标准品对照品管理程序2

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1、Innovation, the key is to play the leading role of innovation in the innovation of science and technology. We have placed at the core of the overall development of science and technology innovation Location and develop technology, branding, quality as the core competitive advantages of regional inno

2、vation, better use of the multiplier effect on economic development. To strengthen scientific and technological cooperation. Around the forest and mineral resources of the deep processing, exploitation of technical innovation to promote transfer, transformation, application and popularization of sci

3、entific and technological achievements. We should improve the system of science and technology. Thoroughly implement the Central stream of deepening the reform of science and technology programme and the province issued regulations on scientific and technological progress, promoting the regions scie

4、nce and technology enterprises three years action plan, optimize the allocation of scientific resources, maximum release innovation potential of science and technology, and strive to better enterprise in seed industry and beyond, and more new Board listing. Sought to improve science and technology p

5、rojects and administration. Strengthening science and technology innovation projects top design, and strive with national and provincial Thirteen-Five technology plans, actively seek national and provincial major science and technology projects, industrial projects and demonstration projects, suppor

6、ting science and technology enterprises to increase scientific and technological investment in research and development and technology, research and Development Center, forming a number of technologies and products with independent intellectual property rights. (Specific to the XX, we will continue

7、to do a good job in agricultural research and demonstration of County agriculture Park, rural agricultural demonstration base into full play the dual role of active counties to build cooperation with the provincial Agricultural University, introduction of advanced scientific research and experiments

8、 in promotion, promoting produce, learn, research development. Strengthening grass-roots agricultural technicians system construction and management to progressively increase the agricultural sensible quantities to build County XX County planting structure adjustment of agricultural technology-savvy

9、 experts. ), Third, we must strengthen human resources support. Talent is supporting the development of the first resource. Both the development of new industries, or corporate development requires talent as a lead. I was personnel structure characteristic of traditional forestry, professional and t

10、echnical personnel more than 85% for culture, education, health and forestry personnel, pure business managers is less than 12%, with the capability of research and development professionals is not enough 1%, talent as a whole cultural structure of structure and low level of developmentSOR/QA066-021

11、.目的:规范标准品、对照品的管理,确保检验结果的准确性及可追踪性。2.范围:标准品、对照品。3.责任者:QC负责人、检验员、标准品管理员。4.程序:4.1标准品及对照品4.1.1 定义4.1.1.1对照品、标准品系指用于鉴别、检查、含量测定的标准物质。4.1.1.2对照品/标准品分为一级对照品/标准品和二级对照品。一级对照品/标准品为购置的由中国药品生物制品检定所制备、标定和供应的对照品/标准品,如中国药典对照品/标准品,还包括其它国家/国际的对照品/标准品如USP对照品/标准品、EP对照品/标准品等。4.1.1.3二级对照品为工作对照品,是指在本实验室用一级对照品标定过的已知含量的,作对照品

12、用的原料药;或当该品种无一级对照品时,只能使用原料药标定含量后作为对照品使用。工作对照品可代替一级对照品用于样品检验。4.1.2 QC实验室应设对照品/标准品管理员,负责对照品/标准品的管理。管理员应具有一定药学或分析专业知识,熟悉对照品/标准品的性质和贮存条件。4.1.3对照品/标准品的采购4.1.3.1检验用对照品/标准品应到省药检所、中国药品生物制品检定所或其它法定单位购买。4.1.3.2采购时应尽量注明分子式、分子量及结构式,以免发生误购。4.1.3.3因特殊原因需要临时购买对照品/标准品时,经质管部经理批准后,对照品/标准品管理员可临时直接采购。4.1.4对照品/标准品的接收4.1.

13、4.1对照品/标准品到厂后,对照品/标准品管理员应检查外包装是否完好,封口是否严密,标签是否清晰、完好,复核与采购单是否一致。4.1.4.2对照品/标准品批号管理4.1.4.2.1一级对照品/标准品直接使用原批号。4.1.4.2.1二级对照品/标准品的批号按照分装日期确定,如2005年12月4日分装的对照品批号应为。4.1.5二级对照品的标定4.1.5.1化验室根据检验需要提出二级对照品申请,报质量管理部经理批准后,由QC化验室负责人和相关部门执行二级对照品的制备程序。4.1.5.2样品来源:如是由物控部购进的原料,则必须提供该单位的生产资质证明和该批的出厂报告单,以保证原料的合法来源;如是本

14、公司生产的原料,取该批样品适量,提供给相关部门进行精制。4.1.5.3接受标准:二级对照品含量应与一级对照品标示量相当,或符合有关标准要求。4.1.5.4二级对照品的标定4.1.5.4.1有药典对照品时在标定过程之前,采用药典所规定的各项测试,对自制样品与药典对照品进行直接分析比较。确定该样品已完全符合现有药典要求。自制对照品在用药典对照品标定后,符合4.1.5.3接受标准方可用做工作对照品。标定时,由两个检验员在不同时间分别称取三份样品平行测定,并计算结果、平均值与RSD%,其RSD%应所有参加本项检修的正式工应为专业从事电机检修,且通过技能鉴定合格的人员。临时工应熟悉相应的设备系统工作环境

15、,并且通过简单的技能培训合格,安规培训考试合格。Without leads, my transition would be struggling. To improve the talent mechanism. Recently, the Central Government issued a circular on opinions on deepening the reform of talent development system aimed at stimulating innovation to create the maximum of entrepreneurial acti

16、vity. We to actual research developed implement views of implementation approach, further perfect prefectural last year introduced of 19 article talent policy, to through flexible introduced talent, and joint construction development center, and cooperation established focus laboratory, measures solution local talent short problem, implementation technology results pricing shares, and equity option incentive, and Division, award ap

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