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{"sheet":"封面","index":0,"n_rows":18,"n_cols":3,"rows_kept":18,"merged":[[0,0,0,1],[1,0,1,2],[2,0,2,2],[5,0,6,0],[5,1,6,1],[5,2,6,2],[8,2,10,2],[12,0,13,0],[12,1,13,1],[12,2,13,2],[15,2,17,2]],"flags":["formulas_cached_only"]}
["附件3"]
["兽药临床试验质量管理规范监督检查标准（化药、中药）"]
["使用说明：\n1.本标准根据《兽药临床试验质量管理规范》（以下简称兽药GCP）制定。\n2.本标准共涉及条款235条，A表、B表和C表3部分。A表（监督检查综合标准）涉及条款57条，关键条款（条款号前加“*”）20条，一般条款37条；B表（试验项目监督检查标准）涉及条款151条，关键条款66条，一般条款85条；C表（实验项目关键仪器设备监督检查标准）涉及条款27条，全部为关键条款，按具体试验项目选择对应条款使用。\n3.在实施监督检查时，须确定相应的检查范围和内容，按照试验项目进行评定。例如：报告3个试验项目，需使用A表1份，B表3份（分别对3个具体试验项目进行评定）。C表的关键条款按照申请项目对应使用，结果记入试验项目评定表中。         \n4.评定方式：评定结果分为“N”、“Yˉ”和“Y”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“-”。                                                                                                                                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。                   6.A表评定意见为不符合要求的，不再对具体试验项目进行评定。\n"]
["7.结果评定"]
["A表基本表"]
["关键条款的缺陷项目数量","一般条款的缺陷项目数量","评定意见"]
[]
["N＜1 且 Yˉ≤2","Yˉ≤6","基本符合要求,可对申请项目进行评定。"]
["N≥1 ",null,"不符合要求，不再对具体申报项目进行评定。"]
["N＜1 且 Yˉ＞2"]
[null,"Yˉ＞6"]
["B表项目评定标准表"]
["关键条款的缺陷项目数量","一般条款的缺陷项目数量","评定意见"]
[]
["N＜1 且 Yˉ≤2"," Yˉ≤13","该试验项目基本符合兽药GCP要求。"]
["N≥1 ",null,"该试验项目不符合兽药GCP要求。"]
["N＜1 且Yˉ＞2"]
[null,"Yˉ＞13"]

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["A表--兽药GCP监督检查综合标准"]
["序号","章节","条款编号","条款内容"]
[1,"A01 组织机构","A0101*","具有独立的法人资格或有法人代表授权"]
[2,null,"A0102","设置合理的组织机构,各部门职能明确、运行有序"]
[3,null,"A0103","配备与临床试验相适应的管理人员和技术人员"]
[4,null,"A0104","动物管理委员会/伦理委员会"]
[5,"A02 组织机构   负责人","A0201*","相关专业本科以上学历"]
[6,null,"A0202*","相关专业高级职称"]
[7,null,"A0203","经过临床试验技术和GCP培训"]
[8,null,"A0204","组织或参加过兽药临床试验"]
[9,null,"A0205","本领域工作5年以上"]
[10,null,"A0206*","机构负责人变更的，应提供农业部相关机构提供的资格确认有关资料"]
[11,null,"A0207*","熟悉申请人所提供的与临床试验有关的资料与文献"]
[12,"A03 兽药临床试验机构办公室负责人及设施","A0301","设立兽药临床试验机构办公室并配备指定负责人"]
[13,null,"A0302","具有兽医、生物、药学等相关专业基本知识"]
[14,null,"A0303","具有参加或组织过兽药临床试验的专业经历"]
[15,null,"A0304","经过临床试验技术和GCP培训"]
[16,null,"A0305","按照兽药临床试验管理运行模式进行工作"]
[17,null,"A0306","掌握GCP内容和相关法律法规及兽药临床试验管理技术"]
[18,null,"A0307","能协调和解决药物临床试验过程中出现的问题"]
[19,null,"A0308","专用办公室、符合档案管理要求的专用资料档案室、文件柜（带锁）、传真机等办公设备"]
[20,null,"A0309*","样品接收、设盲和揭盲室"]
[21,"A04兽药临床试验管理制度","A0401","兽药临床试验运行管理制度（包括机构办公室工作制度、项目审批制度和临床试验资料归档管理制度等）"]
[22,null,"A0402*","项目的试验用兽药（包括受试兽药和对照兽药）及试验用品的管理制度"]
[23,null,"A0403","设备管理制度"]
[24,null,"A0404*","生物安全防范制度"]
[25,null,"A0405","剧毒品、危险化学品、易制毒化学品安全管理制度"]
[26,null,"A0406*","临床试验动物及废弃物处理制度"]
[27,null,"A0407","动物福利和伦理相关管理制度"]
[28,null,"A0408*","质量控制与质量管理制度"]
[29,null,"A0409","设施与环境控制制度"]
[30,"A04兽药临床试验管理制度","A0410*","试验记录与报告管理制度"]
[31,null,"A0411","试验动物的饲养与管理制度"]
[32,null,"A0412","试验动物房管理制度"]
[33,null,"A0413*","人员培训制度"]
[34,null,"A0414","文件管理制度"]
[35,null,"A0415","合同管理制度"]
[36,null,"A0416","财务等其他相关的管理制度"]
[37,null,"A0417*","防范和处理兽药临床试验中突发事件的应急预案"]
[38,"A05试验设计技术要求","A0501","临床试验方案内容符合有关试验指导原则规定，并经相关负责人批准"]
[39,null,"A0502","兽药临床试验方案设计规范"]
[40,null,"A0503","经试验项目负责人和申请人签字的临床试验方案"]
[41,null,"A0504","经多方签署的多中心临床试验协议"]
[42,null,"A0505","病例记录或试验记录设计规范"]
[43,null,"A0506*","病例报告表全部记录的内容可追溯"]
[44,null,"A0507","兽药临床试验总结报告规范"]
[45,null,"A0508","其他相关试验设计技术要求规范"]
[46,"A06 标准操作规程(SOP) ","A0601","盲底保存SOP "]
[47,null,"A0602*","原始资料记录SOP"]
[48,null,"A0603*","试验数据记录SOP "]
[49,null,"A0604*","病例报告表记录SOP "]
[50,null,"A0605*","兽药临床试验数据管理SOP"]
[51,null,"A0606*","不良事件及严重不良事件处理SOP "]
[52,null,"A0607","严重不良事件报告SOP "]
[53,null,"A0608","实验室检测及质量控制SOP "]
[54,null,"A0609","对各兽药临床试验项目的质量控制SOP "]
[55,null,"A0610","试验资料和文件归档管理SOP "]
[56,null,"A0611","应具有其他相关SOP"]
[57,"A07已完成兽药临床试验情况","A0701*","完成此次申报的兽药临床试验项目1次以上（近5年）"]

{"sheet":"B表-试验项目监督检查标准","index":2,"n_rows":155,"n_cols":4,"rows_kept":155,"merged":[[0,0,0,3],[2,1,7,1],[8,1,10,1],[11,1,18,1],[19,1,22,1],[23,0,23,3],[24,1,30,1],[31,1,32,1],[33,1,38,1],[39,1,43,1],[44,1,51,1],[52,1,60,1],[61,1,69,1],[70,1,74,1],[75,1,83,1],[84,0,84,3],[85,1,90,1],[91,1,92,1],[93,1,116,1],[117,1,119,1],[120,1,137,1],[138,1,139,1],[140,1,148,1],[149,1,152,1],[153,1,154,1]],"flags":["formulas_cached_only"]}
["B表--兽药GCP试验项目监督检查标准"]
["序号","章节","条款编号","条款内容"]
[1,"B01试验项目    负责人","B0101*","兽医、药学等专业本科以上学历"]
[2,null,"B0102*","兽医、药学等专业高级职称或10年以上相关工作经验"]
[3,null,"B0103","经过临床试验技术培训和兽药GCP培训(培训证书)"]
[4,null,"B0104","组织或参加过兽药临床试验"]
[5,null,"B0105","应有权支配参与该项试验的人员和使用该项试验所需的设施设备"]
[6,null,"B0106*","试验项目负责人变更的，应提供农业部相关机构提供的资格确认有关资料"]
[7,"B02兽药临床试验方案","B0201*","兽药临床试验方案由试验项目负责人和申请人签字及公章"]
[8,null,"B0202","兽药临床试验方案内容符合GCP"]
[9,null,"B0203","试验动物主人知情同意书由试验项目负责人与试验动物主人或法定代理人签署"]
[10,"B03 试验用兽药的管理","B0301*","试验用兽药（包括受试兽药和对照兽药）的生产应符合兽药GMP，并有质量合格报告"]
[11,null,"B0302","试验用兽药（包括受试兽药和对照兽药）不得转交他人使用或销售"]
[12,null,"B0303*","试验用兽药（包括受试兽药和对照兽药）的各种记录完整（含设盲、揭盲等记录）"]
[13,null,"B0304*","试验用兽药（包括受试兽药和对照兽药）的剂量和用法与试验方案一致"]
[14,null,"B0305","剩余的试验用兽药（包括受试兽药和对照兽药）退回申请人"]
[15,null,"B0306*","专人管理试验用兽药（包括受试兽药和对照兽药）"]
[16,null,"B0307","剩余临床试验兽药的处理记录"]
[17,null,"B0308","试验用兽药（包括受试兽药和对照兽药）仅用于该临床试验的试验动物"]
[18,"B04数据统计与统计分析","B0401*","数据管理的各种步骤记录在案"]
[19,null,"B0402","具有适当的程序保证数据库的保密性"]
[20,null,"B0403*","试验动物分配与试验设计确定的方案一致"]
[21,null,"B0404","紧急情况破盲述明理由"]
["实验室部分"]
[22,"B05 实验室技术人员","B0501*","3名以上兽医、药学、分析等专业本科及以上学历或中级及以上专业技术职称技术人员"]
[23,null,"B0502*","经过临床试验技术和GCP培训（培训证书）"]
[24,null,"B0503","参加过临床相关试验"]
[25,null,"B0504*","主要测试人员具有完整实施生物样品测试经历和实施样品分析的能力"]
[26,null,"B0505*","熟练操作样本分析仪器"]
[27,null,"B0506","熟练运用专业分析软件处理图谱及相关数据"]
[28,null,"B0507","熟练操作数据分析处理软件"]
[29,"B06 现场测试","B0601","GCP知识测试（随机抽查）"]
[30,null,"B0602","SOP相关内容操作测试（随机抽查）"]
[31,"B07 实验室条件及办公设施","B0701*","实验室须通过计量认证或实验室认可，且证书在有效期内，满足相对独立、功能明确，符合检测和分析流程的要求"]
[32,null,"B0702","具有样本分离、储存以及运输的基本设备"]
[33,null,"B0703","制备样品的专用工作台及通风设备"]
[34,null,"B0704","试验用药品及试验用品专用储藏设施"]
[35,null,"B0705*","实验室计量仪器设备已通过计量检定，并在有效期内"]
[36,null,"B0706","根据需要准备的急救兽药"]
[37,"B08 实验室配备常规仪器设备","B0801","应具有能满足试验项目要求的检验、检测仪器设备"]
[38,null,"B0802","规格齐全的微量加样器"]
[39,null,"B0803","分析仪专用计算机及数据分析处理软件"]
[40,null,"B0804","仪器和实验设备处于可使用的正常状态"]
[41,null,"B0805","仪器和实验设备使用和维修记录完整"]
[42,"B09 临床试验实验室管理制度\n\n","B0901","临床试验实验室人员管理制度"]
[43,null,"B0902","试验用兽药（包括受试兽药和对照兽药）管理制度"]
[44,null,"B0903","专用仪器设备管理制度"]
[45,null,"B0904","对放射标记兽药的管理制度 "]
[46,null,"B0905","放射标记试验样品的处置与保管制度"]
[47,null,"B0906","临床试验实验室质量保证体系"]
[48,null,"B0907","临床试验结果分析质量控制体系"]
[49,null,"B0908","临床试验实验室工作流程"]
[50,"B10 临床试验实验室标准操作规程（SOP）\n\n","B1001","各项检查参数检验SOP "]
[51,null,"B1002","试验数据审核SOP "]
[52,null,"B1003","制定抽查及整改SOP"]
[53,null,"B1004","计量仪器校正SOP "]
[54,null,"B1005","实验室仪器操作SOP "]
[55,null,"B1006","试验数据采集、处理和统计分析SOP "]
[56,null,"B1007","数据和分析结果的打印和保存SOP "]
[57,null,"B1008","测试图谱打印和保存SOP "]
[58,null,"B1009","试验结果和药代参数分析结果打印和保存SOP"]
[59,"B10 临床试验实验室标准操作规程（SOP）\n\n","B1010","试验质量控制SOP（包括实验动物的剔除，结果筛选）"]
[60,null,"B1011","质量控制用样本的制备与分析SOP "]
[61,null,"B1012","电子文档保存SOP "]
[62,null,"B1013","样本测试SOP "]
[63,null,"B1014","样品预处理SOP "]
[64,null,"B1015","分析测试方法学考察SOP "]
[65,null,"B1016","样本特定编码SOP "]
[66,null,"B1017","样本接收、保存和安全处置SOP "]
[67,null,"B1018","临床试验实验室其它相关SOP "]
[68,"B11 质量保证  措施","B1101*","建立临床试验实验室质量保证体系"]
[69,null,"B1102*","建立临床试验结果分析质控体系"]
[70,null,"B1103*","遵循兽药临床试验方案"]
[71,null,"B1104*","执行各种标准操作规程"]
[72,null,"B1105*","接受监查员的监查并记录在案"]
[73,"B12 试验记录","B1201*","试验记录及时、准确、规范、完整、真实"]
[74,null,"B1202*","原始资料保存完整"]
[75,null,"B1203*","病例报告表保存完整"]
[76,null,"B1204*","病例报告表中的数据与原始资料一致"]
[77,null,"B1205*","病例报告表附有实验室原始数据报告记录复印件"]
[78,null,"B1206*","兽药临床试验资料保存至临床试验终止后7年"]
[79,null,"B1207*","试验总结报告与兽药临床试验方案要求一致"]
[80,null,"B1208*","试验总结报告内容符合GCP规定"]
[81,null,"B1209","监查记录保存完整"]
["动物试验部分"]
[82,"B13 动物试验技术人员","B1301*","3人以上承担试验项目相关专业中级或以上职称动物试验技术人员"]
[83,null,"B1302","经过动物实验技术岗前培训"]
[84,null,"B1303*","经过临床试验技术和GCP培训（培训证书）"]
[85,null,"B1304","熟悉应急处理和紧急救治突发临床事件SOP"]
[86,null,"B1305*","参加过临床试验"]
[87,null,"B1306*","能熟练的操作各项设备设施"]
[88,"B14 现场测试","B1401","GCP知识测试（随机抽查）"]
[89,null,"B1402","SOP相关内容测试（随机抽查）"]
[90,"B15 动物试验管理制度及SOP","B1501","动物试验工作人员管理制度"]
[91,null,"B1502","动物试验用兽药（包括受试兽药和对照兽药）管理制度"]
[92,null,"B1503","抢救用兽药管理制度"]
[93,null,"B1504","动物试验仪器设备管理制度"]
[94,null,"B1505","动物试验资料管理制度"]
[95,null,"B1506*","对放射标记兽药试验动物的管理制度"]
[96,null,"B1507*","对放射标记兽药试验的动物尸体和组织的处置制度"]
[97,null,"B1508*","应建立兽医防疫制度"]
[98,null,"B1509","应建立饲料及饲料添加剂管理制度"]
[99,null,"B1510","应建立饲养管理制度"]
[100,null,"B1511","应建立饲养区清洁卫生与消毒制度及SOP，详细记录清洁剂、消毒剂和杀虫剂名称、浓度、使用方法和使用的时间等信息"]
[101,null,"B1512","试验动物的分隔与标识制度及SOP"]
[102,null,"B1513","动物笼具及其他用品的消毒制度及SOP "]
[103,null,"B1514*","饲料和饮水定期检验制度及记录"]
[104,null,"B1515","试验动物的检疫和隔离制度及SOP "]
[105,null,"B1516","制定各种仪器、设备操作SOP "]
[106,null,"B1517*","制定试验动物筛选与入选SOP "]
[107,null,"B1518*","制定不良事件及严重不良事件处理SOP "]
[108,null,"B1519","制定严重不良事件报告SOP "]
[109,null,"B1520","制定试验用兽药（包括受试兽药和对照兽药）接收、保存、分发、回收、返还SOP，并具有可操作性"]
[110,null,"B1521*","制定原始资料归档和保存SOP，并具有可操作性"]
[111,null,"B1522*","制定样本采集、分离、保存、运送和交接SOP "]
[112,null,"B1523","制定样本特定编码SOP "]
[113,null,"B1524*","建立兽药临床试验动物试验质量保证体系"]
[114,"B16 试验设施与动物的管理","B1601*","动物试验场所须具备合法的生产营业执照，具有《动物防疫条件合格证》/《实验动物使用许可证》。"]
[115,null,"B1602*","租用的动物试验场所的，应签订长期合同。动物试验场变更的应提供通过核查的有关资料。"]
[116,null,"B1603*","试验动物饲养设施与所使用的试验动物级别相符合，应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"]
[117,"B16 试验设施与动物的管理","B1604*","需要攻毒试验的，应具有与试验项目相符的生物安全设施，试验应符合国家生物安全有关规定。"]
[118,null,"B1605","承担临床试验项目要求的功能间（检疫隔离室、动物饲养室、动物解剖室、临床检验室、样品采集室、微生物实验室、病理室）"]
[119,null,"B1606*","饲养场周围一定范围内应无其它饲养场、牲畜（活禽）交易市场、屠宰场、生活水源地和居民居住区。"]
[120,null,"B1607*","临床试验动物来源、健康证明和资料应完整保存"]
[121,null,"B1608*","试验动物的种类、品系、性别、年龄、体重、营养状况、健康等级等应有相应记录"]
[122,null,"B1609","试验动物级别及检测报告，可追溯供应商的生产许可证"]
[123,null,"B1610","检疫观察期对观察项目做详细记录并保留存档    "]
[124,null,"B1611*","进入饲养区的人员进出登记记录"]
[125,null,"B1612","饲料、饮水的质量符合国家相关规定"]
[126,null,"B1613","饲料应贴有标签，标明来源、购入日期、有效期等"]
[127,null,"B1614","饲料和饮水定期检验结果作为原始资料保存"]
[128,null,"B1615*","临床试验动物样品采集、处理与贮存条件"]
[129,null,"B1616*","具备动物尸体及试验废弃物收集、处置的设施和无害化处置措施"]
[130,null,"B1617*","对感染性试验的动物尸体和组织具备高压灭菌设施和处理措施"]
[131,null,"B1618*","对放射标记药物试验的动物尸体和组织的处置设施和措施"]
[132,null,"B1619","试验动物及其产品可供人消费的限制性条件及措施"]
[133,null,"B1620","试验用兽药（包括受试兽药和对照兽药）及试验用品专用配置及储藏设施"]
[134,null,"B1621","根据需要准备的急救兽药及存放设施"]
[135,"B17 质量保证实施情况","B1701*","临床试验过程执行各种标准操作规程"]
[136,null,"B1702*","接受监查员的监查并记录在案"]
[137,"B18 试验记录","B1801*","试验记录及时、准确、规范、完整、真实"]
[138,null,"B1802*","原始资料保存完整"]
[139,null,"B1803*","病例报告表保存完整"]
[140,null,"B1804*","病例报告表中的数据与原始资料一致"]
[141,null,"B1805*","病例报告表上附实验室原始数据报告记录复印件"]
[142,null,"B1806*","兽药临床试验资料保存至临床试验终止后7年"]
[143,null,"B1807*","试验总结报告与试验方案要求一致"]
[144,null,"B1808*","试验总结报告内容符合GCP规定"]
[145,null,"B1809","监查记录保存完整"]
[146,"B19 不良事件","B1901","对试验动物安全采取必要的保护措施"]
[147,null,"B1902","保证不良事件发生的试验动物及时得到适当的治疗"]
[148,null,"B1903*","所有不良事件记录在案"]
[149,null,"B1904","严重不良事件按规定报告"]
[150,"B20多中心试验","B2001*","临床试验遵循多中心统一的兽药临床试验方案"]
[151,null,"B2002","临床试验开始及进行中期组织或参加试验项目负责人会议"]

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["C表--兽药GCP试验项目关键仪器设备监督检查标准"]
["序号","试验项目","条款编号","条款内容"]
[1,"C01药效评价试验（Ⅱ期临床试验）","C0101*","超净工作台/生物安全柜、二氧化碳培养箱、生化培养箱、高压灭菌器、恒温培养箱、光学显微镜（配置照相系统）、酶标仪、血球分类计数仪、生化分析仪、尿常规分析仪、                                              抗菌药物或消毒剂对奶牛乳房炎的防治试验:奶牛体细胞计数仪                                         靶动物生殖系统疾病或调控方面的试验:B超仪                                                        靶动物呼吸道疾病的X光诊断：X光机                                                                 采用分子生物学方法鉴定病原菌种类:PCR仪、电泳仪、凝胶成像仪"]
[2,"C02药效评价田间试验（Ⅲ期临床试验）","C0201*","畜禽、宠物同C0101"]
[3,null,"C0202*","水产：同C0101，另加水质分析仪"]
[4,null,"C0203*","蚕药：生物显微镜、恒温培养箱、超净工作台、高压灭菌器、高速冷冻离心机、小型喷雾器等"]
[5,null,"C0204*","蜂药：调温调湿培养箱、光学显微镜、 倒置显微镜、 超净工作台、 二氧化碳培养箱、高压灭菌器、PCR仪、酶标仪、电泳仪、高速冷冻离心机、凝胶成像仪等"]
[6,"C03药代动力学       试验         ","C0301*","畜禽用药： 液相色谱-四级杆多重串联质谱/（超）高效液相色谱仪/气相色谱-质谱联用仪/气相色谱仪、氮吹仪/旋转蒸发仪、涡旋仪、匀浆机、超声波清洗仪、离心机、高速冷冻离心机"]
[7,null,"C0302*","水产用药：水质分析仪，其余同C0301"]
[8,null,"C0303*","宠物用药：同C0301"]
[9,"C04药物代谢    试验","C0301*","畜禽用药： 液相色谱-四级杆多重串联质谱/（超）高效液相色谱仪/气相色谱-质谱联用仪/气相色谱仪、氮吹仪/旋转蒸发仪、涡旋仪、匀浆机、超声波清洗仪、动物代谢笼"]
[10,null,"C0302*","水产用药：水质分析仪，其余同C0301"]
[11,null,"C0303*","宠物用药：同C0301"]
[12,"C05生物等效性   试验（血药法）","C0401*","畜禽用药： 液相色谱-四级杆多重串联质谱/（超）高效液相色谱仪/气相色谱-质谱联用仪/气相色谱仪、氮吹仪/旋转蒸发仪、涡旋仪、匀浆机、超声波清洗仪、离心机、高速冷冻离心机"]
[13,null,"C0402*","水产用药：水质分析仪，其余同C0401"]
[14,null,"C0403*","宠物用药：同C0401"]
[15,"C06残留消除    试验","C0501*","畜禽用药： 液相色谱-四级杆多重串联质谱/高效液相色谱仪/气相色谱-质谱联用仪/气相色谱仪、氮吹仪/旋转蒸发仪、涡旋仪、匀浆机、超声波清洗仪、离心机、高速冷冻离心机"]
[16,null,"C0502*","水产用药：水质分析仪，其余同C0501"]
[17,null,"C0503*","宠物用药：不涉及"]
[18,null,"C0505*","蜂药：同C0501"]
[19,"C07靶动物      安全试验","C0701*","畜禽用药：血球分类计数仪、生化分析仪、尿常规分析仪、切片机、包埋机"]
[20,null,"C0702*","水产用药：水质分析仪、血球分类计数仪、生化分析仪、切片机"]
[21,null,"C0703*","宠物用药：同C0701"]
[22,null,"C0704*","蚕药：生物显微镜、恒温培养箱、超净工作台、高压灭菌器、高速冷冻离心机、小型喷雾器等"]
[23,null,"C0705*","蜂药：调温调湿培养箱、光学显微镜、 倒置显微镜、 超净工作台、 二氧化碳培养箱、高压灭菌器、高速冷冻离心机等"]
[24,"C08消毒剂试验   （实验室消毒试验和现场消毒试验）","C0801*","超净工作台/生物安全柜、二氧化碳培养箱、生化培养箱、高压灭菌锅、恒温培养箱、显微镜、倒置显微镜、细胞培养箱"]
[25,null,"C0802*","水产用药：水质分析仪，其余同C0801"]
[26,null,"C0803*","蚕药：生物显微镜、恒温培养箱、超净工作台、高压灭菌器、高速冷冻离心机、小型喷雾器等"]
[27,null,"C0804*","蜂药：调温调湿培养箱、光学显微镜、 超净工作台、 二氧化碳培养箱、高压灭菌器、电泳仪、高速冷冻离心机等"]

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["兽药GCP监督检查综合标准评定表（化药、中药）  "]
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["试验项目名称："]
["条款序号","评定结果","评定原因","条款序号","评定结果","评定原因"]
[1,null,null,27]
[2,null,null,28]
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["Y的数量："]
["Y-的数量："]
["N的数量："]
["检查组成员签名："]
["填写评定意见",null,"（见使用说明）"]
["备注：","请将一般条款的N折合成Yˉ"]

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["兽药GCP监督检查试验项目评定表（化药、中药）"]
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["试验项目名称",{"$nulls":5},"项目代码"]
["条款序号","评定结果","评定原因",null,"条款序号","评定结果","评定原因"]
[1,{"$nulls":3},29]
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[134,{"$nulls":3},150]
[135,{"$nulls":3},151]
[136,{"$nulls":3},"C表条款"]
["C表条款",{"$nulls":3},"C表条款"]
["C表条款",{"$nulls":3},"C表条款"]
["Y的数量："]
["Y-的数量："]
["N的数量："]
["检查组成员签名："]
["填写评定意见",null,"（见使用说明）"]
["备注：","请将一般条款的N折合成Yˉ"]