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3广西壮族自治区药品经营质量管理规范认证检查细则(2017年修订)4说明一、为规范药品经营质量管理规范检查工作,确保检查工作质量,根据药品经营质量管理规范、药品经营质量管理规范现场检查指导原则,制定广西壮族自治区药品经营质量管理规范认证检查细则(2017年修订)。二、应当按照本细则中包含的检查项目,对药品经营企业实施药品经营质量管理规范情况进行全面检查。三、本检查细则检查项目分三部分。批发企业检查项目共256项,其中严重缺陷项目(*)10项,主要缺陷项目(*)103项,一般缺陷项目143项;零售企业检查项目共176项,其中严重缺陷项目(*)8项,主要缺陷项(*)53项,一般缺陷项115项;体外诊断试剂(药品)经营企业检查项目共185项,其中严重缺陷项目(*)9项,主要缺陷项(*)70项,一般缺陷项106项。四、药品零售连锁企业总部及配送中心按照药品批发企业检查项目检查,药品零售连锁企业门店按照药品零售企业检查项目检查。五、药品生产企业销售药品,以及药品流通过程中其他涉及药品储存、运输的,参照本检查细则有关检查项目检查。5六、认证检查结果判定:检查项目严重缺陷项目(*)主要缺陷项目(*)一般缺陷项目结果判定0020%通过检查0020%30%010%20%限期整改后复核检查1-010%-010%20%0030%不通过检查g4447g289g3052g3754g3771g2690g913g2376g3316=g1395g4075g1285g3052g3754g3771g2690g4399g994g1528g1766g3771g2690g3316/g271g1395g4075g3052g3754g3771g2690g4505g3316-g1395g4075g3052g3754g1983g1040g3771g2690g1766g2360g3052g3771g3316g272100%g1006七、监督检查结果判定:g1983g1040g3771g2690g3928g4407g3052g3754g3771g2690g271*g272g4438g3985g3052g3754g3771g2690g271*g272g4002g846g3052g3754g3771g2690g2066g1716g2801g1351000g1528g1766g3984g2870g2108g4079g4393g2408g1685g2360g1695g1459g3984g2870g2843g1439g2930g3996g29143g3984g2870g2444g3282g2930g3996g2913400g3480g3571g4336g1390g3275g1940g271g3984g2870g272g2108g4079g2930g3996g29133g3984g2870g2843g1439g2930g3996g29110g3984g2870g2843g1439g2930g3996g29129g3984g2870g2444g3282g2930g3996g2915g3984g2870g2444g3282g2930g3996g291230g3480g3571g4336g1390g3275g1940g271g3984g2870g272g2108g4079g2930g3996g2917g3480g3571g4336g1390g3275g1940g271g3984g2870g272g2108g4079g2930g3996g29122g3604g1457g3984g2870g2108g4079g4393g2408g1685g2360g1695g1459g275g3755g2905g4348g15671-g3984g2870g2843g1439g2930g399610g3984g2870g2444g3282g2930g399650g3480g3571g4336g1390g3275g1940g271g3984g2870g272g2108g4079g2930g39967-g3984g2870g2843g1439g2930g3996g29110g3984g2870g2843g1439g2930g399629g3984g2870g2444g3282g2930g3996g2915g3984g2870g2444g3282g2930g3996230g3480g3571g4336g1390g3275g1940g271g3984g2870g272g2108g4079g2930g3996g2917g3480g3571g4336g1390g3275g1940g271g3984g2870g272g2108g4079g2930g399622g3984g2870g2843g1439g2930g399643g3984g2870g2444g3282g2930g39963400g3480g3571g4336g1390g3275g1940g271g3984g2870g272g2108g4079g2930g399633g3928g4407g3604g1457g3984g2870g2108g4079g4393g2408g1685g2360g1695g1459g275g1084g3783g119g3984g2870g2108g4079g4393g2408g1685g2360g1695g1459g3082g4355g4355g3296g1207八、合理缺陷项目:(一)药品批发企业合理缺项参考表项目数量g3g3g3g3合理缺项严重缺陷主要缺陷一般缺陷条款号g994g2108g4079g4399g3984g100300402207g9904802g9908002g9909202g994g4368g2052g3276g1651g1305g1057g4399g3984g100300202207g9904802g994g2108g4079g4399g3984g4066g2859034*02205g9902206g99*04801g9908003g99*08310g9908408g9909203g994g1206g3257g4038g2636g2821g3362111*02208g9904202g99*04902g994g2108g4079g3467g3289g1685g2360g3984g2870081*02801g9904203g99*04710g99*07001g99*07901g99*08311g99*08704g99*09601g99*11201g994g2108g4079g2351g1023g99g2351g1362g3984g28700156*02802g99*04901g99*04903g9904904g9904905g99*04906g99*04907g99*05101g99*05102g99*05103g99*05302g99*05304g99*07401g99*07502g9909901g9909902g99*09903g9909904g9909905g99*10501g99*10601g3619g3614g3553g4206g3291024*01716g99*10701g9910801g9910901g9910902g9911002g3821g2199g85544177*06101-119018(二)药品零售企业合理缺项参考表项目数量合理缺项严重缺陷主要缺陷一般缺陷条款号不经营中药饮片001012602、12604、14503、15403、16112、16113、16114、16115、16706、16707不经营特殊管理药品03214002、*14505、*14901、*15701、16109不经营冷藏药品121*14504、*15501、*16110、16111不设置仓库1122714701、14801、14802、*14803、14804、14805、14806、*14807、15001、16401、*16402、16403、16404、16405、16406、*16407、*16408、*16409、*16410、*16411、*16412、16413、16414、16415、16416、16417、16418、*16419、16420、16421、*16422、16423、16424、16425、16426、16427、*16428、*16429、16430、16431新开办23172*15201-177019(三)体外诊断试剂(药品)经营企业合理缺陷参考项目数量合理缺项严重缺陷主要缺陷一般缺陷条款号g3619g3614g3553g4206g3291024*01716、*10701、10801、10901、10902、11001新开办32247*06101-1190110第一部分药品批发企业g5219g2507g7477g8466g2507g7828g7609g20045g11458g7828g7609g13466g20291*00201g1329g1098g5316g5507g3416g14751g2801g18423g17245g451g1752g4488g451g19248g2910g451g17920g17859g12665g10719g14514g18423g2566g7481g7032g11444g17240g18431g6615g2150g6618g7149g712g11934g1549g14751g2801g17240g18431g712g5286g6457g10135g3373g4582g7481g1955g16305g8818g5418g12539g14751g2801g17965g9439g13099g13583g712g4558g10720g14751g2801g2591g17965g9439g4521.g1329g1098g5316g5507g6457g10135g457g14751g2801g13567g14933g17240g18431g12753g10806g16372g14643g458g708g1301g1083g12720g12320g457g16372g14643g458g709g2748g11560g1955g8965g5563g451g8965g16372g451g18200g19480g16372g12560g451g3424g7145g7569g1467g2748g16372g14643g5719g7095g1318g11444g16305g8818g712g3416g14751g2801g18423g17245g451g1752g4488g451g19248g2910g451g17920g17859g12665g10719g14514g18423g2566g7481g7032g11444g17240g18431g6615g2150g6618g7149g712g11934g1549g14751g2801g17240g18431g4522.g1329g1098g5316g6457g10135g457g3373g2257g19602g2254g1948g2485g1955g1214g2256g5659g6616g17931g18429g16305g1239g2801g17965g9439g1411g13099g5418g16878g11444g5951g16369g458g708g3373g2254g2561g4662015g46795g2599g709g451g457g5739g4720g1955g1214g6616g2264g20239g2801g14751g2801g11087g1239g13567g14933g13877g4540g2996g17965g9439g1411g13099g11444g5951g16369g458g708g20239g14751g11521g12289g4662016g467122g2599g709g2748g4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