【正文】 以上藥品經(jīng)營質(zhì)量管理工作經(jīng)歷，能獨立解決經(jīng)營過程中的質(zhì)量問題。39*01901企業(yè)負責人應(yīng)當具有大學?？埔陨蠈W歷或者中級以上專業(yè)技術(shù)職稱；應(yīng)當經(jīng)過基本的藥學專業(yè)知識培訓，熟悉有關(guān)藥品管理的法律法規(guī)及本規(guī)范。3701718質(zhì)量管理部門應(yīng)當承擔其他應(yīng)當由質(zhì)量管理部門履行的職責。35*01716質(zhì)量管理部門應(yīng)當組織對被委托運輸?shù)某羞\方運輸條件和質(zhì)量保障能力的審查。33*01714質(zhì)量管理部門應(yīng)當組織質(zhì)量管理體系的內(nèi)審和風險評估。3101712質(zhì)量管理部門應(yīng)當負責藥品召回的管理。29*01710質(zhì)量管理部門應(yīng)當負責指導(dǎo)設(shè)定計算機系統(tǒng)質(zhì)量控制功能，負責計算機系統(tǒng)操作權(quán)限的審核和質(zhì)量管理基礎(chǔ)數(shù)據(jù)的建立及更新。2701708質(zhì)量管理部門應(yīng)當負責假劣藥品的報告。25*01706質(zhì)量管理部門應(yīng)當負責不合格藥品的確認，對不合格藥品的處理過程實施監(jiān)督。2301704質(zhì)量管理部門應(yīng)當負責質(zhì)量信息的收集和管理，并建立藥品質(zhì)量檔案。2101702質(zhì)量管理部門應(yīng)當組織制訂質(zhì)量管理體系文件，并指導(dǎo)、監(jiān)督文件的執(zhí)行。19*01602 企業(yè)質(zhì)量管理部門的職責不得由其他部門及人員履行。17*01501 企業(yè)質(zhì)量負責人應(yīng)當由企業(yè)高層管理人員擔任，全面負責藥品質(zhì)量管理工作，獨立履行職責，在企業(yè)內(nèi)部對藥品質(zhì)量管理具有裁決權(quán)。15*01302 企業(yè)應(yīng)當明確規(guī)定各組織機構(gòu)或者崗位的職責、權(quán)限及相互關(guān)系。13*01201 企業(yè)應(yīng)當全員參與質(zhì)量管理，各部門、崗位人員應(yīng)當正確理解并履行職責，承擔相應(yīng)的質(zhì)量責任。1101001 企業(yè)應(yīng)當采用前瞻或者回顧的方式，對藥品流通過程中的質(zhì)量風險進行評估、控制、溝通和審核。9*00802 企業(yè)應(yīng)當在質(zhì)量管理體系關(guān)鍵要素發(fā)生重大變化時，組織開展內(nèi)審。7*00701 企業(yè)質(zhì)量管理體系應(yīng)當與其經(jīng)營范圍和規(guī)模相適應(yīng),包括組織機構(gòu)、人員、設(shè)施設(shè)備、質(zhì)量管理體系文件及相應(yīng)的計算機系統(tǒng)等。500503企業(yè)應(yīng)當制定質(zhì)量管理體系文件，開展質(zhì)量策劃、質(zhì)量控制、質(zhì)量保證、質(zhì)量改進和質(zhì)量風險管理等活動。3質(zhì)量管理體系*00501企業(yè)應(yīng)當依據(jù)有關(guān)法律法規(guī)及本規(guī)范的要求建立質(zhì)量管理體系。第一部分 藥品批發(fā)企業(yè)一、《藥品經(jīng)營質(zhì)量管理規(guī)范》部分序號條款號檢查項目1總則**00401 藥品經(jīng)營企業(yè)應(yīng)當依法經(jīng)營。五、藥品零售連鎖企業(yè)總部及配送中心按照藥品批發(fā)企業(yè)檢查項目檢查，藥品零售連鎖企業(yè)門店按照藥品零售企業(yè)檢查項目檢查。四、本指導(dǎo)原則批發(fā)企業(yè)檢查項目共258項，其中嚴重缺陷項目（**）6項，主要缺陷項目（*）107項，一般缺陷項目145項。三、按照本指導(dǎo)原則進行檢查過程中，有關(guān)檢查項目應(yīng)當同時對照所對應(yīng)的附錄檢查內(nèi)容進行檢查。s political discipline problems. 2, in the implementation of the central authorities of the eight provisions. Improving research, improving research methods, but there are less grassroots units, primary firsthand an inadequate grasp of the problem, which is to be strengthened in the future. Second, construction, strictly in accordance with the provisions to streamline and improve the quality of meetings of the Conference. Third, streamlining file briefs, culture involves all aspects of propaganda and ideology, sometimes due to the practical needs of invention notifications, this area needs further藥品經(jīng)營質(zhì)量管理規(guī)范現(xiàn)場檢查指導(dǎo)原則說 明　　 一、為規(guī)范《藥品經(jīng)營質(zhì)量管理規(guī)范》檢查工作，確保檢查工作質(zhì)量，根據(jù)《藥品經(jīng)營質(zhì)量管理規(guī)范》，制定《藥品經(jīng)營質(zhì)量管理規(guī)范現(xiàn)場檢查指導(dǎo)原則》。s political disciplines. 　　Conscientiously abide by the party39。 according to the ...　Since the educational practice of the mass line of the party, himself seriously in the education, practical control central eight rules and opposing the four winds and practicing three Suns, and check the spirit of Jiao Yulu, ideology, solicit opinions based on outstanding problems checked swing, careful analysis and reflection. Will now check report is as follows: first, adherence to the party39。the principle of simplified EIA of construction projects in the region. In terms of land, linked to the implementation of urban and rural construction land increase and decrease, replacement indicators for priority areas project. Charges, into the projects of water, electricity, administrative charges and preferential policies. In the area of taxation, and settled in areas of industry and its production pany, within 5 years after the pletion of fiscal incentives to enterprises. In terms of financing, integration of land, tax, financial and other resources, and construct Government credit + business credit credit system, establishment of marketization, mercialization and modernization of the investment and financing platform。 effective Bankenterprise docking, encourages private capital into the Park, to raise industry development fund. 5, optimize the environment and service industries. To create policy lowlands, Highlands, integrity of service land, development land as the goal, to optimize the area under development environment. All administrative law enforcement departments to appoint a fulltime personnel stationed in areas dedicated to coordinating and solving problems associated with businesses in this sector. When there are substantial issues, sector leaders arranged to personally intervene, inperson, inperson push tangible area building a green light, easy line. To further reduce and standardize administrative examination and approval items, simplify examination and approval links, improve efficiency。s political discipline, eight in the central provision, change the style of the basic situation of 1, in pliance with the party39。s political discipline, abide by the Constitution and the rules and regulations of the party, in the political, ideological and maintain highly consistent with the CPC Central Committee on the action, there is no violation of the party39。二、應(yīng)當按照本指導(dǎo)原則中包含的檢查項目和所對應(yīng)的附錄檢查內(nèi)容，對藥品經(jīng)營企業(yè)實施《藥品經(jīng)營質(zhì)量管理規(guī)范》情況進行全面檢查。如果附錄檢查內(nèi)容檢查中存在任何不符合要求的情形，所對應(yīng)的檢查項目應(yīng)當判定為不符合要求。本指導(dǎo)原則零售企業(yè)檢查項目共180項，其中嚴重缺陷項目（**） 4項，主要缺陷項（*）58 項，一般缺陷項118項。六、結(jié)果判定：檢查項目結(jié)果判定嚴重缺陷項目主要缺陷項目一般缺陷項目00≤20%通過檢查0020%~30%限期整改后復(fù)核檢查0＜10%＜20%≥1不通過檢查0≥10%0＜10%≥20%00≥30%注：缺陷項目比例數(shù)=對應(yīng)的缺陷項目中不符合項目數(shù)/（對應(yīng)缺陷項目總數(shù)對應(yīng)缺陷檢查項目合理缺項數(shù)）100%。2**00402 藥品經(jīng)營企業(yè)應(yīng)當堅持誠實守信，禁止任何虛假、欺騙行為。400502 企業(yè)應(yīng)當確定質(zhì)量方針。6*00601 企業(yè)制定的質(zhì)量方針文件應(yīng)當明確企業(yè)總的質(zhì)量目標和要求，并貫徹到藥品經(jīng)營活動的全過程。8*00801 企業(yè)應(yīng)當定期開展質(zhì)量管理體系內(nèi)審。10*00901 企業(yè)應(yīng)當對內(nèi)審的情況進行分析，依據(jù)分析結(jié)論制定相應(yīng)的質(zhì)量管理體系改進措施，不斷提高質(zhì)量控制水平，保證質(zhì)量管理體系持續(xù)有效運行。1201101 企業(yè)應(yīng)當對藥品供貨單位、購貨單位的質(zhì)量管理體系進行評價，確認其質(zhì)量保證能力和質(zhì)量信譽，必要時進行實地考察。14機構(gòu)和質(zhì)量管理職責*01301 企業(yè)應(yīng)當設(shè)立與其經(jīng)營活動和質(zhì)量管理相適應(yīng)的組織機構(gòu)或者崗位。16*01401 企業(yè)負責人是藥品質(zhì)量的主要責任人，全面負責企業(yè)日常管理，負責提供必要的條件，保證質(zhì)量管理部門和質(zhì)量管理人員有效履行職責，確保企業(yè)實現(xiàn)質(zhì)量目標并按照《藥品經(jīng)營質(zhì)量管理規(guī)范》（以下簡稱《規(guī)范》）要求經(jīng)營藥品。18*01601 企業(yè)應(yīng)當設(shè)立質(zhì)量管理部門，有效開展質(zhì)量管理工作。2001701質(zhì)量管理部門應(yīng)當督促相關(guān)部門和崗位人員執(zhí)行藥品管理的法律法規(guī)及《規(guī)范》的要求。22*01703質(zhì)量管理部門應(yīng)當負責對供貨單位和購貨單位的合法性、購進藥品的合法性以及供貨單位銷售人員、購貨單位采購人員的合法資格進行審核，并根據(jù)審核內(nèi)容的變化進行動態(tài)管理。24*01705質(zhì)量管理部門應(yīng)當負責藥品的驗收，指導(dǎo)并監(jiān)督藥品采購、儲存、養(yǎng)護、銷售、退貨、運輸?shù)拳h(huán)節(jié)的質(zhì)量管理工作。2601707質(zhì)量管理部門應(yīng)當負責藥品質(zhì)量投訴和質(zhì)量事故的調(diào)查、處理及報告。2801709質(zhì)量管理部門應(yīng)當負責藥品質(zhì)量查詢。30*01711質(zhì)量管理部門應(yīng)當組織驗證、校準相關(guān)設(shè)施設(shè)備。3201713質(zhì)量管理部門應(yīng)當負責藥品不良反應(yīng)的報告。3401715質(zhì)量管理部門應(yīng)當組織對藥品供貨單位及購貨單位質(zhì)量管理體系和服務(wù)質(zhì)量的考察和評價。3601717質(zhì)量管理部門應(yīng)當協(xié)助開展質(zhì)量管理教育和培訓。38人員與培訓01801 企業(yè)從事藥品經(jīng)營和質(zhì)量管理工作的人員，應(yīng)當符合有關(guān)法律法規(guī)及《規(guī)范》規(guī)定的資格要求，不得有相關(guān)法律法規(guī)禁止從業(yè)的情形。40*02001 企業(yè)質(zhì)量負責人應(yīng)當具有大學本科以上學歷、執(zhí)業(yè)藥師資格和3年以上藥品經(jīng)營質(zhì)量管理工作經(jīng)歷，在質(zhì)量管理工作中具備正確判斷和保障實施的能力。4202201企業(yè)應(yīng)當配備符合相關(guān)資格要求的質(zhì)量管理、驗收及養(yǎng)