【正文】 179209306090120150180210表43瓶號剔除次數(shù)瓶號剔除次數(shù)瓶號剔除次數(shù)瓶號剔除次數(shù)瓶號剔除次數(shù)瓶號剔除次數(shù)瓶號剔除次數(shù)211224237250263276289212225238251264277290213226239252265278291214227240253266279292215228241254267280293216229242255268281294217230243256269282295218231244257270283296219232245258271284297220233246259272285298221234247260273286299222235248261274287300223236249262275288表44江西制藥有限責任公司質(zhì)量因素明細表（FQA—人工）瓶號質(zhì)量因素瓶號質(zhì)量因素瓶號質(zhì)量因素瓶號質(zhì)量因素瓶號質(zhì)量因素瓶號質(zhì)量因素瓶號質(zhì)量因素131619112115118123262921221521823336393123153183434649412415418453565951251551856366696126156186737679712715718783868981281581889396999129159189104070100130160190114171101131161191124272102132162192134373103133163193144474104134164194154575105135165195164676106136166196174777107137167197184878108138168198194979109139169199205080110140170200215181111141171201225282112142172202235383113143173203245484114144174204255585115145175205265686116146176206275787117147177207285888118148178208295989119149179209306090120150180210表44瓶號質(zhì)量因素瓶號質(zhì)量因素瓶號質(zhì)量因素瓶號質(zhì)量因素瓶號質(zhì)量因素瓶號質(zhì)量因素瓶號質(zhì)量因素211224237250263276289212225238251264277290213226239252265278291214227240253266279292215228241254267280293216229242255268281294217230243256269282295218231244257270283296219232245258271284297220233246259272285298221234247260273286299222235248261274287300223236249262275288表45江西制藥有限責任公司質(zhì)量因素明細表（FQB—機器）瓶號質(zhì)量因素瓶號質(zhì)量因素瓶號質(zhì)量因素瓶號質(zhì)量因素瓶號質(zhì)量因素瓶號質(zhì)量因素瓶號質(zhì)量因素131619112115118123262921221521823336393123153183434649412415418453565951251551856366696126156186737679712715718783868981281581889396999129159189104070100130160190114171101131161191124272102132162192134373103133163193144474104134164194154575105135165195164676106136166196174777107137167197184878108138168198194979109139169199205080110140170200215181111141171201225282112142172202235383113143173203245484114144174204255585115145175205265686116146176206275787117147177207285888118148178208295989119149179209306090120150180210表45瓶號質(zhì)量因素瓶號質(zhì)量因素瓶號質(zhì)量因素瓶號質(zhì)量因素瓶號質(zhì)量因素瓶號質(zhì)量因素瓶號質(zhì)量因素211224237250263276289212225238251264277290213226239252265278291214227240253266279292215228241254267280293216229242255268281294217230243256269282295218231244257270283296219232245258271284297220233246259272285298221234247260273286299222235248261274287300223236249262275288表46江 西 制 藥 有 限 責 任 公 司Knapp測試效能表品名：硫酸小諾霉素注射液規(guī)格：1ml：3萬單位批號：1305151人工測試剔除效能（FQA）機器測試剔除效能（FQB）效能比值（FQB/FQA）*100%左側(cè)區(qū)右側(cè)區(qū)左側(cè)區(qū)右側(cè)區(qū)可接受標準：效能比值應高于100%，說明機器檢測優(yōu)于人工檢測。結論：□符合要求 □不符合要求操作者：日期： 年 月 日復核者：表47江西制藥有限責任公司人機對比數(shù)據(jù)表燈檢機左檢測區(qū)品名：硫酸小諾霉素注射液規(guī)格：1ml:3萬單位批號：機 檢“未檢藥品數(shù)據(jù)”人工復查合格品、不合格品確認機檢漏檢數(shù)、機檢不合格品準確數(shù)機 檢漏檢率機檢不合格品準確率機 檢“人檢后的合格品”數(shù) 據(jù)人工復查不合格品數(shù)確認人工漏檢數(shù)人 工漏檢率總檢數(shù)總檢數(shù)合格品數(shù)合格品數(shù)不合格品數(shù)不合格品數(shù)合格率合格率破損率破損率可接受標準機檢合格品中不得檢出明顯可見異物，‰1‰，機檢不合格品準確率應達到90%以上，破損率：≤%結論：□符合要求 □不符合要求操作者：日期： 年 月 日復核者：燈檢機右檢測區(qū)品名：硫酸小諾霉素注射液規(guī)格：1ml:3萬單位批號：機 檢“未檢藥品數(shù)據(jù)”人工復查合格品、不合格品確認機檢漏檢數(shù)、機檢不合格品準確數(shù)機 檢漏檢率機檢不合格品準確率機 檢“人檢后的合格品”數(shù) 據(jù)人工復查不合格品數(shù)確認人工漏檢數(shù)