wanguofang
GSP是《药品经营质量管理规范》的英文缩写，是药品经营企业统一的质量管理准则。药品经营企业应在药品监督管理部门规定的时间内达到GSP要求，并通过认证取得认证证书。GSP是英文Good Supply Practice的缩写，意即良好供应规范，是控制医药商品流通环节所有可能发生质量事故的因素从而防止质量事故发生的一整套管理程序，医药商品在其生产、经营和销售的全过程中，由于内外因素作用，随时都有可能发生质量问题，必须在所有这些环节上采取严格措施，才能从根本上保证医药商品质量。因此，许多国家制定了一系列法规来保证药品质量，在实验室阶段实行GLP，新药临床阶段实行GCP，在医药商品使用过程中实施GUP，GSP是这一系列控制中十分重要的一环。我国的第一部GSP是1984年6月由中国医药公司发布的《医药商品质量管理规范》，经过若干年试行后进行了系统修改，于1992年3月由国家医药管理局再次发布，成为我国的第二部GSP。我国现行GSP是2000年4月30日由国家药品监督管理局发布的，自2000年7月1日起施行。我国现行GSP与前两部GSP具有一定的历史联系和传承关系，但是又具有自己鲜明的特点：1. 现行GSP是国家药品监督管理局发布的一部在推行上具有强制性的行政规章，是我国第一部纳入法的范畴的GSP。过去的GSP是由国有主渠道的上级管理部门或医药行业主管部门发布的，具有明显的行业管理色彩，仅仅是一部推荐性的行业管理标准。2. 现行GSP管理的商品范围变为与国际接轨，与《药品管理法》管理范围完全一致的药品。在计划经济条件下由于医药商业部门存在着医药商业和药材商业两大系统，GSP由医药行业主管部门制定，自然而然地将GSP的管理范围确定为药品、医疗器械、化学试剂和玻璃仪器四大类医药商品。与国际惯例相比，一方面多出了后三类非药品的医药商品，一方面在药品的范围内又不能涵盖全部药品（即不包括中药）。后来国家中医药管理局也曾制定过中药的GSP及其验收细则，但是几乎没有推行开来。由国家药品监督管理局发布的GSP将其管理范围变为单纯而又外延完整的药品，既与国际上GSP接轨，又与《药品管理法》中的药品概念完全一致。GSP的中文名称由《医药商品质量管理规范》变为《药品经营质量管理规范》。3. 现行GSP在文件结构上对药品批发和药品零售的质量要求分别设章表述，便于实际执行。以往的GSP对药品批发和零售没有分别要求，给实际执行带来了一些概念上的模糊和操作上的不便。4. 现行GSP更充分地吸收了现代质量管理学的理论成果，特别是对药品经营企业提出了建立质量体系，并使之有效运行的基本要求。在结构上将质量体系组成要素与药品经营过程密切结合起来，行文脉络非常清晰流畅。5. 现行GSP在具体管理内容上作了一些大胆的取舍，去掉了一些不切实际的要求，使之更具有实际指导意义。比如，果断删掉了原GSP中"综合性质量管理"（TQC）的有关内容。严格讲，TQC的管理范围要比GSP大得多，且完全包含了GSP，在GSP中要求推行TQC是不合逻辑的。同时，GSP是一个具体的管理标准，而TQC是一套管理理论和方法，在具体管理标准中硬性推行一种管理理论和方法，也不十分妥当。在"舍"的同时，也新"取"了一些非常切合实际需要的要求，比如关于"药品直调"的有关要求。6. 现行GSP与一些新发布的药品管理行政规章进行了较好的衔接。比如体现了"处方药与非处方药分类管理办法"、"药品流通监督管理办法（暂行）"、 "进口药品管理办法"等行政规章的有关管理要求。7. 现行GSP的监督实施主体成为药品行政执法部门，确保了GSP在全社会药品经营企业中全面推行。过去的GSP虽然要求在所有药品经营企业中推行，但由于监督实施的手段不力，只在国有药品经营企业得到了一定程度的推行，现行GSP由药品监督管理部门监督实施，完全可以确保其在全社会药品经营企业中全面推行。此外，推行GSP的方式也由过去搞GSP合格企业和达标企业变为实行更加科学、规范的GSP认证制度。8. 现行GSP是药品市场准入的一道技术壁垒。为加快推行GSP和体现推行GSP的强制性，推行GSP将与药品经营企业的经营资格确认结合起来，GSP已经成为衡量一个持证药品经营企业是否具有继续经营药品资格的一道硬杠杆，成为药品市场准入的一道技术壁垒。由药品监督管理部门组织开展的药品经营企业换证工作所采用的换证验收标准，实际上就是实施GSP的一个最低标准。根据国家药品监督管理局的部署，凡通过本次换证的药品经营企业，将在3～5年时间内进行GSP认证，未能取得GSP认证的企业，在下一轮药品经营企业换证时将取消其经营药品的资格。因此，推行GSP对改变目前药品经营企业过多过滥，药品经营秩序混乱的现状，促进药品经营企业提高管理水平，促进药品经营行业的经济结构调整将发挥重要作用。
新驰销售一部
9, electrical control system1, general requirementsa, electrical control of centralized control by way of partition, which is based pre-treatment, painting, hanging chain, electrophoresis and control cabinet after washing, drying and curing control cabinet.b, distribution: a distribution by the user is responsible for the secondary distribution by the supplier is responsible.c, electrophoretic control cabinet with all the electrical appliances on / off switch, the working status indicator.d, the system alarm: When the device during operation, once the abnormal condition, alarm system automatically starts and the form of audio prompts field staff which sets an equipment failure and lead to exclusion.e, all operating positions with tight stop button, and ensure that in case of emergency, the emergency stop line of work, to prevent major accidents occur.f, other countries did not state Department meet the latest standards.2, the specific way of implementing the control cabineta, electrophoresis, and after the flushing control cabinet: Electrophoresis silicon rectifier input voltage 380V, 50Hz three-phase. Rectifier output voltage: DC 0-250V, current adjustable DC 0-250A.b, hanging chain conveyor system, and Spray control cabinet: power lines and control lines separately from the installation, all the operator position with stop / start button, hanging chain, designed to run alarm bells across the board.c, control cabinet drying: the temperature of each control point (such as oven temperature) of the temperature measurement and control functions, oven temperature control precision was ± 5 ℃. Motor load and temperature gauge, etc. had trouble with sound, light alarm, and can find fault processing.3, the reliability measures1), the use of advanced technology in design.2), focusing on temperature and amount of temperature measurement point probe using the backup volume.3), a full set of equipment, electrical components used internally designated product manufacturers.12, painting line installation inspection requirements related to(1), the former treatment plant1. Appearance: structure consistent with a crisp, look no mechanical bumps, the whole surface smooth, uniform color.2. Performance: A. processing parameters required to meet the equipment, advanced technology, reasonable structure, easy maintenance, emissions up to the national standard.B. The spray pump, filtration devices running stable.C. The chamber body, tank, piping and equipment for all systems without leakage.D. Equipment Operation Noise ≤ 85dB.2. Performance: A. Run to meet the technological requirements, speed range 0.5-2.5m/min, to meet the production line speed.1. Appearance: smooth surface, uniform color.2. Performance: A. meet the equipment requirements process parameters.B. adjustable temperature control, automatic constant.C. drying the workpiece, the temperature is not more than ± 5 ℃.D. heating system uses natural gas heating.E. insulation using bulk density 100Kg/m3 quality rock wool, insulation thickness of 150mm.(3) paint spray system1. Appearance: reasonable structure, tight beat, the whole formation, no mechanical bumps, color uniform.2. Performance: A. meet the equipment requirements process parameters.B. mist treatment system is stable.C. equipment run Noise ≤ 85dB.(4) leveling Room1. Appearance: reasonable structure, compact, overall smooth, no mechanical bumps, color uniform.2. Performance: A. meet the equipment requirements process parameters.B. emission device with the top.(5) Cathode electrophoresis system1. Appearance: reasonable structure, compact, overall smooth, no mechanical bumps, color uniform.2. Performance: A. meet the equipment requirements process parameters.B. superior performance electrophoretic paint equipment, coating thickness.C. equipment run Noise ≤ 85dB.(6) hanging conveyor1. Appearance: standard XT100 type, appearance, color and follow the regulations.(2), drying ovenB. catenary run smoothly, without any crawling chattering.(7) electrical control systemAcceptance and implementation details of specific projects, in accordance with the electrical control system design requirements.(8) Acceptance of the coating line industry and business-related reference standards, the final meet customer requirements.13, coating equipment engineering acceptance documents1, assembly diagram2, base map3, electrical schematics4, operation manuals5, purchased parts certificate14, coating line technical service and after-sales service content and measures (limited to domestic)1, B Party is responsible for providing instructions and the related software information.2, the product warranty period of one year, during the warranty period, the product components, such as quality problems, unless Party A human responsibility, Party B is responsible for repairing.3, regular visits to customers to help them solve equipment related issues.4, B to the equipment provided technical guidance services.5, B as user training posts coating line operator, so that trainers can grasp the operation, adjustment and exclusion of the basic fault capacity.
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