GLP(良好实验室规范).ppt

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1、1、整洁有序的实验室日常管理 GOOD HOUSEKEEPING PRACTICE2、安全规范 SAFETY PRACTICE3、符合专业要求的操作 GOOD OPERATIONAL PRACTICE4、纯净水 PURIFIED WATER5、标准物质 REFERENCE MATERIALS6、标准溶液 STANDARD SOLUTIONS7、留样 RETAINED SAMPLES8、实验室器皿的清洁 CLEANING OF LABORATORY WARE9、化学通风橱 FUME CUPBOARDS10、层流通风柜（超净工作台）LAMINAR FLOW HOODS11、实验室能力验证 LABO

2、RATORY PROFICIENCY TESTWork flow:A well organized laboratory should minimize the amount of backtracking and retracing of steps.工作流程：实验室的布置应合理有序，以有助于提高工作效率。Labs shall be kept clean and tidy and free from unnecessary clutter and equipment.实验室应保持清洁，整齐，不放置不需要的物品和仪器。All gangways,aisles and exits will be

3、free to allow easy access.通道，走廊和出口保持通畅。All equipment,glassware and other supporting instrumentation will be back in their proper place after use.所有仪器，玻璃器皿和辅助器具使用后应放加原处。A label will be placed on each cupboard and draw to identify its contents.橱柜和抽屉应有标识。Most chemicals in the laboratory are potentially

4、 hazardous,they shall be properly labeled and separately stored.化学品应分类存放，并按性质作危害性标识。Personnel will wear durable clothing that covers the arms,legs,torso and feet.Open-tode shoes and sandals will not be worn.实验室人员应穿着牢固的能遮盖手臂、腿、身体和脚的服装，不得穿着露趾鞋和拖鞋。A clean,fastened cotton laboratory coat will be worn.La

5、boratory coats will not be worn in refreshment areas or lunch rooms.应穿着紧身的棉质工作服，工作服不可穿进茶点休息区域或食堂。Eye protection will be worn unless the analyst can demonstrate that adequate protection is provided by other means.实验室应配备保护眼睛的设施，否则应配戴护眼镜。Each laboratory has dedicated hand washing facilities-including s

6、oap and paper towels.Hands are washed on entering the laboratory before starting analysis,and when entering and exiting the laboratory for lunch or going to the toilet.实验室应配备专用洗手设施-包括清洁剂和纸巾。进入实验室开始分析前，离开实验室进餐厅和由餐厅回实验室，或去洗手间均须洗手。Appropriate gloves are worn when handling substances that may be absorbe

7、d through the skin or that are corrosive,harmful or may irritate the analyst.处理易被皮肤吸收或腐蚀有害或刺激性的物质时应带适当的手套。Characters of chemicals,such as“Flammable”,“Corrosive”etc.shall be correctly identified and labeled.化学品的特性，如“易燃”，“腐蚀”等应正确标识。Cylinders shall be fixed and clearly labeled.钢瓶应清楚标识，并固定。Cuts and graz

8、es to the skin are adequately covered by suitable dressings.伤口和皮肤擦破处应适当地包扎敷裹。Personnel will not work in a laboratory alone.不可单独在实验室工作。Eating,drinking and smoking are prohibited in the laboratory at all times.任何时候均不得在实验室吃、喝和抽烟。Solvent bottles are always covered as they will readily absorb moisture an

9、d contaminants from the air.溶剂易吸收空气中的水分和污染物，溶剂瓶必须随时盖紧。A pipette will not be used to pipette directly from the bottle unless it is an automatic pipette.The remaining solvent is not returned to the stock bottle.It must be treated as waste.不可用移液管直接从瓶中移取溶剂或溶液，应倾倒入容器内移取，剩余溶剂不可倒回贮液瓶，应作废弃物处理。A spatula or s

10、poon will not be placed directly into the bottle for solids.The required quantity is decanted into another container from which the material will be retrieved.The remaining material will not be returned to stock bottle.It should be treated as waste.不可用刮勺或匙直接从瓶中取用固体试剂，应在另一容器中倾入所需量。剩余试剂不可倒回原容器，应作废弃物处理

11、。Laboratory personnel shall be made aware of their responsibilities in the use of suitable reagents,solvents,culture media,reference materials and laboratory ware in terms of the types of analysis they conduct.实验室人员应明确其有责任根据所进行的测试使用适合的试剂、溶剂、培养基、参照物和实验室器皿。Any possible contamination,including Leftover

12、s that has been returned to the containers.任何可能导致污染的操作，包括将取出未用完的试剂、溶剂、培养基、参照物放回容器，受影响的物质均应视为失效。INTEGRITY OF REAGENTSAll reagent containers shall be labeled and tightly closed.They shall bear the original label.所有试剂容器均应标识和盖紧。容器上的标贴必须为原标贴。INTEGRITY OF REAGENTSThe person responsible for the preparation

13、 of the reagent shall be identifiable either from the label or from records.试剂的配制人应在标贴上标识或在记录中写明。试剂的配制人应在标贴上标识或在记录中写明。Laboratory shall establish written procedures for preparation of reagent solutions and culture media.Records of such preparation shall be maintained.实验室应建立试剂溶液和培养基配制方法的文件。应保存配制记录。实验室

14、应建立试剂溶液和培养基配制方法的文件。应保存配制记录。Records for reagent solutions shall include measured weights and volume,burette readings,pH readings,calculation of standardization factor and solution concentration.试剂溶液配制记录应包括重量，体积，滴定管读数，试剂溶液配制记录应包括重量，体积，滴定管读数，PH读数标定因子的计算和溶读数标定因子的计算和溶液浓度。液浓度。The preparation record for cu

15、lture media shall include medium name,batch number,amount prepared,pH before and after autoclaving autoclave time and pressure.培养基的配制记录应包括名称、批号、配制量、压热锅处理前后的培养基的配制记录应包括名称、批号、配制量、压热锅处理前后的PH值，处理时值，处理时间和压力。间和压力。Where laboratory prepares its own media,the chemicals used for such preparation shall be veri

16、fied to be of the appropriate quality before use.如实验室自己制备培养基，使用前应确认所用化学品符合质量要求。如实验室自己制备培养基，使用前应确认所用化学品符合质量要求。“hazardous substance”shall be kept separately from other reagents and held in locked cabinets.危险物质应与其它试剂分别存放，并加锁。危险物质应与其它试剂分别存放，并加锁。Preparation And Storage Of Culture media培养基的制备和存储培养基的制备和存储Culture media must be prepared and stored at the specified temperature and under the specified conditions according to the manufacturers instructions or method requirements.Each lot of prepared or purc