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["附件1"]
["兽药非临床研究质量管理规范监督检查标准"]
["使用说明：\n    1．根据《兽药非临床研究质量管理规范》（以下简称兽药GLP）制定本标准。\n    2．本标准共涉及检查条款285项，关键条款（条款后加“*”）75条，一般条款210条。\n    3．在实施兽药GLP监督检查时，须确定相应的检查项目。根据检查项目分别进行评定，在对应项目下填写评定结果。\n    4．评定方式：评定结果分为“Y”“Yˉ”“N”3档。凡某条款得分在75分以上的，判定为符合要求，评定结果标为“Y”；凡某条款得分在50-75分之间的，判定为基本符合要求，评定结果标为“Yˉ”；凡某条款得分在50分以下的，判定为不符合要求，评定结果标为“N”。对于不涉及的条款，标为“/”。\n    5.结果统计：一般条款中，1个“N”折合成3个“Yˉ”，关键条款的“N”不折合为“Yˉ”，结果按下表统计。",{"$nulls":4}," "]
["    6．结果评定"]
["关键条款缺陷","一般条款缺陷","结 论"]
["N＜1 且 Yˉ≤2"," Yˉ≤32","基本符合兽药GLP要求"]
["N≥1 ",null,"不符合兽药GLP要求"]
["N＜1 且 Yˉ＞2"]
[null,"Yˉ＞32"]

{"sheet":"检查项目","index":1,"n_rows":337,"n_cols":13,"rows_kept":337,"merged":[[0,0,0,2],[0,3,0,5],[1,0,1,2],[2,0,3,1],[2,2,3,2],[2,3,2,12],[4,1,4,12],[5,2,5,12],[8,2,8,12],[19,2,19,12],[41,2,41,12],[60,2,60,12],[76,2,76,12],[84,1,84,12],[85,2,85,12],[94,2,94,12],[108,2,108,12],[113,2,113,12],[118,1,118,12],[119,2,119,12],[130,2,130,12],[143,2,143,12],[146,2,146,12],[155,2,155,12],[159,1,159,12],[160,2,160,12],[185,2,185,12],[191,1,191,12],[192,2,192,12],[195,2,195,12],[200,2,200,12],[216,2,216,12],[220,2,220,12],[229,2,229,12],[233,2,233,12],[237,2,237,12],[252,2,252,12],[257,1,257,12],[258,2,258,12],[267,2,267,12],[276,2,276,12],[280,1,280,12],[281,2,281,12],[289,1,289,12],[290,2,290,12],[295,2,295,12],[300,2,300,12],[305,2,305,12],[310,2,310,12],[315,2,315,12],[320,2,320,12],[325,2,325,12],[330,2,330,12],[336,2,336,12]],"flags":["formulas_cached_only"]}
["被检查单位名称：",null,null,"检查时间："]
["试验项目名称："]
["序号",null,"检 查 项 目","评定结果"]
[{"$nulls":3},"H1急性毒性试验","H2亚慢性毒性试验","H3繁殖毒性试验","H4遗传毒性试验","H5慢性毒性试验","H6局部毒性试验","H7安全性药理试验","H8毒代动力学试验","H9放射性或生物危害性药物毒性试验","H10其他毒性试验"]
[null,"A. 组织机构和人员"]
[null,"A1","组织管理体系"]
[1,"A1.1*","组织机构设置合理"]
[2,"A1.2*","人员职责分工明确"]
[null,"A2","人员"]
[3,"A2.1*","经过GLP培训，熟悉GLP的内容"]
[4,"A2.2*","经过专业培训，具备所承担的研究工作需要的知识结构、工作经验和业务能力"]
[5,"A2.3","经过考核，并取得上岗资格"]
[6,"A2.4","严格履行各自职责"]
[7,"A2.5","熟练掌握所承担工作有关的标准操作规程"]
[8,"A2.6*","严格执行与所承担工作有关的标准操作规程"]
[9,"A2.7","对实验中发生的可能影响实验结果的任何情况应及时向项目负责人报告"]
[10,"A2.8","着装符合所从事工作的需要"]
[11,"A2.9","确保受试品、对照品和实验系统不受污染"]
[12,"A2.10","定期体检，遵守个人卫生和健康规定，无影响研究结果可靠性的患病者参加研究工作"]
[null,"A3","机构负责人"]
[13,"A3.1","具备兽医学、药学、生物学等相关专业本科以上学历"]
[14,"A3.2","具有高级专业技术职称"]
[15,"A3.3","具有兽药非临床研究经验"]
[16,"A3.4","本领域工作5年以上"]
[17,"A3.5*","能够全面负责本机构的建设和管理"]
[18,"A3.6","建有工作人员学历的档案资料"]
[19,"A3.7","建有工作人员专业培训和GLP培训的档案资料 "]
[20,"A3.8","建有工作人员专业工作经历的档案资料"]
[21,"A3.9","建有工作人员健康档案资料 "]
[22,"A3.10","负责突发事件应急预案的制定及实施"]
[23,"A3.11*","确保有足够数量的合格人员，并按规定履行其职责"]
[24,"A3.12","任命质量保证部门的负责人，并确保其履行职责"]
[25,"A3.13","制订主计划表，掌握各项研究工作的进展"]
[26,"A3.14","在每项研究工作开始前，指定项目负责人"]
[27,"A3.15","如存在更换项目负责人的情况，有更换的原因和时间的记录"]
[28,"A3.16","组织制定、修订、废止标准操作规程"]
[29,"A3.17","审查批准实验方案"]
[30,"A3.18","审查批准总结报告"]
[31,"A3.19","及时处理质量保证部门的报告，提出处理意见"]
[32,"A3.20","确保受试品、对照品的质量和稳定性符合要求"]
[33,"A3.21","与委托或协作单位签订书面合同"]
[null,"A4","质量保证部门（QAU）"]
[34,"A4.1","具有独立的质量保证部门"]
[35,"A4.2","质量保证部门负责人具备兽医学、药学、生物学等相关专业本科以上学历"]
[36,"A4.3*","具备相应的业务素质、工作能力和工作经验，能够独立履行质量保证职责"]
[37,"A4.4","人员数量和非临床研究机构的规模相适应"]
[38,"A4.5","保存本机构主计划表的副本"]
[39,"A4.6","保存本机构正在进行的实验方案的副本"]
[40,"A4.7","保存本机构未归档的总结报告的副本"]
[41,"A4.8","审核实验方案"]
[42,"A4.9","审核实验记录"]
[43,"A4.10","审核总结报告"]
[44,"A4.11*","对每项研究项目实施检查，并制订检查计划"]
[45,"A4.12*","检查记录完整，包括检查的内容、发现的问题、采取的措施、跟踪复查情况等"]
[46,"A4.13","定期检查动物饲养等实验设施"]
[47,"A4.14","定期检查实验仪器设备"]
[48,"A4.15","定期检查档案管理工作"]
[49,"A4.16","向机构负责人和/或项目负责人书面报告检查发现的问题及建议"]
[50,"A4.17","参与制定并确认标准操作规程"]
[51,"A4.18","保存所有标准操作规程的副本"]
[null,"A5","项目负责人（SD）"]
[52,"A5.1","具备兽医学、药学、生物学等相关专业本科以上学历"]
[53,"A5.2","具有高级职称或10年以上相关工作经验"]
[54,"A5.3","组织或参加过兽药非临床研究"]
[55,"A5.4*","全面负责所承担项目的运行、质量和管理"]
[56,"A5.5","制订并严格执行实验方案"]
[57,"A5.6","分析研究结果，撰写总结报告"]
[58,"A5.7","及时提出修订或补充相应的标准操作规程的建议"]
[59,"A5.8","确保参与工作人员明确职责"]
[60,"A5.9*","保证实验人员掌握并严格执行标准操作规程"]
[61,"A5.10","负责研究具体涉及的技术问题"]
[62,"A5.11","掌握研究工作的进展，检查各种实验记录，确保记录及时、直接、准确和清楚"]
[63,"A5.12","详细记录实验中出现的意外情况和采取的措施"]
[64,"A5.13","妥善保管实验过程中的有关资料和标本"]
[65,"A5.14","实验结束后，将实验方案、原始资料、应保存的标本、各种有关的文件和总结报告及时归档"]
[66,"A5.15","及时处理质量保证部门提出的问题，确保研究工作的各环节符合要求"]
[null,"A6","其他岗位负责人"]
[67,"A6.1","受试品管理负责人符合岗位职能要求"]
[68,"A6.2","动物饲育管理负责人符合岗位职能要求"]
[69,"A6.3","临床检验负责人符合岗位职能要求"]
[70,"A6.4","病理负责人符合岗位职能要求"]
[71,"A6.5","标本保管负责人符合岗位职能要求"]
[72,"A6.6","档案管理负责人符合岗位职能要求"]
[73,"A6.7","实验设施保障负责人符合岗位职能要求"]
[null,"B. 实验设施与管理"]
[null,"B1","实验设施"]
[74,"B1.1*","具有与申报的安全性试验项目相适应的实验设施，实验室须通过计量认证或实验室认可，且证书在有效期内"]
[75,"B1.2","各类实验设施保持清洁卫生"]
[76,"B1.3*","实验设备设施运转正常"]
[77,"B1.4*","实验设施布局合理，防止交叉污染"]
[78,"B1.5","配备相应的环境调控设施"]
[79,"B1.6","实验设施周边环境条件（有害化学品、花粉、噪音、粉尘、污染源、绿化面积、居民区等）符合相关要求"]
[80,"B1.7","具备排污设备设施和处理措施"]
[81,"B1.8","具备双路供电系统（或备用电源）"]
[null,"B2","实验动物饲养管理设施"]
[82,"B2.1*","动物饲养设施设计合理、配置适当，试验动物饲养设施与所使用的试验动物级别相符合，应具有《实验动物使用许可证》。试验场所须自建，不得租用"]
[83,"B2.2*","饲养设施能够根据需要调控温度、湿度、空气洁净度、氨浓度、通风和照明等环境条件"]
[84,"B2.3","具有监测温度、湿度和压差等环境条件的设备设施"]
[85,"B2.4","根据实验动物级别，饲养设施内的不同区域保持合理的温度、湿度、压力梯度等环境条件"]
[86,"B2.5","具备所需实验系统的饲养和管理设施"]
[87,"B2.6","具备所需种属动物的饲养和管理设施"]
[88,"B2.7","用于不同研究的实验动物不应饲养于同一饲养室，必须饲养于同一饲养室内的，应有适当的分隔及标记措施"]
[89,"B2.8","动物设施条件与所使用的实验动物级别相符合"]
[90,"B2.9","具有动物的检疫和患病动物的隔离治疗设施"]
[91,"B2.10","具备收集和处置动物尸体、试验废弃物的设施和处理措施"]
[92,"B2.11","具有清洗消毒设施"]
[93,"B2.12*","具备饲料、垫料、笼具及其他动物用品的存放设施，各类设施的配置合理，防止与实验系统相互污染"]
[94,"B2.13","具备易腐败变质的动物用品的保管措施"]
[null,"B3","受试品和对照品的处置设施"]
[95,"B3.1*","具备接收和贮藏受试品、对照品的设施"]
[96,"B3.2","具备受试品、对照品的配制设施和配制物贮存设施"]
[97,"B3.3","具有对受试品的浓度、稳定性、均匀性等质量参数的分析测定的仪器设备或措施"]
[98,"B3.4","受试品和对照品含有挥发性、放射性和生物危害性等物质时，设置相应的实验、储存、配制和处置设施等应符合国家有关规定"]
[null,"B4","实验资料保管设施"]
[99,"B4.1","具备文字资料的保管设施"]
[100,"B4.2","具备各类标本的保管设施"]
[101,"B4.3","具备电子数据存储保管的设施"]
[102,"B4.4","具备防火、防潮和防盗等安全保管措施"]
[null,"C. 仪器设备和实验材料"]
[null,"C1","仪器设备"]
[103,"C1.1*","配备与研究工作相适应的仪器设备"]
[104,"C1.2","放置地点合理"]
[105,"C1.3","专人负责保管"]
[106,"C1.4","定期进行检查、维护保养"]
[107,"C1.5","定期进行校正或自检"]
[108,"C1.6","需要进行计量检定的仪器，有计量检定证明"]
[109,"C1.7","实验室内备有本实验室仪器设备保养、校正及使用方法的标准操作规程"]
[110,"C1.8","具有仪器的状态标识和编号"]
[111,"C1.9*","仪器设备具有购置、安装、验收、使用、检查、测试、保养、校正及故障修理的详细记录并存档"]
[112,"C1.10","根据仪器性能的要求定期进行操作和性能验证，安装、操作、性能验证（IQ/OQ/PQ）的数据和记录应存档。"]
[null,"C2","受试品和对照品"]
[113,"C2.1","专人保管"]
[114,"C2.2*","有完善的接收、登记、分发和返还记录"]
[115,"C2.3","有批号、稳定性、含量或浓度、纯度及其它理化性质的记录"]
[116,"C2.4","贮存保管条件应符合要求"]
[117,"C2.5*","贮存的容器贴有标签，标示品名、缩写名、代号、批号、有效期和贮存条件"]
[118,"C2.6","分发过程中避免污染或变质的措施"]
[119,"C2.7","分发时应贴有准确的标签"]
[120,"C2.8","按批号记录分发、归还的日期和数量"]
[121,"C2.9","受试品和对照品与介质混合时，应定期测定混合物中受试品和对照品的浓度和稳定性"]
[122,"C2.10","受试品和对照品与介质混合后，混合物标签标识准确并注明有效期"]
[123,"C2.11","每个批次的受试品都应保留足够用于分析的样品量，留样期限应与实验的原始数据和留样样本的保留期限相同。"]
[124,"C2.12*","特殊药品的贮存、保管和使用符合有关规定"]
[null,"C3","实验室的试剂和溶液"]
[125,"C3.1*","实验室的试剂和溶液均贴有标签，标明品名、浓度、贮存条件、配制人、配制日期、启用日期及有效期等，并建立相应的配制及使用记录台账"]
[126,"C3.2","试验中未使用变质或过期的试剂和溶液"]
[null,"C4","动物的饲养和使用"]
[127,"C4.1","动物的饲料和饮水定期检验，确保其符合营养和卫生标准"]
[128,"C4.2","动物的饲料和饮水中污染物质的含量符合国家相关规定"]
[129,"C4.3","动物的垫料污染物质的含量符合规定"]
[130,"C4.4","动物的饲料和垫料应贴有标签，标明来源、购入日期、有效期等"]
[131,"C4.5","动物的饲料、饮水和垫料的定期检验结果作为原始资料保存"]
[132,"C4.6","动物饲养室内使用的清洁剂、消毒剂及杀虫剂应符合要求，不影响实验结果，并详细记录其名称、浓度、使用方法和使用的时间等"]
[133,"C4.7","实验动物的使用应经由动物伦理委员会及技术委员会的论证批准"]
[134,"C4.8*","使用健康无病、无人畜共患疾病病原体的动物"]
[null,"C5","体外实验材料（微生物、细胞、组织、器官等）"]
[135,"C5.1","体外实验使用材料有明确的来源"]
[136,"C5.2","体外实验使用材料的保存和使用条件适当"]
[137,"C5.3","体外实验使用材料的保存和使用记录完整"]
[null,"D. 标准操作规程（SOP）"]
[null,"D1","SOP的制订"]
[138,"D1.1*","制订有与实验工作相适应的SOP"]
[139,"D1.2","SOP的制订、修改、销毁和管理的SOP"]
[140,"D1.3","质量保证的SOP"]
[141,"D1.4","受试品和对照品接收、登记、标识、保存、分发、返还的SOP"]
[142,"D1.5","受试品和对照品处理、配制、领用的SOP"]
[143,"D1.6","受试品和对照品取样分析的SOP"]
[144,"D1.7","动物实验设施管理和环境调控的SOP"]
[145,"D1.8","功能实验室管理和环境调控的SOP"]
[146,"D1.9","实验设施和仪器设备使用、维护、保养、校正和管理的SOP"]
[147,"D1.10","计算机系统操作和管理的SOP"]
[148,"D1.11","实验动物运输与接收的SOP"]
[149,"D1.12","实验动物检疫的SOP"]
[150,"D1.13","实验动物分组与识别的SOP"]
[151,"D1.14","实验动物饲养管理的SOP"]
[152,"D1.15","实验动物的观察记录及实验操作的SOP"]
[153,"D1.16","各种实验样品采集、各种指标的检查和测定等操作技术的SOP"]
[154,"D1.17","濒死或已死亡动物检查处理的SOP"]
[155,"D1.18","动物尸检以及组织病理学检查的SOP"]
[156,"D1.19","实验标本的采集、编号和检验的SOP"]
[157,"D1.20","各种实验数据管理和统计处理的SOP"]
[158,"D1.21","工作人员培训、考核及健康检查制度的SOP"]
[159,"D1.22","动物尸体及其他废弃物处理的SOP"]
[160,"D1.23","资料档案管理的SOP"]
[161,"D1.24","其他工作的SOP"]
[null,"D2","SOP的管理和实施"]
[162,"D2.1","SOP的制定和修订经质量保证部门负责人审查确认"]
[163,"D2.2","SOP的制定和修订经机构负责人书面批准"]
[164,"D2.3","废止的SOP除一份存档之外均应及时销毁"]
[165,"D2.4*","具有SOP的制定、修改、生效日期及分发、销毁记录并归档"]
[166,"D2.5","SOP的存放应方便使用"]
[null,"E. 研究工作的实施"]
[null,"E1","项目名称与代号"]
[167,"E1.1","每项研究均有项目名称或代号，并在有关资料及实验记录中统一使用该名称或代号"]
[168,"E1.2","实验中所采集的各种标本均标明项目名称或代号、动物编号和收集日期"]
[null,"E2","实验方案的制定"]
[169,"E2.1","经项目负责人签名"]
[170,"E2.2","经质量保证部门负责人审查签名"]
[171,"E2.3","经机构负责人批准并签名"]
[172,"E2.4","接受委托的研究实验方案应经委托单位认可"]
[null,"E3","实验方案的内容"]
[173,"E3.1","研究项目的名称或代号及研究目的"]
[174,"E3.2","非临床研究机构和委托单位的名称、地址及联系方式"]
[175,"E3.3","项目负责人和参加实验的工作人员信息"]
[176,"E3.4","受试品和对照品的名称、缩写名、代号、批号、有关理化性质及生物特性等"]
[177,"E3.5","实验系统及选择理由"]
[178,"E3.6","实验动物的种、系、数量、年龄、性别、体重范围、来源和等级"]
[179,"E3.7","实验动物的识别方法"]
[180,"E3.8","实验动物饲养管理的环境条件"]
[181,"E3.9","饲料名称或代号、来源、批号"]
[182,"E3.10","实验用溶媒、乳化剂及其它介质名称和质量要求"]
[183,"E3.11","受试品和对照品的给药途径、方法、剂量、频率和用药期限及选择的理由"]
[184,"E3.12","所用安全性研究指导原则的文件及文献"]
[185,"E3.13","各种指标的检测方法和频率"]
[186,"E3.14","数据统计处理方法及统计软件"]
[187,"E3.15","实验资料的保存地点"]
[null,"E4","研究过程中实验方案的修改"]
[188,"E4.1","经质量保证部门审查"]
[189,"E4.2","经委托单位认可、机构负责人批准"]
[190,"E4.3","有变更的内容、理由及日期的记录并保存"]
[null,"E5","实验操作与记录"]
[191,"E5.1*","参加实验的工作人员，执行实验方案"]
[192,"E5.2*","参加实验的工作人员，执行相应的SOP"]
[193,"E5.3","发现异常时及时记录并向项目负责人报告"]
[194,"E5.4","偏离SOP的操作经项目负责人批准"]
[195,"E5.5","研究过程中偏离SOP和实验方案的操作及原因有记录"]
[196,"E5.6*","记录及时、准确、清晰并不易消除"]
[197,"E5.7","注明记录日期，记录者签名"]
[198,"E5.8","数据修改符合要求"]
[null,"E6","动物出现与受试品无关的异常反应的处理"]
[199,"E6.1","动物出现非受试品引起的疾病或出现干扰研究目的的异常情况时，应立即隔离或处死，及时报告项目负责人并采取措施"]
[200,"E6.2","需要用药物治疗时，治疗措施不得干扰研究结果的可靠性，并经项目负责人批准"]
[201,"E6.3","详细记录治疗的理由、批准手续、检查情况、药物处方、治疗日期和结果等"]
[null,"E7","总结报告"]
[202,"E7.1","经项目负责人签名"]
[203,"E7.2","经质量保证部门负责人审查和签署意见"]
[204,"E7.3","经机构负责人批准"]
[null,"E8","总结报告的内容"]
[205,"E8.1","研究项目的名称或代号及研究目的"]
[206,"E8.2 ","非临床研究机构和委托单位的名称、地址和联系方式"]
[207,"E8.3","研究及实验起止日期"]
[208,"E8.4 ","受试品和对照品的名称、缩写名、代号、批号、稳定性、含量、浓度、纯度、组分及其它特性"]
[209,"E8.5*","实验动物的种、系、数量、年龄、性别、体重范围、来源、合格证号及签发单位、接收日期和饲养条件"]
[210,"E8.6","动物饲料、饮水和垫料的种类、来源、批号和质量情况"]
[211,"E8.7","受试品和对照品的给药途径、剂量、方法、频率和给药期限"]
[212,"E8.8","受试品和对照品的剂量设计依据"]
[213,"E8.9*","影响研究可靠性和造成研究工作偏离实验方案的异常情况"]
[214,"E8.10","各种指标检测方法和频率"]
[215,"E8.11","项目负责人和所有参加工作的人员相关信息和承担的工作内容"]
[216,"E8.12","试验数据；分析数据所用的统计方法及统计软件"]
[217,"E8.13 ","实验结果分析和结论"]
[218,"E8.14","原始资料和标本的保存地点"]
[null,"E9","研究报告的修改"]
[219,"E9.1","总结报告经机构负责人签字后，需要修改或补充时注明修改或补充的内容、理由和日期"]
[220,"E9.2","经项目负责人认可"]
[221,"E9.3","经质量保证部门负责人审查"]
[222,"E9.4","经机构负责人批准"]
[null,"F. 资料档案"]
[null,"F1","试验项目归档材料"]
[223,"F1.1","实验方案（如有修改，同时保存修改前的方案）"]
[224,"F1.2","标本（归档应符合要求）"]
[225,"F1.3*","原始资料（包括电子数据）"]
[226,"F1.4","总结报告的原件"]
[227,"F1.5","与实验有关的各种书面文件"]
[228,"F1.6","质量保证部门的检查记录和报告"]
[229,"F1.7","取消或中止实验的原因的书面说明"]
[230,"F1.8*","完成此次申报兽药GLP试验项目1次以上（近5年）"]
[null,"F2","档案管理符合要求"]
[231,"F2.1*","资料档案室有专人负责，并按SOP的要求进行管理"]
[232,"F2.2","实验方案保存至实验结束后至少7年"]
[233,"F2.3","标本保存至实验结束后至少7年"]
[234,"F2.4","原始资料保存至实验结束后至少7年"]
[235,"F2.5","总结报告及其它资料的保存至实验结束后至少7年"]
[236,"F2.6","申请人应保存资料至兽药被批准上市后5年"]
[237,"F2.7","如果中止开发的，保存至实验结束后2年"]
[238,"F2.8","质量容易变化的标本，如组织器官、电镜标本、血液涂片及繁殖毒性试验标本等的保存期，应以能够进行质量评价为保存时限"]
[null,"F3","其他归档资料完整"]
[239,"F3.1","人员档案（包括体检、人员履历、培训记录等）"]
[240,"F3.2","实验设施、仪器设备档案资料或复印件"]
[241,"F3.3","其他需要存档的资料"]
[null,"G. 其他"]
[null,"G1","实验技术现场考核（抽查）"]
[242,"G1.1","称量、配制、给药、动物解剖等"]
[243,"G1.2","盲样测试（病理诊断、样品检测等）"]
[244,"G2","计算机管理系统"]
[245,"G3","数据采集系统"]
[246,"G4*","未发现弄虚作假行为"]
[247,"G5*","现场检查中无干扰或不配合检查行为"]
[248,"G6","按照兽药GLP的要求完成此次申报试验项目的兽药安全性评价研究"]
[null,"H. 申请的试验项目"]
[null,"H1","急性毒性试验"]
[249,"H1.1*","项目负责人数量和能力能够满足试验项目的需要"]
[250,"H1.2*","专业人员的数量和能力能够满足该试验项目的需要"]
[251,"H1.3*","具有相适应的试验设施"]
[252,"H1.4*","仪器设备能够满足该试验项目的需要"]
[null,"H2","亚慢性毒性试验"]
[253,"H2.1*","项目负责人数量和能力能够满足试验项目的需要"]
[254,"H2.2*","专业人员的数量和能力能够满足该试验项目的需要"]
[255,"H2.3*","具有相适应的试验设施"]
[256,"H2.4*","仪器设备满足试验项目的需要"]
[null,"H3","繁殖毒性试验（含致畸试验）"]
[257,"H3.1*","项目负责人数量和能力能够满足试验项目的需要"]
[258,"H3.2*","专业人员的数量和能力能够满足试验项目的需要"]
[259,"H3.3*","具有相适应的试验设备设施"]
[260,"H3.4*","仪器设备满足试验项目的需要"]
[null,"H4","遗传毒性试验"]
[261,"H4.1*","项目负责人数量和能力能够满足试验项目的需要"]
[262,"H4.2*","专业人员的数量和能力能够满足试验项目的需要"]
[263,"H4.3*","具有相适应的试验设备设施"]
[264,"H4.4*","仪器设备满足试验项目的需要"]
[null,"H5","慢性毒性试验（含致癌试验）"]
[265,"H5.1*","项目负责人数量和能力能够满足试验项目的需要"]
[266,"H5.2*","专业人员的数量和能力能够满足试验项目的需要"]
[267,"H5.3*","具有相适应的试验设备设施"]
[268,"H5.4*","仪器设备满足试验项目的需要"]
[null,"H6","局部毒性试验"]
[269,"H6.1*","项目负责人数量和能力能够满足试验项目的需要"]
[270,"H6.2*","专业人员的数量和能力能够满足试验项目的需要"]
[271,"H6.3*","具有相适应的试验设备设施"]
[272,"H6.4*","仪器设备满足试验的需要"]
[null,"H7","安全性药理试验"]
[273,"H7.1*","项目负责人数量和能力能够满足试验项目的需要"]
[274,"H7.2*","专业人员的数量和能力能够满足试验项目的需要"]
[275,"H7.3*","具有相适应的试验设备设施"]
[276,"H7.4*","仪器设备满足试验项目的需要"]
[null,"H8","毒代动力学试验"]
[277,"H8.1*","项目负责人数量和能力能够满足试验项目的需要"]
[278,"H8.2*","专业人员的数量和能力能够满足试验项目的需要"]
[279,"H8.3*","具有相适应的试验设备设施"]
[280,"H8.4*","仪器设备满足试验项目的需要"]
[null,"H9","放射性或生物危害性药物毒性试验"]
[281,"H9.1*","项目负责人数量和能力能够满足试验项目的需要"]
[282,"H9.2*","从事放射性同位素实验或生物危害性实验技术人员的专业知识、防护知识、教育培训、健康条件和上岗考核等符合国家有关规定，专业人员数量能够满足试验项目的需要"]
[283,"H9.3*","放射性同位素的使用、射线装置的安全和防护设施和其他生物安全防护设施等符合国家有关规定"]
[284,"H9.4*","具有相适应的试验设备设施，实验场所、设施和设备符合相关国家标准、职业卫生标准和安全防护等要求"]
[285,"H9.5*","仪器设备满足试验项目的需要"]
[null,"H10","其他毒性试验"]

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["××试验项目评定结果"]
["章节",null,"条款数量","不涉及项","实际数量","实际数量"]
[{"$nulls":5},"关键条款",null,null,"一般条款"]
[{"$nulls":5},"Y","Yˉ","N","Y","Yˉ","N"]
["A","组织机构和人员",73]
["B","实验设施与管理",29]
["C","仪器设备和实验材料",35]
["D","标准操作规程",29]
["E","研究工作的实施",56]
["F","资料档案",19]
["G","其他",7]
["H","申请的试验项目"]
[null,"总计"]
[null,"综合评定结果","（见使用说明）"]
[null,"检查组成员签名","\n                                            年   月   日"]
[null,"备注：请将一般条款的N折合成Yˉ计算"]