檢(jian)(jian)(jian)(jian)(jian)驗(yan)(yan)檢(jian)(jian)(jian)(jian)(jian)測機(ji)(ji)(ji)構(gou)資(zi)(zi)質(zhi)(zhi)認(ren)(ren)定(ding)（CMA）由省級(ji)市(shi)(shi)場(chang)監督(du)管理局認(ren)(ren)定(ding)。在國(guo)家(jia)市(shi)(shi)場(chang)監督(du)管理總局尚未頒布(bu)需要(yao)CMA資(zi)(zi)質(zhi)(zhi)認(ren)(ren)定(ding)的(de)(de)范圍(wei)清單(dan)前，從事為藥(yao)品(pin)/生物制品(pin)企業(ye)、醫療機(ji)(ji)(ji)構(gou)提供細胞檢(jian)(jian)(jian)(jian)(jian)定(ding)的(de)(de)檢(jian)(jian)(jian)(jian)(jian)測機(ji)(ji)(ji)構(gou)是否(fou)需要(yao)CMA資(zi)(zi)質(zhi)(zhi)認(ren)(ren)定(ding)一直(zhi)有(you)不同說法(fa)。但(dan)像中檢(jian)(jian)(jian)(jian)(jian)院這(zhe)樣(yang)的(de)(de)國(guo)家(jia)權威檢(jian)(jian)(jian)(jian)(jian)測機(ji)(ji)(ji)構(gou)，一直(zhi)持有(you)CMA認(ren)(ren)證(zheng)(zheng)(zheng)(zheng)(zheng)證(zheng)(zheng)(zheng)(zheng)(zheng)書(shu)。根據相關CMA證(zheng)(zheng)(zheng)(zheng)(zheng)書(shu)記載，CMA證(zheng)(zheng)(zheng)(zheng)(zheng)書(shu)證(zheng)(zheng)(zheng)(zheng)(zheng)明(ming)有(you)證(zheng)(zheng)(zheng)(zheng)(zheng)機(ji)(ji)(ji)構(gou)具備(bei)國(guo)家(jia)有(you)關法(fa)律、行政法(fa)規規定(ding)的(de)(de)基(ji)本條(tiao)件和(he)能力(li)(li)，可(ke)以向社會出(chu)具具有(you)證(zheng)(zheng)(zheng)(zheng)(zheng)明(ming)作用(yong)的(de)(de)數據和(he)結果(guo)(guo)，資(zi)(zi)質(zhi)(zhi)認(ren)(ren)定(ding)包括檢(jian)(jian)(jian)(jian)(jian)驗(yan)(yan)檢(jian)(jian)(jian)(jian)(jian)測機(ji)(ji)(ji)構(gou)計量認(ren)(ren)證(zheng)(zheng)(zheng)(zheng)(zheng)，檢(jian)(jian)(jian)(jian)(jian)測能力(li)(li)范圍(wei)認(ren)(ren)可(ke)和(he)出(chu)具的(de)(de)檢(jian)(jian)(jian)(jian)(jian)測報告可(ke)使用(yong)CMA資(zi)(zi)質(zhi)(zhi)認(ren)(ren)定(ding)標志。因此，CMA認(ren)(ren)證(zheng)(zheng)(zheng)(zheng)(zheng)提升了檢(jian)(jian)(jian)(jian)(jian)測機(ji)(ji)(ji)構(gou)的(de)(de)檢(jian)(jian)(jian)(jian)(jian)測能力(li)(li)范圍(wei)、實(shi)驗(yan)(yan)能力(li)(li)、檢(jian)(jian)(jian)(jian)(jian)測結果(guo)(guo)判斷力(li)(li)的(de)(de)公信力(li)(li)和(he)權威性(xing)，夯(hang)實(shi)了檢(jian)(jian)(jian)(jian)(jian)測行業(ye)壁(bi)壘。持有(you)CMA證(zheng)(zheng)(zheng)(zheng)(zheng)書(shu)的(de)(de)第三方檢(jian)(jian)(jian)(jian)(jian)測機(ji)(ji)(ji)構(gou)出(chu)具的(de)(de)檢(jian)(jian)(jian)(jian)(jian)測報告具有(you)無可(ke)爭議的(de)(de)公信力(li)(li)和(he)權威性(xing)。

中國(guo)(guo)(guo)(guo)合格(ge)評定國(guo)(guo)(guo)(guo)家(jia)(jia)(jia)認(ren)(ren)(ren)可(ke)(ke)(ke)委員(yuan)會(hui)（CNAS）由國(guo)(guo)(guo)(guo)家(jia)(jia)(jia)認(ren)(ren)(ren)證(zheng)(zheng)認(ren)(ren)(ren)可(ke)(ke)(ke)監(jian)督管理委員(yuan)會(hui)批準設立并授權的(de)國(guo)(guo)(guo)(guo)家(jia)(jia)(jia)認(ren)(ren)(ren)可(ke)(ke)(ke)機(ji)(ji)(ji)構(gou)(gou)(gou)，是我國(guo)(guo)(guo)(guo)目(mu)前唯一(yi)的(de)，也是最(zui)權威(wei)(wei)(wei)的(de)實(shi)驗室(shi)評審機(ji)(ji)(ji)構(gou)(gou)(gou)。在其認(ren)(ren)(ren)可(ke)(ke)(ke)范(fan)圍(wei)內，檢(jian)(jian)驗檢(jian)(jian)測(ce)(ce)機(ji)(ji)(ji)構(gou)(gou)(gou)所(suo)出具的(de)檢(jian)(jian)測(ce)(ce)報(bao)告具有國(guo)(guo)(guo)(guo)際公(gong)信力(li)(li)和(he)權威(wei)(wei)(wei)性。CNAS認(ren)(ren)(ren)證(zheng)(zheng)已(yi)被(bei)72個國(guo)(guo)(guo)(guo)家(jia)(jia)(jia)、3個聯(lian)合經濟體、5個區域組(zu)織集團承認(ren)(ren)(ren)。CNAS認(ren)(ren)(ren)證(zheng)(zheng)是在上述國(guo)(guo)(guo)(guo)家(jia)(jia)(jia)或區域中開(kai)展(zhan)生物(wu)創新藥申報(bao)檢(jian)(jian)測(ce)(ce)業務的(de)前提。在國(guo)(guo)(guo)(guo)內，選擇CNAS認(ren)(ren)(ren)證(zheng)(zheng)的(de)第三方檢(jian)(jian)測(ce)(ce)機(ji)(ji)(ji)構(gou)(gou)(gou)是《藥品GMP指南》之《質量控制實(shi)驗室(shi)與物(wu)料系統》指導性規范(fan)的(de)要求。CNAS認(ren)(ren)(ren)證(zheng)(zheng)提升了(le)(le)檢(jian)(jian)測(ce)(ce)機(ji)(ji)(ji)構(gou)(gou)(gou)的(de)檢(jian)(jian)測(ce)(ce)能(neng)力(li)(li)、實(shi)驗能(neng)力(li)(li)、檢(jian)(jian)測(ce)(ce)結果判斷力(li)(li)的(de)公(gong)信力(li)(li)和(he)權威(wei)(wei)(wei)性，夯實(shi)了(le)(le)檢(jian)(jian)測(ce)(ce)行(xing)業壁壘。持(chi)有CNAS 證(zheng)(zheng)書的(de)第三方檢(jian)(jian)測(ce)(ce)機(ji)(ji)(ji)構(gou)(gou)(gou)出具的(de)檢(jian)(jian)測(ce)(ce)報(bao)告具有國(guo)(guo)(guo)(guo)際認(ren)(ren)(ren)可(ke)(ke)(ke)的(de)公(gong)信力(li)(li)和(he)權威(wei)(wei)(wei)性。

檢(jian)(jian)(jian)(jian)測(ce)機(ji)構所(suo)從(cong)事的(de)檢(jian)(jian)(jian)(jian)測(ce)活(huo)動涉及病(bing)原(yuan)微(wei)(wei)生(sheng)(sheng)(sheng)(sheng)物(wu)菌（毒）種檢(jian)(jian)(jian)(jian)測(ce)活(huo)動，需要建立符(fu)合(he)國(guo)家標準和要求的(de)生(sheng)(sheng)(sheng)(sheng)物(wu)安(an)全實驗(yan)室(shi),并根據(ju)《病(bing)原(yuan)微(wei)(wei)生(sheng)(sheng)(sheng)(sheng)物(wu)實驗(yan)室(shi)生(sheng)(sheng)(sheng)(sheng)物(wu)安(an)全管理條(tiao)例》的(de)規定進(jin)行備案(an)。未(wei)在規定時限內備案(an)的(de)實驗(yan)室(shi)以及備案(an)與(yu)擬開(kai)展的(de)工作不相(xiang)符(fu)合(he)的(de)實驗(yan)室(shi)不得從(cong)事相(xiang)應實驗(yan)活(huo)動。因此，生(sheng)(sheng)(sheng)(sheng)物(wu)安(an)全實驗(yan)室(shi)（BSL-2）備案(an)憑(ping)證也屬于開(kai)展涉及病(bing)原(yuan)微(wei)(wei)生(sheng)(sheng)(sheng)(sheng)物(wu)檢(jian)(jian)(jian)(jian)測(ce)業務(wu)的(de)檢(jian)(jian)(jian)(jian)測(ce)行業壁壘。持有（BSL-2）備案(an) 證書的(de)第三方檢(jian)(jian)(jian)(jian)測(ce)機(ji)構證明(ming)其檢(jian)(jian)(jian)(jian)測(ce)實驗(yan)條(tiao)件的(de)合(he)規合(he)法性。

通常國內第三方(fang)檢(jian)測(ce)機(ji)構開(kai)展(zhan)藥品/生物制品細胞檢(jian)測(ce)應取得質量管(guan)(guan)理體(ti)系認(ren)(ren)證(zheng)（GB/T 19001-2016/ISO 9001：2015）證(zheng)書(shu)、職業健康(kang)安全(quan)管(guan)(guan)理體(ti)系認(ren)(ren)證(zheng)（GB/T 45001-2020/ISO 45001：2018）證(zheng)書(shu)、環境管(guan)(guan)理體(ti)系認(ren)(ren)證(zheng)（GB/T 24001-2016/ISO 14001：2015）證(zheng)書(shu)等(deng)。該(gai)等(deng)級(ji)證(zheng)書(shu)均為提升檢(jian)測(ce)機(ji)構的公信力和權威(wei)性、標準化管(guan)(guan)理能力、職業健康(kang)管(guan)(guan)理能力等(deng)而自愿申請取得，并(bing)非(fei)公司開(kai)展(zhan)業務所必須的認(ren)(ren)證(zheng)，亦不屬于公司的行業壁壘。