng)師7名。

質量管理(li)部檢(jian)驗(yan)中心面積約(yue)1420m2，理(li)化(hua)檢(jian)驗(yan)區約(yue)770m2，微(wei)生物(wu)(wu)檢(jian)驗(yan)區約(yue)650m2。理(li)化(hua)檢(jian)驗(yan)區主要(yao)功(gong)能間(jian)為(wei)普(pu)(pu)通儀器(qi)室(shi)(shi)(shi)(shi)、理(li)化(hua)檢(jian)驗(yan)室(shi)(shi)(shi)(shi)、精(jing)密儀器(qi)室(shi)(shi)(shi)(shi)、高溫(wen)室(shi)(shi)(shi)(shi)、普(pu)(pu)通試(shi)劑室(shi)(shi)(shi)(shi)、毒性試(shi)劑室(shi)(shi)(shi)(shi)、玻璃儀器(qi)室(shi)(shi)(shi)(shi)等(deng)主要(yao)功(gong)能間(jian)；微(wei)生物(wu)(wu)檢(jian)驗(yan)區主要(yao)功(gong)能間(jian)為(wei)微(wei)生物(wu)(wu)檢(jian)驗(yan)室(shi)(shi)(shi)(shi)、陽性檢(jian)驗(yan)室(shi)(shi)(shi)(shi)、微(wei)生物(wu)(wu)準備室(shi)(shi)(shi)(shi)、成品(pin)留(liu)(liu)樣室(shi)(shi)(shi)(shi)、陰涼留(liu)(liu)樣室(shi)(shi)(shi)(shi)、標本室(shi)(shi)(shi)(shi)、穩(wen)定性考察(cha)室(shi)(shi)(shi)(shi)等(deng)主要(yao)功(gong)能間(jian)。

質量檢驗實(shi)驗室

質(zhi)量(liang)檢(jian)驗(yan)人員均參加相關檢(jian)驗(yan)技能(neng)培訓，能(neng)夠獨立完成(cheng)各(ge)項檢(jian)驗(yan)操(cao)作，制(zhi)訂(ding)了(le)取樣、留樣、穩定性考察(cha)和產品放行(xing)等相關的質(zhi)量(liang)控制(zhi)文(wen)件，并(bing)按(an)照文(wen)件要(yao)求開(kai)展質(zhi)量(liang)控制(zhi)活(huo)動。

質量管(guan)理部(bu)(bu)質檢中心(xin)配備(bei)元(yuan)胡索乙(yi)素、人(ren)參(can)皂(zao)(zao)苷Rg、丹參(can)酮IIA丹酚酸B、三七皂(zao)(zao)苷R1等55余種用于檢驗(yan)(yan)生產(chan)品(pin)種所需的(de)國(guo)家標準(zhun)物(wu)質，配備(bei)《中國(guo)藥典》2015年版（一部(bu)(bu)、二部(bu)(bu)、四(si)部(bu)(bu)）和(he)《甘(gan)(gan)肅(su)省中藥材(cai)(cai)標準(zhun)》(2009年版)。質檢中心(xin)配有(you)(you)(you)檢測(ce)(ce)(ce)儀(yi)器共96臺(tai)（套），并(bing)定(ding)期校(xiao)驗(yan)(yan)，基本(ben)滿足(zu)檢測(ce)(ce)(ce)要求(qiu)。關(guan)(guan)鍵檢驗(yan)(yan)設(she)(she)備(bei)包括(kuo)：SCL-10A島(dao)津高(gao)效液(ye)相色(se)譜(pu)(pu)(pu)儀(yi)、Agilant1260高(gao)效液(ye)相色(se)譜(pu)(pu)(pu)儀(yi)、Agilant Cary630 FTIR光(guang)(guang)譜(pu)(pu)(pu)儀(yi)、Agilant1260-2高(gao)效液(ye)相色(se)譜(pu)(pu)(pu)儀(yi)、Ice3000原(yuan)子吸收光(guang)(guang)譜(pu)(pu)(pu)儀(yi)、AX204電子天(tian)平、MS電子天(tian)平、TU1901紫(zi)外可(ke)見分(fen)光(guang)(guang)光(guang)(guang)度(du)計(ji)、CS-9301PC島(dao)津薄層(ceng)色(se)譜(pu)(pu)(pu)掃描儀(yi)、ZB1C崩解(jie)時(shi)限測(ce)(ce)(ce)定(ding)儀(yi)、WD-9403A紫(zi)外分(fen)析儀(yi)、PHS-25酸度(du)計(ji)等。質檢中心(xin)微生物(wu)限度(du)檢測(ce)(ce)(ce)設(she)(she)有(you)(you)(you)微生物(wu)檢測(ce)(ce)(ce)室(shi)、陽(yang)性對照室(shi)、生物(wu)檢定(ding)室(shi)（陽(yang)性菌種來(lai)源于甘(gan)(gan)肅(su)省藥品(pin)檢驗(yan)(yan)研究院），并(bing)設(she)(she)置(zhi)了獨立(li)的(de)空(kong)調控制系統。質檢中心(xin)根據相關(guan)(guan)要求(qiu)建立(li)了原(yuan)藥材(cai)(cai)正(zheng)品(pin)標本(ben)室(shi)，有(you)(you)(you)溫濕(shi)度(du)監測(ce)(ce)(ce)裝置(zhi)，由專人(ren)管(guan)理，有(you)(you)(you)各種管(guan)理制度(du)和(he)記(ji)錄，公司共有(you)(you)(you)77個正(zheng)品(pin)（偽品(pin)）原(yuan)藥材(cai)(cai)及(ji)飲片(pian)標本(ben)。

質量(liang)檢驗設備

質(zhi)量保(bao)證

公(gong)司設質(zhi)量(liang)管(guan)理(li)部行(xing)(xing)使(shi)質(zhi)量(liang)保證(zheng)職能，建立了(le)生產(chan)過程質(zhi)量(liang)現場監控、變更控制、偏差(cha)處(chu)理(li)、糾(jiu)正措施和預防(fang)措施（CAPA）、不合格物(wu)料處(chu)理(li)和產(chan)品質(zhi)量(liang)回顧管(guan)理(li)制度(du)(du)，并依據制度(du)(du)進(jin)行(xing)(xing)了(le)變更控制、偏差(cha)、OOS處(chu)理(li)工作；根據物(wu)料屬性和對所生產(chan)藥品質(zhi)量(liang)影響情況，對物(wu)料供應商進(jin)行(xing)(xing)評估和管(guan)理(li)；建立有成品放(fang)行(xing)(xing)審核管(guan)理(li)制度(du)(du)，由質(zhi)量(liang)受權人對產(chan)品進(jin)行(xing)(xing)放(fang)行(xing)(xing)。

質(zhi)(zhi)量(liang)(liang)(liang)(liang)管(guan)(guan)(guan)理(li)(li)(li)(li)部根(gen)(gen)據(ju)(ju)《生(sheng)(sheng)(sheng)(sheng)產(chan)(chan)(chan)(chan)(chan)(chan)過程(cheng)(cheng)(cheng)質(zhi)(zhi)量(liang)(liang)(liang)(liang)監(jian)(jian)控(kong)管(guan)(guan)(guan)理(li)(li)(li)(li)規(gui)程(cheng)(cheng)(cheng)》，由(you)QA根(gen)(gen)據(ju)(ju)各(ge)產(chan)(chan)(chan)(chan)(chan)(chan)品(pin)的(de)工藝要(yao)求和質(zhi)(zhi)量(liang)(liang)(liang)(liang)標準，對(dui)(dui)在(zai)線生(sheng)(sheng)(sheng)(sheng)產(chan)(chan)(chan)(chan)(chan)(chan)產(chan)(chan)(chan)(chan)(chan)(chan)品(pin)進(jin)(jin)行(xing)監(jian)(jian)督(du)檢(jian)(jian)查，監(jian)(jian)督(du)檢(jian)(jian)查和抽查依據(ju)(ju)各(ge)劑型質(zhi)(zhi)量(liang)(liang)(liang)(liang)監(jian)(jian)控(kong)點要(yao)求開展(zhan)，監(jian)(jian)控(kong)過程(cheng)(cheng)(cheng)中對(dui)(dui)生(sheng)(sheng)(sheng)(sheng)產(chan)(chan)(chan)(chan)(chan)(chan)現(xian)場(chang)工序(xu)、記(ji)錄及(ji)(ji)時檢(jian)(jian)查，確保藥品(pin)在(zai)各(ge)個生(sheng)(sheng)(sheng)(sheng)產(chan)(chan)(chan)(chan)(chan)(chan)環節(jie)的(de)質(zhi)(zhi)量(liang)(liang)(liang)(liang)得到嚴(yan)格(ge)控(kong)制(zhi)(zhi)，以生(sheng)(sheng)(sheng)(sheng)產(chan)(chan)(chan)(chan)(chan)(chan)出合格(ge)的(de)藥品(pin)。根(gen)(gen)據(ju)(ju)《產(chan)(chan)(chan)(chan)(chan)(chan)品(pin)年度(du)質(zhi)(zhi)量(liang)(liang)(liang)(liang)回(hui)顧分(fen)(fen)析(xi)管(guan)(guan)(guan)理(li)(li)(li)(li)規(gui)程(cheng)(cheng)(cheng)》對(dui)(dui)產(chan)(chan)(chan)(chan)(chan)(chan)品(pin)每年進(jin)(jin)行(xing)質(zhi)(zhi)量(liang)(liang)(liang)(liang)回(hui)顧，有質(zhi)(zhi)量(liang)(liang)(liang)(liang)分(fen)(fen)析(xi)報(bao)告，內(nei)容涵蓋生(sheng)(sheng)(sheng)(sheng)產(chan)(chan)(chan)(chan)(chan)(chan)工藝、質(zhi)(zhi)量(liang)(liang)(liang)(liang)規(gui)范(fan)、技(ji)術(shu)標準、人員(yuan)培訓、制(zhi)(zhi)水、空調(diao)、原輔料購進(jin)(jin)及(ji)(ji)生(sheng)(sheng)(sheng)(sheng)產(chan)(chan)(chan)(chan)(chan)(chan)管(guan)(guan)(guan)理(li)(li)(li)(li)等(deng)方面內(nei)容。按相關要(yao)求建立(li)了(le)不(bu)(bu)良(liang)反(fan)應(ying)監(jian)(jian)測控(kong)制(zhi)(zhi)管(guan)(guan)(guan)理(li)(li)(li)(li)程(cheng)(cheng)(cheng)序(xu)，并(bing)對(dui)(dui)發現(xian)的(de)產(chan)(chan)(chan)(chan)(chan)(chan)品(pin)不(bu)(bu)良(liang)反(fan)應(ying)按照(zhao)相關程(cheng)(cheng)(cheng)序(xu)報(bao)告。根(gen)(gen)據(ju)(ju)《藥品(pin)質(zhi)(zhi)量(liang)(liang)(liang)(liang)風(feng)險(xian)(xian)管(guan)(guan)(guan)理(li)(li)(li)(li)規(gui)程(cheng)(cheng)(cheng)》，完善企(qi)業(ye)質(zhi)(zhi)量(liang)(liang)(liang)(liang)風(feng)險(xian)(xian)管(guan)(guan)(guan)理(li)(li)(li)(li)文件，規(gui)定(ding)對(dui)(dui)工藝驗證(zheng)、設(she)備驗證(zheng)、廠房設(she)施(shi)(shi)、偏差處理(li)(li)(li)(li)、物料供應(ying)商(shang)審計(ji)等(deng)開展(zhan)風(feng)險(xian)(xian)評估，質(zhi)(zhi)量(liang)(liang)(liang)(liang)風(feng)險(xian)(xian)管(guan)(guan)(guan)理(li)(li)(li)(li)制(zhi)(zhi)度(du)貫穿于生(sheng)(sheng)(sheng)(sheng)產(chan)(chan)(chan)(chan)(chan)(chan)全過程(cheng)(cheng)(cheng)。根(gen)(gen)據(ju)(ju)《公(gong)司(si)GMP自(zi)(zi)(zi)檢(jian)(jian)管(guan)(guan)(guan)理(li)(li)(li)(li)規(gui)程(cheng)(cheng)(cheng)》，定(ding)期開展(zhan)自(zi)(zi)(zi)檢(jian)(jian)，自(zi)(zi)(zi)檢(jian)(jian)記(ji)錄包括(kuo)缺陷項目、綜(zong)合評價及(ji)(ji)建議(yi)等(deng)，并(bing)對(dui)(dui)整改情況進(jin)(jin)行(xing)跟蹤確認，質(zhi)(zhi)量(liang)(liang)(liang)(liang)部門(men)經過偏差處理(li)(li)(li)(li)、風(feng)險(xian)(xian)分(fen)(fen)析(xi)，制(zhi)(zhi)定(ding)整改計(ji)劃和糾正預防措(cuo)施(shi)(shi)，逐(zhu)項落實整改，形成企(qi)業(ye)自(zi)(zi)(zi)檢(jian)(jian)報(bao)告。