oecd good laboratory practice (glp)中英文对照ppt版

OECD GLP Principles经济合作与发展组织GLP 原则,Suzhou Research-LeoLiu西山中科-刘振超,5. Test Systems试验系统,5.1 Physical/Chemical理化试验系统5.1.1Apparatus used for the generation of physical/chemical data should be suitably located and of appropriate design and adequate capacity.5.1.1用于生成理化数据的仪器应当经过合理的设计和安置，并且具有足够的能力。,5. Test Systems试验系统,5.1 Physical/Chemical理化试验系统5.1.2 The integrity of the physical/chemical test systems should be ensured.5.1.2应当保证理化试验系统的完整性。,5. Test Systems试验系统,5.2 Biological生物试验系统5.2.1 Proper conditions should be established and maintained for the storage, housing, handling and care of biological test systems, in order to ensure the quality of the data.5.2.1应当为生物试验系统提供合适的安置和饲养(培养)条件，以保证专题数据的质量。,5. Test Systems试验系统,5.2 Biological生物试验系统5.2.2 Newly received animal and plant test systems should be isolated until their health status has been evaluated. If any unusual mortality or morbidity occurs, this lot should not be used in studies and, when appropriate, should be humanely destroyed. At the experimental starting date of a study, test systems should be free of any disease or condition that might interfere with the purpose or conduct of the study. Test systems that become diseased or injured during the course of a study should be isolated and treated, if necessary to maintain the integrity of the study. Any diagnosis and treatment of any disease before or during a study should be recorded.,5. Test Systems试验系统,5.2 Biological生物试验系统5.2.2新接收的动植物试验系统应当隔离直到他们的健康状况得到评估。如果发生异常的发病率和死亡率，这个批次的试验系统不应当用于专题，合适时，进行人性化销毁。在试验开始时，试验系统不能带有（患有）会影响专题实施和试验目的的状态或疾病。如果在专题实施期间试验系统受伤或感染了这样疾病，该试验系统应当被隔离和治疗（如果是为了保持专题的完整性的目的）。在专题启动之前和专题实施阶段所进行的诊断和治疗都应当被记录。,5. Test Systems试验系统,5.2 Biological生物试验系统5.2.3 Records of source, date of arrival, and arrival condition of test systems should be maintained.5.2.3应当保留试验系统的来源、到达日期和到达时状态的记录。,5. Test Systems试验系统,5.2 Biological生物试验系统5.2.4 Biological test systems should be acclimatised to the test environment for an adequate period before the first administration or application of the test or reference item.5.2.4生物试验系统在首次给药（暴露）之前应当在试验环境里适应性饲养（培养）足够的时间。,5. Test Systems试验系统,5.2 Biological生物试验系统5.2.5All information needed to properly identify the test systems should appear on their housing or containers. Individual test systems that are to be removed from their housing or containers during the conduct of the study should bear appropriate identification, wherever possible.5.2.5需要用于明确标识试验系统的所有信息，应当在试验系统的饲养（培养）的笼具（容器）上出现。需要从笼具（或其他试验容器）里取出和放回的试验系统个体需要进行合理标识。,5. Test Systems试验系统,5.2 Biological生物试验系统5.2.6During use, housing or containers for test systems should be cleaned and sanitised at appropriate intervals. Any material that comes into contact with the test system should be free of contaminants at levels that would interfere with the study. Bedding for animals should be changed as required by sound husbandry practice. Use of pest control agents should be documented.5.2.6饲养（培养）容器应当以一定时间间隔清洁和消毒。与试验系统接触的物品所携带污染物的等级不应当会影响到专题（的质量和完整性）。垫料应当及时更换，以便保持动物的干爽和清洁。杀虫剂的使用应当被记录。,5. Test Systems试验系统,5.2 Biological生物试验系统5.2.7 Test systems used in field studi