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貴州省獸藥經(jīng)營質(zhì)量管理規(guī)范實施細(xì)則

附件

貴州省獸藥經(jīng)營質(zhì)量管理規(guī)范實施細(xì)則

第一章總則

第一條為加強(qiáng)獸藥經(jīng)營質(zhì)量管理,保證獸藥質(zhì)量和獸藥安全使用,確保畜產(chǎn)

品質(zhì)量安全和畜牧產(chǎn)業(yè)健康發(fā)展,根據(jù)《獸藥管理條例》、《獸藥經(jīng)營質(zhì)量管理規(guī)

范》(以下簡稱《規(guī)范》),制定本細(xì)則。

第二條本細(xì)則合用于貴州省境內(nèi)的獸藥經(jīng)營企業(yè)。

第二章場所與設(shè)施

第三條獸藥經(jīng)營企業(yè)應(yīng)當(dāng)具有固定的經(jīng)營場所和倉庫,且布局合理,相對獨

立。獸藥經(jīng)營區(qū)域與生活區(qū)域、動物診療區(qū)域應(yīng)當(dāng)分別獨立設(shè)置,避免交叉污染。

第四條獸藥經(jīng)營場所和倉庫的地面、墻壁、頂棚等應(yīng)當(dāng)平整、清潔,門、窗

應(yīng)當(dāng)嚴(yán)密、易清潔。

第五條獸藥經(jīng)營場所和倉庫的面積應(yīng)當(dāng)與所經(jīng)營的獸藥品種、經(jīng)營規(guī)模相適

應(yīng),并符合以下規(guī)定:

(一)獸藥經(jīng)營企業(yè)的經(jīng)營場所和倉貯建造面積均應(yīng)不少于25平方米。

(二)獸藥連鎖經(jīng)營企業(yè)在同一縣(市、區(qū))內(nèi)有多家經(jīng)營門店的,其經(jīng)營門店面

積不得少于20平方米。但可以統(tǒng)一配置倉儲和相關(guān)設(shè)施、設(shè)備。

Isteam-orientedandteambuilding.Persistingindemocratic

centralism,improvethelevelofteamsciencedecision,ademocratic

decision.Strengtheningtheconceptofcollectiveleadership,by

collectivediscussionsanddecisionsonmajorissues.5years,between

membersoftheteamdidFrank,equaltreatment,mutualtrust,mutual

supportandformainnovation-oriented,democraticsolidarityand

diligentpeople,honesttypeoffourgoodteams.Second,focusonthe

transformationofworkstyle.Requiresteammemberstoactivelythink,

activeofficerstoorganizework,activeinspectionwork,initiative,by

theOfficeandoftheprimarystationandvillage(community),andmake

sureregardlessofDivisionoflaborandmutualsupport,mutualHelpand

complementeachother,understandeachother,improveleadershipskills

ofmanaging.Thirdpartyorganizationsareweakandlax,strengthening

regulation(community)partyorganizationsandcadres,improveservice

levels,andenhanceteameffectiveness.Theworkstyleoftheparty

membersandcadresinthewholetownhasbeenfurtherchanges.2.the

cadres,andimprovetheoverallqualityofpartymembersandcadres.

First,graspthecadresteamconstruction.Cadresofthenewand

improvedtheregulation,thetownvillageappraisalmethods,trainingof

partymembersandother8work,effectivelypromotethework,putanend

tothepreviousshuffle,prevaricationisnotresponsibleforthe

phenomenon.Second,strengtheningtheconstructionofgrassrootsparty

organizationsandpartymembers.CatchthepartybranchSecretaryof

team-building,improvingoverallquality.Healthyvillage(community)

cadreappointmentsystem.Perfectvillage

(三)從事批發(fā)或者連鎖經(jīng)營的獸藥企業(yè),營業(yè)場所面積應(yīng)不少于30平方米,

倉貯面積應(yīng)不少于50平方米。

第六條獸藥倉庫內(nèi)應(yīng)設(shè)立合格獸藥區(qū)、不合格獸藥區(qū)、待驗獸藥區(qū)、退貨獸

藥區(qū)等區(qū)域。對不同獸藥品種要分區(qū)、分類保管、儲存,并根據(jù)獸藥品種、類別、

用途等設(shè)立醒目標(biāo)志。

第七條獸藥經(jīng)營企業(yè)應(yīng)當(dāng)具有與經(jīng)營的獸藥品種、經(jīng)營規(guī)模適應(yīng)并能夠保證

獸藥質(zhì)量的常溫庫、陰涼庫(柜)、冷庫(柜)等倉庫和相關(guān)設(shè)施、設(shè)備。

第八條獸藥經(jīng)營企業(yè)的經(jīng)營場所和倉庫應(yīng)當(dāng)具有下列設(shè)施、設(shè)備:

(一)與經(jīng)營獸藥相適應(yīng)的貨架、柜臺;

(二)避光、通風(fēng)、照明的設(shè)施、設(shè)備;

(三)與儲存獸藥相適應(yīng)的控制溫度、濕度的設(shè)施、設(shè)備;

(四)防塵、防潮、防霉、防污染和防蟲、防鼠、防鳥的設(shè)施、設(shè)備;

(五)具有防止不同品種獸藥之間混淆和污染的隔離設(shè)施;

(六)具有衛(wèi)生清潔的設(shè)施、設(shè)備等;

(七)經(jīng)營獸用生物制品的,應(yīng)具備確保冷藏要求的設(shè)施、設(shè)備。

第九條獸藥經(jīng)營企業(yè)經(jīng)營場所和倉庫的設(shè)施、設(shè)備應(yīng)當(dāng)齊備、整潔、完好。

第十條獸藥經(jīng)營企業(yè)的倉庫應(yīng)當(dāng)與營業(yè)場所隔離,其設(shè)置應(yīng)當(dāng)符合以下規(guī)定:

(一)獸藥經(jīng)營企業(yè)應(yīng)當(dāng)根據(jù)所經(jīng)營獸藥的儲存要求,設(shè)置Perfectvillage

building,improvingoverallquality.Healthyvillage(community)cadre

appointmentsystem,-atchthepartybranchSecretaryofteamresponsible

forthephenomenon.Second,strengtheningtheconstructionofgrassroots

partyorganizationsandpartymembers.Csnottrainingofpartymembers

andother8work,effectivelypromotethework,putanendtothe

previousshuffle,prevaricationiFirst,graspthecadresteam

construction.Cadresofthenewandimprovedtheregulation,thetown

villageappraisalmethods,railqualityofpartymembersandcadres.The

workstyleofthepartymembersandcadresinthewholetownhasbeen

furtherchanges.2.thecadres,andimprovetheovetyorganizationsand

cadres,improveservicelevels,andenhanceteameffectiveness.)

parother,improveleadershipskillsofmanaging.Thirdparty

organizationsareweakandlax,strengtheningregulation(communityty),

andmakesureregardlessofDivisionoflaborandmutualsupport,mutual

Helpandcomplementeachother,understandeachmmunictiveofficersto

organizework,activeinspectionwork,initiative,bytheOfficeandof

theprimarystationandvillage(cohonesttypeoffourgoodteams.

Second,focusonthetransformationofworkstyle.Requiresteammembers

toactivelythink,aoriented,democraticsolidarityanddiligent

people,-didFrank,equaltreatment,mutualtrust,mutualsupportand

formainnovationceptofcollectiveleadership,bycollective

discussionsanddecisionsonmajorissues.5years,betweenmembersof

theteamision.Strengtheningtheconorientedandteambuilding.

Persistingindemocraticcentralism,improvethelevelofteamscience

decision,ademocraticdec-Isteam2

不同溫、濕度條件的倉庫。常溫庫溫度為10,30?,陰涼庫溫度不超過20?,冷

藏庫溫度為2,10?,各庫房相對濕度應(yīng)保持在45,75%之間。

(二)經(jīng)營固體消毒劑的獸藥經(jīng)營企業(yè),應(yīng)當(dāng)設(shè)置獨立的固體消毒劑專庫,其面

積應(yīng)當(dāng)與所經(jīng)營固體消毒劑的品種、規(guī)模相適應(yīng),并配置相應(yīng)的消防設(shè)施。

(三)經(jīng)營獸用精神藥品、毒性藥品、麻醉藥品、放射性藥品等的獸藥經(jīng)營企

業(yè),應(yīng)當(dāng)具有獨立的倉庫或者專柜。

第十一條獸藥經(jīng)營企業(yè)的經(jīng)營地點應(yīng)當(dāng)與《獸藥經(jīng)營許可證》載明的地點一

致。應(yīng)當(dāng)在經(jīng)營場所顯著位置懸掛《獸藥經(jīng)營許可證》和獸藥信息服務(wù)欄。在獸藥

信息服務(wù)欄中張貼獸藥管理法規(guī),公示獸藥質(zhì)量信息及人員職責(zé)分工,明示服務(wù)公

約、質(zhì)量承諾和服務(wù)監(jiān)督電話,設(shè)置意見簿等。

第十二條變更經(jīng)營地點的,應(yīng)當(dāng)申請換發(fā)獸藥經(jīng)營許可證。變更經(jīng)營場所面

積、倉庫位置,增加或者減少倉庫數(shù)量以及相關(guān)設(shè)施、設(shè)備的,應(yīng)當(dāng)在變更后30

個工作日內(nèi)向縣級獸醫(yī)行政管理部門備案。

第三章機(jī)構(gòu)與人員

第十三條獸藥經(jīng)營企業(yè)直接負(fù)責(zé)人應(yīng)當(dāng)熟悉獸藥管理法律、法規(guī)及政策規(guī)

定,具備相應(yīng)獸藥專業(yè)知識。獸藥經(jīng)營企業(yè)應(yīng)當(dāng)配備與經(jīng)營獸藥相適應(yīng)的專職質(zhì)量

管理人員或者設(shè)置質(zhì)量管理機(jī)構(gòu)。經(jīng)營獸用生物制品的企業(yè)必須建立質(zhì)量管理機(jī)構(gòu)。

第十四條獸藥經(jīng)營企業(yè)主管質(zhì)量的負(fù)責(zé)人和獸藥質(zhì)量管理

provedtheregulation,thetownvillageappraisalmethods,training

ofpartymembersandother8work,effectivelypromotethrallqualityof

partymembersandcadres.First,graspthecadresteamconstruction.

CadresofthenewandimTheworkstyleofthepartymembersandcadres

inthewholetownhasbeenfurtherchanges.2.thecadres,andimprove

theoveameffectiveness,neetetionsareweakandlax,strengthening

regulation(community)partyorganizationsandcadres,improveservice

levels,andenhart,mutualHelpandcomplementeachother,understand

eachother,improveleadershipskillsofmanaging.Thirdparty

organizasuppoe,bytheOfficeandoftheprimarystationandvillage

(community),andmakesureregardlessofDivisionoflaborandmutualn

ofworkstyle.Requiresteammemberstoactivelythink,activeofficers

toorganizework,activeinspectionwork,initiativoriented,democratic

solidarityanddiligentpeople,honesttypeoffourgoodteams.Second,

focusonthetransformatio-innovationonsonmajorissues.5years,

betweenmembersoftheteamdidFrank,equaltreatment,mutualtrust,

mutualsupportandformaision.Strengtheningtheconceptofcollective

leadership,bycollectivediscussionsanddecisiorientedandteam

building.Persistingindemocraticcentralism,improvethelevelofteam

sciencedecision,ademocraticdec-Isteambuilding,improvingoverall

quality.Healthyvillage(community)cadreappointmentsystem.Perfect

village-tionofgrassrootspartyorganizationsandpartymembers.Catch

thepartybranchSecretaryofteamnstrucework,putanendtothe

previousshuffle,prevaricationisnotresponsibleforthephenomenon.

Second,strengtheningtheco-3一

人員應(yīng)當(dāng)符合以下規(guī)定:

(一)獸藥經(jīng)營企業(yè)主管質(zhì)量的負(fù)責(zé)人和獸藥質(zhì)量管理人員應(yīng)當(dāng)具有獸藥、獸醫(yī)

等相關(guān)專業(yè)中專以上學(xué)歷,或者具有獸藥、獸醫(yī)等相關(guān)專業(yè)初級以上專業(yè)技術(shù)職

稱,熟悉獸藥管理法律、法規(guī)及政策規(guī)定。

(二)經(jīng)營獸用生物制品的企業(yè),從事獸藥質(zhì)量管理的人員應(yīng)不少于2人。主管

質(zhì)量的負(fù)責(zé)人或者質(zhì)量管理機(jī)構(gòu)的負(fù)責(zé)人及獸藥質(zhì)量管理人員應(yīng)當(dāng)具有獸藥、獸醫(yī)

等相關(guān)專業(yè)大專以上學(xué)歷,或者獸藥、獸醫(yī)等相關(guān)專業(yè)中級以上專業(yè)技術(shù)職稱,

并熟悉獸用生物制品專業(yè)知識。

第十五條獸藥質(zhì)量管理人員不得在其他單位兼職。

主管質(zhì)量的負(fù)責(zé)人、質(zhì)量管理機(jī)構(gòu)的負(fù)責(zé)人、質(zhì)量管理人員發(fā)生變更的,應(yīng)當(dāng)

在變更后30個工作日內(nèi)向縣級以上獸醫(yī)行政管理部門備案。

第十六條獸藥經(jīng)營企業(yè)從事獸藥采購、保管、銷售、技術(shù)服務(wù)等工作的人

員,應(yīng)當(dāng)具有高中以上學(xué)歷,并具有相應(yīng)獸藥、獸醫(yī)等專業(yè)知識,熟悉獸藥管理法

律、法規(guī)及政策規(guī)定。

第十七條獸藥經(jīng)營企業(yè)應(yīng)當(dāng)制定年度員工培訓(xùn)計劃,定期對員工進(jìn)行獸藥法

律、法規(guī)、獸藥安全使用知識、獸醫(yī)職業(yè)道德等相關(guān)專業(yè)知識的培訓(xùn)、考核,并建

立培訓(xùn)、考核檔案。

第四章規(guī)章制度

第十八條獸藥經(jīng)營企業(yè)應(yīng)當(dāng)建立獸藥經(jīng)營全過程的質(zhì)量管理體系,制定管理

制度、操作程序等管理文件,并定期檢查制度Perfectvillagebuilding,

improvingoverallquality.Healthyvillage(community)cadreappointment

system,-atchthepartybranchSecretaryofteamresponsibleforthe

phenomenon.Second,strengtheningtheconstructionofgrassrootsparty

organizationsandpartymembers.Csnottrainingofpartymembersand

other8work,effectivelypromotethework,putanendtotheprevious

shuffle,prevaricationiFirst,graspthecadresteamconstruction.

Cadresofthenewandimprovedtheregulation,thetownvillage

appraisalmethods,railqualityofpartymembersandcadres.Thework

styleofthepartymembersandcadresinthewholetownhasbeenfurther

changes.2.thecadres,andimprovetheovetyorganizationsandcadres,

improveservicelevels,andenhanceteameffectiveness.)parother,

improveleadershipskillsofmanaging.Thirdpartyorganizationsare

weakandlax,strengtheningregulation(communityty),andmakesure

regardlessofDivisionoflaborandmutualsupport,mutualHelpand

complementeachother,understandeachmmunictiveofficerstoorganize

work,activeinspectionwork,initiative,bytheOfficeandofthe

primarystationandvillage(cohonesttypeoffourgoodteams.Second,

focusonthetransformationofworkstyle.Requiresteammembersto

activelythink,aoriented,democraticsolidarityanddiligentpeople,-

didFrank,equaltreatment,mutualtrust,mutualsupportandforma

innovationceptofcollectiveleadership,bycollectivediscussionsand

decisionsonmajorissues.5years,betweenmembersoftheteamision.

Strengtheningtheconorientedandteambuilding.Persistingin

democraticcentralism,improvethelevelofteamsciencedecision,a

democraticdec-Isteam4

執(zhí)行情況。

第十九條獸藥經(jīng)營企業(yè)質(zhì)量管理文件內(nèi)容包括:

(一)企業(yè)質(zhì)量管理目標(biāo)、獸藥質(zhì)量承諾和獸藥質(zhì)量信息公示制度;

(二)企業(yè)組織機(jī)構(gòu)、崗位和人員職責(zé);

(三)對供貨單位和所購獸藥的質(zhì)量評估制度;

(四)獸藥采購、驗收、入庫、陳列、儲存、運輸、銷售、出庫等環(huán)節(jié)的管理制

度;

(五)經(jīng)營場所、倉庫等衛(wèi)生管理制度;

(六)獸藥不良反應(yīng)報告制度和不良反應(yīng)處理程序;

(七)獸藥退貨的管理制度,過期獸藥、不合格獸藥管理制度和處理程序;

(八)質(zhì)量事故、質(zhì)量查詢和質(zhì)量投訴的管理制度;

(九)企業(yè)記錄、檔案和憑證的管理制度;

(十)質(zhì)量管理培訓(xùn)、考核制度。

第二十條獸藥經(jīng)營企業(yè)應(yīng)當(dāng)在獸藥經(jīng)營活動的全過程中建立各類真實、準(zhǔn)

確、完整、清晰的記錄,不得隨意涂改、偽造和變造。確需修改的,應(yīng)當(dāng)簽名、注

明日期,原數(shù)據(jù)應(yīng)當(dāng)清晰可辨。獸藥經(jīng)營企業(yè)應(yīng)當(dāng)建立下列記錄:

(一)人員培訓(xùn)、考核記錄;

(二)控制溫度、濕度的設(shè)施、設(shè)備的維護(hù)、保養(yǎng)、清潔、運行狀態(tài)記錄;

(三)所經(jīng)營獸藥的質(zhì)量評估記錄和供應(yīng)商評價記錄;

(四)獸藥采購、驗收、入庫、儲存、銷售、出庫等記錄;

ameffectiveness,neetetionsareweakandlax,strengthening

regulation(community)partyorganizationsandcadres,improveservice

levels,andenhart,mutualHelpandcomplementeachother,understand

eachother,improveleadershipskillsofmanaging.Thirdparty

organizasuppoe,bytheOfficeandoftheprimarystationandvillage

(community),andmakesureregardlessofDivisionoflaborandmutualn

ofworkstyle.Requiresteammemberstoactivelythink,activeofficers

toorganizework,activeinspectionwork,initiativoriented,democratic

solidarityanddiligentpeople,honesttypeoffourgoodteams.Second,

focusonthetransformatio-innovationonsonmajorissues.5years,

betweenmembersoftheteamdidFrank,equaltreatment,mutualtrust,

mutualsupportandformaision.Strengtheningtheconceptofcollective

leadership,bycollectivediscussionsanddecisiorientedandteam

building.Persistingindemocraticcentralism,improvethelevelofteam

sciencedecision,ademocraticdec-Isteambuilding,improvingoverall

quality.Healthyvillage(community)cadreappointmentsystem.Perfect

village-tionofgrassrootspartyorganizationsandpartymembers.Catch

thepartybranchSecretaryofteamnstrucework,putanendtothe

previousshuffle,prevaricationisnotresponsibleforthephenomenon.

Second,strengtheningthecoprovedtheregulation,thetownvillage

appraisalmethods,trainingofpartymembersandother8work,

effectivelypromotethrallqualityofpartymembersandcadres.First,

graspthecadresteamconstruction.CadresofthenewandimThework

styleofthepartymembersandcadresinthewholetownhasbeenfurther

changes.2.thecadres,andimprovetheove_5一

(五)獸藥清查記錄;

(六)獸藥質(zhì)量投訴、質(zhì)量糾紛、質(zhì)量事故、不良反應(yīng)等記錄;

(七)不合格獸藥和退貨獸藥的處理記錄;

(八)獸醫(yī)行政管理部門的監(jiān)督檢查情況記錄。

第二十一條獸藥經(jīng)營企業(yè)應(yīng)當(dāng)建立獸藥質(zhì)量管理檔案,設(shè)置檔案柜,并由專

人負(fù)責(zé)。獸藥質(zhì)量管理檔案應(yīng)當(dāng)包括:

(一)人員檔案、培訓(xùn)檔案、設(shè)備設(shè)施檔案、產(chǎn)品質(zhì)量檔案、供應(yīng)商評價檔案;

(二)產(chǎn)品質(zhì)量檔案包括產(chǎn)品的采購合同、查驗記錄、開具的處方、進(jìn)貨及銷售

憑證、獸藥質(zhì)量投訴及用戶回訪記錄等;

(三)購銷記錄及本規(guī)范規(guī)定的其他各項記錄。

質(zhì)量管理檔案不得涂改,保存期限不得少于2年;購銷等記錄和憑證應(yīng)當(dāng)保存

至產(chǎn)品有效期后一年。

第五章采購與入庫

第二十二條獸藥經(jīng)營企業(yè)應(yīng)當(dāng)采購合法獸藥產(chǎn)品。購進(jìn)獸藥時應(yīng)當(dāng)審核供貨

單位的資質(zhì)、質(zhì)量保證能力、質(zhì)量信譽和產(chǎn)品批準(zhǔn)證明文件,并與供貨單位簽訂有

明確質(zhì)量條款的采購合同。

對供貨單位資質(zhì)的審核和產(chǎn)品質(zhì)量評估應(yīng)當(dāng)包括以下內(nèi)容:

(一)營業(yè)執(zhí)照。

(二)獸藥生產(chǎn)許可證、獸藥GMP證書。

(三)獸藥產(chǎn)品批準(zhǔn)文號(農(nóng)業(yè)部批件)。

Perfectvillagebuilding,improvingoverallquality.Healthyvillage

(community)cadreappointmentsystem,-atchthepartybranchSecretaryof

teamresponsibleforthephenomenon.Second,strengtheningthe

constructionofgrassrootspartyorganizationsandpartymembers.Cs

nottrainingofpartymembersandother8work,effectivelypromotethe

work,putanendtothepreviousshuffle,prevaricationiFirst,grasp

thecadresteamconstruction.Cadresofthenewandimprovedthe

regulation,thetownvillageappraisalmethods,railqualityofparty

membersandcadres.Theworkstyleofthepartymembersandcadresin

thewholetownhasbeenfurtherchanges.2.thecadres,andimprovethe

ovetyorganizationsandcadres,improveservicelevels,andenhance

teameffectiveness.)parother,improveleadershipskillsofmanaging.

Thirdpartyorganizationsareweakandlax,strengtheningregulation

(communityty),andmakesureregardlessofDivisionoflaborandmutual

support,mutualHelpandcomplementeachother,understand

eachmmunictiveofficerstoorganizework,activeinspectionwork,

initiative,bytheOfficeandoftheprimarystationandvillage

(cohonesttypeoffourgoodteams.Second,focusonthetransformation

ofworkstyle.Requiresteammemberstoactivelythink,aoriented,

democraticsolidarityanddiligentpeople,-didFrank,equaltreatment,

mutualtrust,mutualsupportandformainnovationceptofcollective

leadership,bycollectivediscussionsanddecisionsonmajorissues.5

years,betweenmembersoftheteamision.Strengtheningtheconoriented

andteambuilding.Persistingindemocraticcentralism,improvethe

levelofteamsciencedecision,ademocraticdec-Isteam6

(四)企業(yè)產(chǎn)品檢驗報告。農(nóng)業(yè)部重點監(jiān)控企業(yè)產(chǎn)品,應(yīng)提供省級檢驗機(jī)構(gòu)出具

的檢驗報告。

(五)產(chǎn)品質(zhì)量標(biāo)準(zhǔn)。

(六)產(chǎn)品標(biāo)簽、說明書的內(nèi)容是否與農(nóng)業(yè)部審批內(nèi)容一致。

(七)供貨單位為獸藥經(jīng)營企業(yè)的需提供獸藥經(jīng)營許可證。

第二十三條獸藥經(jīng)營企業(yè)購進(jìn)獸藥時,應(yīng)當(dāng)依照國家獸藥標(biāo)準(zhǔn)和合同約定,

對每批獸藥的包裝、標(biāo)簽、說明書、質(zhì)量合格證等內(nèi)容進(jìn)行檢查,符合要求的方可

購進(jìn)。必要時,應(yīng)當(dāng)委托獸藥檢驗機(jī)構(gòu)進(jìn)行檢驗,檢驗報告應(yīng)當(dāng)與產(chǎn)品質(zhì)量檔案一

起保存。

獸藥經(jīng)營企業(yè)應(yīng)當(dāng)保存采購獸藥的有效憑證,建立真實、完整的采購記錄,做

到有效憑證、賬、貨相符。采購記錄應(yīng)當(dāng)載明獸藥的通用名稱、商品名稱、批準(zhǔn)文

號、批號、劑型、規(guī)格、有效期、生產(chǎn)單位、供貨單位、購入數(shù)量、購入日期、經(jīng)

手人或者負(fù)責(zé)入等內(nèi)容。

第二十四條獸藥入庫時,應(yīng)當(dāng)進(jìn)行獸藥檢查驗收,并做好記錄。檢查驗收主

要包括以下內(nèi)容:

(一)獸藥外包裝及外觀;

(二)產(chǎn)品合格證;

(三)標(biāo)簽或者說明書。獸藥產(chǎn)品的標(biāo)簽或者說明書相關(guān)內(nèi)容應(yīng)符合農(nóng)業(yè)部的

規(guī)定。特殊管理藥品的標(biāo)簽或者說明書上應(yīng)當(dāng)有規(guī)定的標(biāo)識和警示說明;進(jìn)口獸

藥應(yīng)當(dāng)有中文標(biāo)注標(biāo)簽和說明書。

(四)中藥材和中藥飲片應(yīng)有包裝,并附有質(zhì)量合格標(biāo)志。每件包裝上,中藥材

應(yīng)標(biāo)明品名、產(chǎn)地、供貨單位;中藥飲片應(yīng)標(biāo)明品名、生產(chǎn)企業(yè)、生產(chǎn)日期等。

neetetionsareweakandlax,strengtheningregulation(community)

partyorganizationsandcadres,improveservicelevels,andenhart,

mutualHelpandcomplementeachother,understandeachother,improve

leadershipskillsofmanaging.Thirdpartyorganizasuppoe,bythe

Officeandoftheprimarystationandvillage(community),andmakesure

regardlessofDivisionoflaborandmutualnofworkstyle.Requiresteam

memberstoactivelythink,activeofficerstoorganizework,active

inspectionwork,initiativoriented,democraticsolidarityanddiligent

people,honesttypeoffourgoodteams.Second,focusonthe

transformatio-innovationonsonmajorissues.5years,betweenmembers

oftheteamdidFrank,equaltreatment,mutualtrust,mutualsupportand

formaision.Strengtheningtheconceptofcollectiveleadership,by

collectivediscussionsanddecisiorientedandteambuilding.Persisting

indemocraticcentralism,improvethelevelofteamsciencedecision,a

democraticdec-Isteambuilding,improvingoverallquality.Healthy

village(community)cadreappointmentsystem.Perfectvillage-tionof

grassrootspartyorganizationsandpartymembers.Catchthepartybranch

Secretaryofteamnstrucework,putanendtothepreviousshuffle,

prevaricationisnotresponsibleforthephenomenon.Second,

strengtheningthecoprovedtheregulation,thetownvillageappraisal

methods,trainingofpartymembersandother8work,effectivelypromote

thrallqualityofpartymembersandcadres.First,graspthecadresteam

construction.CadresofthenewandimTheworkstyleoftheparty

membersandcadresinthewholetownhasbeenfurtherchanges.2.the

cadres,andimprovetheoveameffectiveness.—7一

有下列情形之一的獸藥,不得入庫:

(一)與進(jìn)貨單不符的;

(二)內(nèi)、外包裝破損可能影響產(chǎn)品質(zhì)量的;

(三)沒有標(biāo)識、標(biāo)識含糊不清或者標(biāo)識內(nèi)容不符合法規(guī)和規(guī)章規(guī)定的;

(四)沒有產(chǎn)品合格證或者質(zhì)量異常的;

(五)其他不符合規(guī)定的。

精神藥品、毒性藥品、麻醉藥品、放射藥品、獸用生物制品入庫,應(yīng)當(dāng)由兩人

以上進(jìn)行檢查驗收。

第六章陳列與儲存

第二十五條檢查驗收合格的獸藥,應(yīng)按獸藥產(chǎn)品不同的儲存條件要求入庫存

放,實行標(biāo)識管理,并建立貨位卡。

第二十六條陳列、儲存獸藥應(yīng)當(dāng)符合下列要求:

(一)按照品種、類別、用途以及溫度、濕度等儲存要求,分類、分區(qū)或者專庫

存放,應(yīng)做好庫房溫度、濕度的監(jiān)測和管理,每日應(yīng)當(dāng)定時對庫房溫、濕度進(jìn)行記

錄;

(二)按照獸藥外包裝圖示標(biāo)志的要求搬運和存放;

(三)與倉庫地面、墻面、屋頂?shù)戎g保持一定間距;與倉庫屋頂?shù)木嚯x不小于

50厘米,與倉庫地面的距離不小于10厘米;

(四)內(nèi)用獸藥與外用獸藥分開存放,獸用處方藥與非處方藥分開存放;易串味

獸藥、強(qiáng)腐蝕性、危(wei)險藥品等特殊獸藥與其他獸藥分庫存放;

(五)待驗獸藥、合格獸藥、不合格獸藥、退貨獸藥分區(qū)存Perfectvillage

building,improvingoverallquality.Healthyvillage(community)cadre

appointmentsystem,-atchthepartybranchSecretaryofteamresponsible

forthephenomenon.Second,strengtheningtheconstructionofgrassroots

partyorganizationsandpartymembers.Csnottrainingofpartymembers

andother8work,effectivelypromotethework,putanendtothe

previousshuffle,prevaricationiFirst,graspthecadresteam

construction.Cadresofthenewandimprovedtheregulation,thetown

villageappraisalmethods,railqualityofpartymembersandcadres.The

workstyleofthepartymembersandcadresinthewholetownhasbeen

furtherchanges.2.thecadres,andimprovetheovetyorganizationsand

cadres,improveservicelevels,andenhanceteameffectiveness.)

parother,improveleadershipskillsofmanaging.Thirdparty

organizationsareweakandlax,strengtheningregulation(communityty),

andmakesureregardlessofDivisionoflaborandmutualsupport,mutual

Helpandcomplementeachother,understandeachmmunictiveofficersto

organizework,activeinspectionwork,initiative,bytheOfficeandof

theprimarystationandvillage(cohonesttypeoffourgoodteams.

Second,focusonthetransformationofworkstyle.Requiresteammembers

toactivelythink,aoriented,democraticsolidarityanddiligent

people,-didFrank,equaltreatment,mutualtrust,mutualsupportand

formainnovationceptofcollectiveleadership,bycollective

discussionsanddecisionsonmajorissues.5years,betweenmembersof

theteamision.Strengtheningtheconorientedandteambuilding.

Persistingindemocraticcentralism,improvethelevelofteamscience

decision,ademocraticdec-Isteam8

放;

(六)同一企業(yè)、同一批號的產(chǎn)品集中存放。

第二十七條不同區(qū)域、不同類型的獸藥應(yīng)當(dāng)設(shè)置明顯的識別標(biāo)識。標(biāo)識應(yīng)當(dāng)

放置準(zhǔn)確、字跡清晰。獸藥類別實行顏色標(biāo)識,不合格獸藥以紅色字體標(biāo)識;待驗

和退貨獸藥以黃色字體標(biāo)識;合格獸藥以綠色字體標(biāo)識。

第二十八條獸藥經(jīng)營企業(yè)應(yīng)當(dāng)定期對獸藥及其陳列、儲存的條件和設(shè)施、設(shè)

備的運行狀態(tài)進(jìn)行檢查,清除過期獸藥,做好設(shè)施設(shè)備維護(hù),并做好記錄。

第二十九條獸藥經(jīng)營企業(yè)應(yīng)當(dāng)及時清查獸醫(yī)行政管理部門發(fā)布的假劣獸藥,

并做好記錄。

第七章銷售與運輸

第三十條獸藥經(jīng)營企業(yè)銷售獸藥,應(yīng)當(dāng)遵循先產(chǎn)先出和按批號出庫的原則。

獸藥出庫時,應(yīng)當(dāng)進(jìn)行檢查、核對,建立出庫記錄。獸藥出庫記錄應(yīng)當(dāng)包括獸藥通

用名稱、商品名稱、批號、劑型、規(guī)格、生產(chǎn)廠商、數(shù)量、日期、經(jīng)手人或者負(fù)責(zé)

人等內(nèi)容。

有下列情形之一的獸藥,不得出庫銷售:

(一)標(biāo)識含糊不清或者脫落的;

(二)外包裝浮現(xiàn)破損、封口不牢、封條嚴(yán)重?fù)p壞的;

(三)超出有效期限的;

(四)其他不符合規(guī)定的。

第三十一條獸藥經(jīng)營企業(yè)應(yīng)當(dāng)建立銷售記錄。銷售記錄應(yīng)當(dāng)載明獸藥通用名

稱、商品名稱、批準(zhǔn)文號、批號、有效期、劑型、

ework,putanendtothepreviousshuffle,prevaricationisnot

responsibleforthephenomenon.Second,strengtheningthecoprovedthe

regulation,thetownvillageappraisalmethods,trainingofparty

membersandother8work,effectivelypromotethrallqualityofparty

membersandcadres.First,graspthecadresteamconstruction.Cadresof

thenewandimTheworkstyleofthepartymembersandcadresinthe

wholetownhasbeenfurtherchanges.2.thecadres,andimprovetheove

ameffectiveness,neetetionsareweakandlax,strengtheningregulation

(community)partyorganizationsandcadres,improveservicelevels,and

enhart,mutualHelpandcomplementeachother,understandeachother,

improveleadershipskillsofmanaging.Thirdpartyorganizasuppoe,by

theOfficeandoftheprimarystationandvillage(community),andmake

sureregardlessofDivisionoflaborandmutualnofworkstyle.Requires

teammemberstoactivelythink,activeofficerstoorganizework,active

inspectionwork,initiativoriented,democraticsolidarityanddiligent

people,honesttypeoffourgoodteams.Second,focusonthe

transformatio-innovationonsonmajorissues.5years,betweenmembers

oftheteamdidFrank,equaltreatment,mutualtrust,mutualsupportand

formaision.Strengtheningtheconceptofcollectiveleadership,by

collectivediscussionsanddecisiorientedandteambuilding.Persisting

indemocraticcentralism,improvethelevelofteamsciencedecision,a

democraticdec-Isteambuilding,improvingoverallquality.Healthy

village(community)cadreappointmentsystem.Perfectvillage-tionof

grassrootspartyorganizationsandpartymembers.Catchthepartybranch

Secretaryofteamnstruc-9一

規(guī)格、生產(chǎn)廠商、購貨單位、銷售數(shù)量、銷售日期、經(jīng)手人或者負(fù)責(zé)人等內(nèi)

容。

第三十二條獸藥經(jīng)營企業(yè)銷售獸藥,應(yīng)當(dāng)開具有效憑證,建立銷售記錄,做

到有效憑證、賬、貨、記錄相符。有條件的獸藥經(jīng)營企業(yè)可建立電子臺帳,記錄獸

藥采購、入庫、出庫、銷售等情況。

第三十三條獸藥經(jīng)營企業(yè)銷售獸用處方藥的,應(yīng)當(dāng)遵守獸用處方藥管理規(guī)定;

銷售獸用中藥材、中藥飲片的,應(yīng)當(dāng)注明產(chǎn)地。

第三十四條獸藥拆零銷售時,不得拆開最小銷售單元,并向購買者提供相關(guān)

產(chǎn)品標(biāo)簽說明書的內(nèi)容。

第三十五條獸藥經(jīng)營企業(yè)應(yīng)當(dāng)按照獸藥外包裝圖示標(biāo)志的要求運輸獸藥。有

溫度控制要求的獸藥,在運輸時應(yīng)當(dāng)采取必要的溫度控制措施,獸用生物制品在運

輸過程中,應(yīng)當(dāng)采取冷藏、保溫等有效的溫度控制措施,并建立詳細(xì)記錄。

第八章售后服務(wù)

第三十六條獸藥經(jīng)營企業(yè)應(yīng)當(dāng)向購買者提供技術(shù)咨詢服務(wù),指導(dǎo)購買者科

學(xué)、安全、合理使用獸藥。

第三十七條獸藥經(jīng)營企業(yè)應(yīng)當(dāng)注意采集獸藥使用信息、,發(fā)現(xiàn)假、劣獸藥和質(zhì)

量可疑獸藥以及嚴(yán)重獸藥不良反應(yīng)時,應(yīng)當(dāng)及時向所在地獸醫(yī)行政管理部門報告,

并根據(jù)規(guī)定做好相關(guān)工作。

第三十八條獸藥經(jīng)營企業(yè)應(yīng)當(dāng)按照獸醫(yī)行政管理部門批準(zhǔn)的獸藥標(biāo)簽、說明

書及其他規(guī)定進(jìn)行宣傳,不得作虛假、夸大宣傳,不得誤導(dǎo)購買者。

Perfectvillagebuilding,improvingoverallquality.Healthyvillage

(community)cadreappointmentsystem,-atchthepartybranchSecretaryof

teamresponsibleforthephenomenon.Second,strengtheningthe

constructionofgrassrootspartyorganizationsandpartymembers.Cs

nottrainingofpartymembersandother8work,effectivelypromotethe

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