文章(zhang)來源:中(zhong)國中(zhong)化集團公司(si) 發布時間:2008-12-07
近日(ri),在全(quan)國(guo)農(nong)(nong)(nong)藥(yao)登記(ji)毒(du)(du)理學試驗(yan)管理工(gong)作(zuo)會(hui)議上,中(zhong)(zhong)國(guo)中(zhong)(zhong)化集團公司(簡稱“中(zhong)(zhong)化集團”)下(xia)屬企業沈陽(yang)化工(gong)研究院(yuan)(簡稱“沈陽(yang)院(yuan)”)的安全(quan)評價中(zhong)(zhong)心(xin)(xin)獲(huo)(huo)得A級資質。此次會(hui)議由沈陽(yang)院(yuan)安全(quan)評價中(zhong)(zhong)心(xin)(xin)與農(nong)(nong)(nong)業部(bu)農(nong)(nong)(nong)藥(yao)檢定所共同舉(ju)辦(ban),全(quan)國(guo)35家毒(du)(du)理學試驗(yan)單位獲(huo)(huo)得了(le)資質證書。
沈(shen)(shen)陽(yang)院(yuan)安全(quan)評(ping)(ping)(ping)(ping)價(jia)中心主(zhu)要從(cong)事農(nong)(nong)(nong)藥、醫藥及其它精細化學(xue)品的安全(quan)性研(yan)究工作(zuo)(zuo),擁(yong)有每年實(shi)(shi)施(shi)1200多個實(shi)(shi)驗(yan)(yan)(yan)(yan)(yan)(yan)項目(mu)的能(neng)力(li)(li),是目(mu)前國(guo)(guo)內唯(wei)一(yi)能(neng)夠(gou)同時(shi)從(cong)事農(nong)(nong)(nong)藥、醫藥以及化學(xue)品的安全(quan)評(ping)(ping)(ping)(ping)價(jia)試驗(yan)(yan)(yan)(yan)(yan)(yan)機構。近年來,沈(shen)(shen)陽(yang)院(yuan)安全(quan)評(ping)(ping)(ping)(ping)價(jia)中心積極探(tan)索與國(guo)(guo)際(ji)接(jie)軌,推(tui)進GLP(Good Laboratory Practice)實(shi)(shi)驗(yan)(yan)(yan)(yan)(yan)(yan)室建設(she),建成(cheng)了(le)(le)接(jie)近國(guo)(guo)際(ji)水(shui)準的安全(quan)評(ping)(ping)(ping)(ping)價(jia)機構,先后被國(guo)(guo)家認(ren)證為“化學(xue)工業農(nong)(nong)(nong)藥安全(quan)評(ping)(ping)(ping)(ping)價(jia)質量監督檢(jian)驗(yan)(yan)(yan)(yan)(yan)(yan)中心”和(he)“國(guo)(guo)家沈(shen)(shen)陽(yang)新藥安全(quan)評(ping)(ping)(ping)(ping)價(jia)研(yan)究中心”,在(zai)2006年又通過了(le)(le)國(guo)(guo)家實(shi)(shi)驗(yan)(yan)(yan)(yan)(yan)(yan)室認(ren)可委(wei)員會(hui)的國(guo)(guo)家實(shi)(shi)驗(yan)(yan)(yan)(yan)(yan)(yan)室認(ren)證檢(jian)查(cha)及美國(guo)(guo)AAALAC(國(guo)(guo)際(ji)實(shi)(shi)驗(yan)(yan)(yan)(yan)(yan)(yan)動(dong)(dong)物委(wei)托和(he)評(ping)(ping)(ping)(ping)估委(wei)員會(hui))的正(zheng)式認(ren)證檢(jian)查(cha)。此次與農(nong)(nong)(nong)業部農(nong)(nong)(nong)藥檢(jian)定所共同舉辦全(quan)國(guo)(guo)農(nong)(nong)(nong)藥登記毒理學(xue)試驗(yan)(yan)(yan)(yan)(yan)(yan)管理工作(zuo)(zuo)會(hui)議(yi)及有關培訓活(huo)動(dong)(dong),進一(yi)步(bu)鞏固和(he)提(ti)升了(le)(le)沈(shen)(shen)陽(yang)院(yuan)安全(quan)評(ping)(ping)(ping)(ping)價(jia)中心在(zai)我國(guo)(guo)農(nong)(nong)(nong)藥GLP實(shi)(shi)驗(yan)(yan)(yan)(yan)(yan)(yan)室建設(she)以及毒理學(xue)試驗(yan)(yan)(yan)(yan)(yan)(yan)能(neng)力(li)(li)等方面(mian)的領(ling)先地位(wei)。
GLP是針對試驗研究計劃、試驗操作、監督、記錄和試驗報告等一系列試驗流程的管理而制定的法規性文件,旨在嚴格控制各類化學品安全性評價試驗的各個環節,確保試驗結果的真實性。