中新网2月19日电 据国家食品药品监管局网站消息，近日，新修订《药品经营质量管理规范》(以下简称药品GSP)经卫生部部务会通过并正式发布，将于2013年6月1日起正式实施。

February 19, according to the state food and drug supervision bureau website news,recently,The new revised[The quality control standard for pharmaceutical business](Hereinafter referred to as the "drug GSP)The ministry of health issued a formal and BuWuHui through,On June 1, 2013 the formal implementation.

　　药品GSP的修订是中国药品流通监管政策的一次较大调整，是对药品经营活动所应当具备的条件和规范要求的一次较大提升。与现行规范相比，新修订药品GSP对企业经营质量管理要求明显提高，有效增强了流通环节药品质量风险控制能力。

Drug GSP revision is Chinese medicine circulation regulatory policy a greater adjustment,Is the drug operating activities shall meet the conditions and requirements of a large ascension.Compared with the current specification,The new revised drug GSP for enterprise management quality management requirements obviously improved,Effective enhance the circulation link drug quality risk control ability.

　　此次修订明确了“全面推进一项管理手段、强化两个重点环节、突破三个难点问题”的目标。一项管理手段就是实施企业计算机管理信息系统，两个重点环节就是药品购销渠道和仓储温湿度控制，三个难点就是票据管理、冷链管理和药品运输。

The revision made clear"Promote a management method/Strengthen the two key links/Break through three difficult problem"goal.A management method is to carry out enterprise computer management information system,Two key link is drug distribution channels and storage temperature and humidity control,Three difficulties is bill management/Cold chain management and drug transport.

　　修订后的药品GSP共4章，包括总则、药品批发的质量管理、药品零售的质量管理、附则，共计187条。新修订药品GSP集现行药品GSP及其实施细则为一体，增加了许多新的管理内容。如吸收了供应链管理的观念；增加了计算机信息化管理、仓储温湿度自动监测、药品冷链管理等管理要求；引入了质量风险管理、体系内审、设备验证等新的管理理念和方法。新修订药品GSP按照完善质量管理体系的要求，从药品经营企业的人员、机构、设施设备、体系文件等质量管理要素各个方面，对采购、验收、储存、养护、销售、运输、售后管理等环节都做出了新的规定。

The revised drug GSP in chapter 4,Including general principles/Pharmaceutical wholesale quality management/Drug retail quality management/Supplementary provisions,A total of 187.The new revised drug GSP set current drug GSP and its detailed implementation rules as a whole,Increased a lot of new management content.Such as absorbed the concept of supply chain management;Increase the computer information management/Storage temperature and humidity automatic monitoring/Drugs cold chain management requirements;Introducing the quality risk management/System internal audit/Equipment, validation and so on the new management ideas and methods.The new revised drug GSP according to perfect quality management system requirements,From drug management enterprise personnel/institutions/facilities/System document management factors such as quality aspects,To purchase/acceptance/storage/curing/sales/transport/Service management, and other areas have made the new regulations.

　　新修订药品GSP全面提升了企业经营的软硬件标准和要求，在保障药品质量的同时，也提高了市场准入门槛，有助于抑制企业低水平重复，促进行业结构调整，提高市场集中度。软件方面，新修订药品GSP明确要求企业建立质量管理体系，设立质量管理部门或配备质量管理人员，并对质量管理制度、岗位职责、操作规程、记录、凭证等一系列质量管理体系文件提出详细要求，并强调了文件的执行和实效；提高了企业负责人、质量负责人、质量管理部门负责人以及质管、验收、养护等岗位人员的资质要求。硬件方面，新修订药品GSP全面推行计算机信息化管理，着重规定计算机管理的设施、网络环境、数据库及应用软件功能要求；明确规定企业应当对药品仓库采用温湿度自动监测系统，对仓储环境实施持续、有效的实时监测；对储存、运输冷藏、冷冻药品要求配备特定的设施设备。

The new revised drug GSP comprehensive upgrade of the enterprise management software and hardware standards and requirements,In ensuring the quality of drugs at the same time,Also improve the market access threshold,Help to curb enterprise low level repeated,To promote the industry structure adjustment,Improve the market concentration.software,The new revised drug GSP clear requests the enterprise to set up quality management system,Set up quality management department or equipped with quality management personnel,And the quality management system/responsibilities/Operating procedures/record/Certificate and a series of quality management system document puts forward detailed requirements,And emphasizes the implementation and effectiveness of the file;Improved the responsible person of the enterprise/The quality assurance manager/Quality management department manager and quality control/acceptance/The maintenance of the post personnel qualification requirements.hardware,The new revised drug GSP the full implementation of the computer information management,Regulations on the management of computer facilities/Network environment/Database and application software functional requirements;Specific provision for the enterprise shall drug warehouse temperature and humidity automatic monitoring system,To the warehouse environment for implementation/Effective real-time monitoring;To store/Transport refrigeration/Frozen drug requirements equipped with specific facilities.

　　针对药品监管中的薄弱环节，新修订药品GSP增设了一系列新制度。针对药品经营行为不规范、购销渠道不清、票据管理混乱等问题，新修订药品GSP明确要求药品购销过程必须开具发票，出库运输药品必须有随货同行单(票)并在收货环节查验，物流活动要做到票、账、货相符，以达到规范药品经营行为，维护药品市场秩序的目的。针对委托第三方运输，新修订药品GSP要求委托方应当考察承运方的运输能力和相关质量保证条件，签订明确质量责任的委托协议，并要求通过记录实现运输过程的质量追踪，强化了企业质量责任意识，提高了风险控制能力。针对冷链管理，新修订药品GSP提高了对冷藏、冷冻药品的储运设施设备的要求，特别规定了此类药品在运输、收货等环节的交接程序和温度监测、跟踪、查验等要求，强化了高风险品种的质量保障能力。

According to the drug supervision of the weak link,The new revised drug GSP added a series of new system.According to the drug management behavior is not standard/Marketing channel is not clear/Bill management problems such as chaos,The new revised drug GSP clear requirements drug distribution process must draw up invoices,Outbound transportation drugs must have walked with cargo list(ticket)And in the receiving link inspection,Logistics activities to do ticket/account/Goods conform to,In order to achieve the standard drug management behavior,The purpose of maintaining the order of the pharmaceutical market.According to entrust a third party to transport,The new revised drug GSP requirements principal shall study the carrier shall transport capacity and related quality guarantee conditions,A clear quality responsibility of commitments,And demand through the record of the process to realize transportation quality tracking,To strengthen the enterprise quality responsibility consciousness,To improve the risk control ability.According to the cold chain management,The new revised drug GSP improve the cold storage/Frozen drug storage and transportation facilities equipment requirements,Special provisions for such drugs in transportation/Receiving and link handover procedures and temperature monitoring/tracking/Inspection requirements for,To strengthen the high-risk varieties of quality assurance ability.

　　新修订药品GSP与医改“十二五”规划及药品安全“十二五”规划等新政策紧密衔接。为落实医改“十二五”规划和药品安全“十二五”规划关于药品全品种全过程实施电子监管、保证药品可追溯的要求，新修订药品GSP规定了药品经营企业应当制定执行药品电子监管的制度，并对药品验收入库、出库、销售等环节的扫码和数据上传等操作提出具体要求。为配合药品安全“十二五”规划对执业药师配备的要求，新修订药品GSP规定了药品零售企业的法定代表人或企业负责人应当具备执业药师资格；企业应当按国家有关规定配备执业药师，负责处方审核，指导合理用药。

The new revised drug GSP and cure"1025"Planning and drug safety"1025"Planning the new policy tailgating.To carry out the reform"1025"Planning and drug safety"1025"Planning about drugs all varieties of implementation of the whole process of electronic supervision/To ensure drug traceability requirements,The new revised drug GSP stipulated the pharmaceutical trading enterprises shall formulate implementation drug electronic monitoring system,And the drug acceptance/outbound/Sales link and code and data upload and operation put forward specific requirements.In order to cooperate with the drug safety"1025"Planning for licensed pharmacists equipped with requirements,The new revised drug GSP stipulated drug retail enterprise legal representative or the responsible person of the enterprise shall have the qualification of licensed pharmacists;According to the relevant provisions of the state enterprise shall be equipped with licensed pharmacists,Responsible for prescription audit,Guide rational drug use.

　　国家食品药品监管局为新修订药品GSP实施设置了3年过渡期。到2016年规定期限后，对仍不能达到新修订药品GSP要求的企业，将依据《药品管理法》的有关规定停止其药品经营活动。国家食品药品监管局将及时出台具体实施步骤，严格监督实施新修订药品GSP，进一步加强药品经营质量管理，规范药品经营行为，切实保障公众用药安全有效。

State food and drug supervision bureau for the new revised drug GSP implement set up three years transition.To 2016 years after the specified time limit,Still can't meet the new revised drug GSP requirements of the enterprise,Will be based on[Drug administration law]Stop the relevant provisions of the pharmaceutical business activities.State food and drug supervision bureau will timely concrete implementation steps,Strictly implement the newly revised drug GSP,To further strengthen the quality control of pharmaceutical trading,Standard drug management behavior,To ensure the safe and effective drugs.