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長春百克(ke)生物科技股(gu)份(fen)公司參照ISO 9000及(ji) ICH Q10建立質(zhi)(zhi)(zhi)(zhi)量(liang)手冊,明確(que)質(zhi)(zhi)(zhi)(zhi)量(liang)方針(zhen)(zhen),并圍繞(rao)質(zhi)(zhi)(zhi)(zhi)量(liang)方針(zhen)(zhen)制定(ding)質(zhi)(zhi)(zhi)(zhi)量(liang)目(mu)標等內容。質(zhi)(zhi)(zhi)(zhi)量(liang)管理(li)(li)體系(xi)(xi)(xi)按系(xi)(xi)(xi)統(tong)(tong)(tong)分成六(liu)大系(xi)(xi)(xi)統(tong)(tong)(tong),分別為(wei)人員管理(li)(li)系(xi)(xi)(xi)統(tong)(tong)(tong)、設施(shi)和(he)設備(bei)管理(li)(li)系(xi)(xi)(xi)統(tong)(tong)(tong)、物料(liao)管理(li)(li)系(xi)(xi)(xi)統(tong)(tong)(tong)、實驗(yan)室管理(li)(li)系(xi)(xi)(xi)統(tong)(tong)(tong)、質(zhi)(zhi)(zhi)(zhi)量(liang)保(bao)證管理(li)(li)系(xi)(xi)(xi)統(tong)(tong)(tong)、生產管理(li)(li)系(xi)(xi)(xi)統(tong)(tong)(tong)。在各系(xi)(xi)(xi)統(tong)(tong)(tong)中將GMP的(de)(de)(de)主要因素進行了詳細(xi)的(de)(de)(de)描述,按系(xi)統建立了相關的(de)(de)(de)程(cheng)序(xu)文(wen)件并對產(chan)品從設計開(kai)發(fa)、臨床階段到產(chan)品的(de)(de)(de)生產(chan)、儲存、銷(xiao)售、售后服務的(de)(de)(de)全生命(ming)周(zhou)期進行控制。公司通過偏差管理、CAPA管理(li)、變更控(kong)制管理(li)、質(zhi)量風險(xian)管理(li)、自(zi)檢等質(zhi)量運營手段,不斷促進質(zhi)量管理(li)體系持續(xu)改進,保證產品(pin)的安全性、有效性和質(zhi)量可控(kong)性。