替硝唑氯化钠注射液污染水平

替硝唑氯化钠注射液污染水平 佛山双鹤药业有限责任公司 灭菌前替硝唑氯化钠注射液微生物污染水平检查方法 验证 验证类别:检验方法验证 验证对象:灭菌前替硝唑氯化钠注射液 文件编号:DCPC231-QV-Val-VaAM-2012-006 版本号:001 立项部门:质保部QC 佛山双鹤药业有限责任公司 for computer software engineering GB/T50314-2000 of electrical installations code for construction and acceptance of GBJ232- 92 intelligent building weak design construction figure set GJBT-471 2. system description this times engineering weak design including: hours a Kok information facilities system integrated wiring system (containing room network, communications part) wired TV system information guide and the released system hours II Kok public security system fire automatically alarm system (containing public broadcast part) security technology prevention system security monitoring system out entrance control system car library management system hours three Kok building equipment monitoring system hours four Kok information application system queued station ICU visitation system operation the system monitoring and training system call intercom system hours, five hours Kok Kok intelligent integrated system of information system (1) cabling systems (including computer room network, communication component) computer network systems and voice communications systems Center of information on medical floor computer room located in the engine room. Voice communication system using a local telecommunications operator providing voice service, configuration-independent integrated services digital program-controlled switchboards. Operators providing communications ... If any compatibility requirements, by way of increased access to the Communications Board within the chassis to meet 2 方案起草、审批、颁布表 方案名称 灭菌前替硝唑氯化钠注射液微生物污染水平检查 验证方案 方案起草 签名 日期 QC主管 方案审核 签名 日期 验证主管 质保部经理 方案批准 签名 日期 质量负责人 方案的颁布 原件保存 质保部、QC 质保部QC for computer software engineering GB/T50314-2000 of electrical installations code for construction and acceptance of GBJ232- 92 intelligent building weak design construction figure set GJBT-471 2. system description this times engineering weak design including: hours a Kok information facilities system integrated wiring system (containing room network, communications part) wired TV system information guide and the released system hours II Kok public security system fire automatically alarm system (containing public broadcast part) security technology prevention system security monitoring system out entrance control system car library management system hours three Kok building equipment monitoring system hours four Kok information application system queued station ICU visitation system operation the system monitoring and training system call intercom system hours, five hours Kok Kok intelligent integrated system of information system (1) cabling systems (including computer room network, communication component) computer network systems and voice communications systems Center of information on medical floor computer room located in the engine room. Voice communication system using a local telecommunications operator providing voice service, configuration-independent integrated services digital program-controlled switchboards. Operators providing communications ... If any compatibility requirements, by way of increased access to the Communications Board within the chassis to meet 15 目 录 1(验证目的 .............................................................................................................................. 1 2验证小组成员 ......................................................................................................................... 1 3 验证准备 ................................................................................................................................ 1 3.1软件准备 ............................................................................................................................. 1 3.2 相关人员培训 .................................................................................................................... 2 4验证内容 ................................................................................................................................. 2 ............................................................................................................................ 2 4.1 验证周期 4.2 检验方法依据 .................................................................................................................... 2 ......................................................................................................................... 2 4.3验证项目: 4.4 合格 ............................................................................................................................ 2 4.5 试验所需物品: ................................................................................................................ 2 4.6 菌液制备 ............................................................................................................................ 3 4.7 验证方法 ............................................................................................................................ 3 5验证过程中的偏差及处理 ................................................................... 错误～未定义书签。 6 确认结果评定与结论 .......................................................................... 错误～未定义书签。 7再验证周期 ........................................................................................... 错误～未定义书签。 8 编写验证报告 ...................................................................................... 错误～未定义书签。 for computer software engineering GB/T50314-2000 of electrical installations code for construction and acceptance of GBJ232- 92 intelligent building weak design construction figure set GJBT-471 2. system description this times engineering weak design including: hours a Kok information facilities system integrated wiring system (containing room network, communications part) wired TV system information guide and the released system hours II Kok public security system fire automatically alarm system (containing public broadcast part) security technology prevention system security monitoring system out entrance control system car library management system hours three Kok building equipment monitoring system hours four Kok information application system queued station ICU visitation system operation the system monitoring and training system call intercom system hours, five hours Kok Kok intelligent integrated system of information system (1) cabling systems (including computer room network, communication component) computer network systems and voice communications systems Center of information on medical floor computer room located in the engine room. Voice communication system using a local telecommunications operator providing voice service, configuration-independent integrated services digital program-controlled switchboards. Operators providing communications ... If any compatibility requirements, by way of increased access to the Communications Board within the chassis to meet 佛山双鹤药业有限责任公司 灭菌前替硝唑氯化钠注射液微生物污染水平检查验证方案 DCPC231-QV-Val-VaAM-2012-002 版本001 第1页/总11页 1(验证目的 确认所采用的方法(薄膜过滤法)，适合于灭菌前替硝唑氯化钠注射液微生物污染水平检查,即确认供试品在该检验量、该检验条件下无抑菌活性或其抑菌活性以已被充分消除到可以忽略不计。保证检验结果的准确、可靠及检验方法的完整性。 2验证小组成员 分项 部门 职务 职责 负责人 李雄兵 质保部 质保部经理 组长、总协调 林映美 质保部 QC主管 方案起草、报告起草 陈间梅 质保部 验证主管 方案及报告的审核 胡少贞 质保部 QA主管 负责取样、组织协调 李碗君 质保部 QC 检验 陈俏桃 质保部 QC 检验 3 验证准备 3.1软件准备 文件名称 存放地点 保管人 微生物限度检查标准 二楼 麦少妹 菌种接代操作规程 二楼 麦少妹 中华人民共和国药典2010版二部附录XI J微生物限度检查法 二楼 麦少妹 YXQ-LS-18SI自动手提式灭菌器操作规程 二楼 林映美 电热鼓风干燥箱标准操作规程 二楼 林映美 YM75B自动控水型不锈钢多功能立式电热蒸汽消毒器操作规程 二楼 林映美 生化培养房标准操作规程 二楼 林映美 生化培养房标准操作规程 二楼 林映美 检查人: 日期: for computer software engineering GB/T50314-2000 of electrical installations code for construction and acceptance of GBJ232- 92 intelligent building weak design construction figure set GJBT-471 2. system description this times engineering weak design including: hours a Kok information facilities system integrated wiring system (containing room network, communications part) wired TV system information guide and the released system hours II Kok public security system fire automatically alarm system (containing public broadcast part) security technology prevention system security monitoring system out entrance control system car library management system hours three Kok building equipment monitoring system hours four Kok information application system queued station ICU visitation system operation the system monitoring and training system call intercom system hours, five hours Kok Kok intelligent integrated system of information system (1) cabling systems (including computer room network, communication component) computer network systems and voice communications systems Center of information on medical floor computer room located in the engine room. Voice communication system using a local telecommunications operator providing voice service, configuration-independent integrated services digital program-controlled switchboards. Operators providing communications ... If any compatibility requirements, by way of increased access to the Communications Board within the chassis to meet 2 3.2 相关人员培训 验证实施前，需对相关人员进行验证方案以及验证中应该掌握的技能进行培训，培训应遵循《人员培训管理规程。培训情况记录于附件1(培训记录为公司固定记录) 4验证内容 4.1 验证周期 独立操作试验，共进行3批。 4.2 检验方法依据 中国药典2010年版药二部、2010年版《药品生产质量管理》实施指南无菌药品。 4.3验证项目: 4.3.1细菌、霉菌及酵母菌计数方法的验证。 4.4 合格标准 1、细菌、霉菌及酵母菌计数方法的验证: 分别计算每次试验组的菌回收率平均不得低于70% 4.5 试验所需物品: 灭菌前替硝唑氯化钠注射液 4.5.1 仪器设备: (1) YM75B自动控水型不锈钢多功能立式电热蒸汽消毒器 (2) YXQ-LS-18SI自动手提式灭菌器 (3) BSC-?A生物安全柜 (4) 101-2A电热鼓风干燥箱 (5)生化培养房 (30,35?) (6)生化培养房(23,28?) (7)HWS26电热恒温水浴锅 4.5.2 验证用培养基 名称 生产厂家 批号 营养琼脂培养基 北京三药科技开发公司 120223 营养肉汤培养基 北京三药科技开发公司 090922 玫瑰红钠琼脂培养基 北京三药科技开发公司 110630 改良马丁培养基 北京三药科技开发公司 120516 for computer software engineering GB/T50314-2000 of electrical installations code for construction and acceptance of GBJ232- 92 intelligent building weak design construction figure set GJBT-471 2. system description this times engineering weak design including: hours a Kok information facilities system integrated wiring system (containing room network, communications part) wired TV system information guide and the released system hours II Kok public security system fire automatically alarm system (containing public broadcast part) security technology prevention system security monitoring system out entrance control system car library management system hours three Kok building equipment monitoring system hours four Kok information application system queued station ICU visitation system operation the system monitoring and training system call intercom system hours, five hours Kok Kok intelligent integrated system of information system (1) cabling systems (including computer room network, communication component) computer network systems and voice communications systems Center of information on medical floor computer room located in the engine room. Voice communication system using a local telecommunications operator providing voice service, configuration-independent integrated services digital program-controlled switchboards. Operators providing communications ... If any compatibility requirements, by way of increased access to the Communications Board within the chassis to meet 佛山双鹤药业有限责任公司 灭菌前替硝唑氯化钠注射液微生物污染水平检查验证方案 DCPC231-QV-Val-VaAM-2012-002 版本001 第3页/总11页 真菌琼脂培养基 北京三药科技开发公司 09118 检查人: 复核人: 4.5.3 验证用菌株: 大肠埃希菌(Escherichia coli)[CMCC(B) 44 102] 金黄色葡萄球菌(Staphylococcus aureus) [CMCC(B) 26 003] 枯草芽孢杆菌(Bacillus subtilis)[CMCC(B) 63 501] 白色念珠菌(Candida albicans)[CMCC(F) 98 001] 黑曲霉(Aspergillus niger)[CMCC(F) 98 003] 备注:菌种的传代次数不得超过5代 4.6 菌液制备 4.6.1 金黄色葡萄球菌、大肠埃希菌、枯草芽孢杆菌菌、白色念珠菌菌悬液制备 分别接种金黄色葡萄球菌、大肠埃希菌、枯草芽孢杆菌的新鲜培养物至营养肉汤培养基中，30?,35?培养18 小时,24 小时;接种白色念珠菌的新鲜培养物至改良马丁培养基中或改良马丁琼脂培养基上，23,28?培养24,48 小时，上述培养物用0.9%无菌氯化钠溶液50~100cfu?ml的菌悬液备用(菌落形成单位)的菌悬液。 4.6.2 黑曲霉菌悬液制备 接种黑曲霉的新鲜培养物至改良马丁琼脂斜面培养基上，23,28?培养5,7天，加入3,5ml 含0.05,(ml/ ml)聚山梨酯80 的0.9%无菌氯化钠溶液，将孢子洗脱。然后，用适宜的方法吸出孢子悬液至无菌试管内，用含0.05,(ml/ ml)聚山梨酯80 的0.9%无菌氯化钠溶液制成每1ml 含孢子数50~100cfu?ml的孢子悬液。 4.6.3 菌液计数:(每种菌液接种2个平皿) 10-7)、大肠埃希菌(稀释级别为10-7)、枯草取上述金黄色葡萄球菌(稀释级别为 芽孢杆菌(稀释级别为10-5)稀释液各1ml，用45?营养琼脂培养基20ml注入平皿，30?,35?培养3天，计数;计数;白色念珠菌(稀释级别为10-6)稀释液1ml，及黑曲霉孢子悬浮液(稀释级别为10-5)稀释液1ml用真菌琼脂培养基20ml注入平皿，23?,28?培养5天，逐日观察并记录。 4.7 验证方法: 细菌、霉菌及酵母菌计数方法的验证至少应进行3次独立的平行试验，并分别计算各试验菌每次试验的回收率。 for computer software engineering GB/T50314-2000 of electrical installations code for construction and acceptance of GBJ232- 92 intelligent building weak design construction figure set GJBT-471 2. system description this times engineering weak design including: hours a Kok information facilities system integrated wiring system (containing room network, communications part) wired TV system information guide and the released system hours II Kok public security system fire automatically alarm system (containing public broadcast part) security technology prevention system security monitoring system out entrance control system car library management system hours three Kok building equipment monitoring system hours four Kok information application system queued station ICU visitation system operation the system monitoring and training system call intercom system hours, five hours Kok Kok intelligent integrated system of information system (1) cabling systems (including computer room network, communication component) computer network systems and voice communications systems Center of information on medical floor computer room located in the engine room. Voice communication system using a local telecommunications operator providing voice service, configuration-independent integrated services digital program-controlled switchboards. Operators providing communications ... If any compatibility requirements, by way of increased access to the Communications Board within the chassis to meet 4 4.7.1 试验组制备 4.7.1 试验组制备 用少量冲洗液(PH7.0氯化钠-蛋白胨溶液)润湿滤膜后将30袋供试品以 160转/分钟的速度，通过滤膜过滤完后，用冲洗液(PH7.0氯化钠-蛋白胨溶液)冲洗共8次，每次冲洗50ml /滤筒，共400ml，其中第7次冲洗时在0.1%蛋白胨水溶液中加入含5ml(0.1mol/L MnSO)溶液作为中和剂，冲洗后分别取上述5种试验菌悬液1ml(50,100cfu)试验4 菌，分别过滤，取出滤膜，菌面朝上贴于琼脂培养基平板上培养。每株试验菌平行制备2个平皿，按平皿菌落计数法测定其菌数, 每片滤膜上的菌落数应不超过100个。 4.7.2 菌液组 取50,100cfu试验菌，分别注入平皿中，立即倾注琼脂培养基，每株试验菌平行制备2个平皿，按平皿菌落计数法测定其菌数。 4.7.3 供试品对照组 用少量冲洗液(PH7.0氯化钠-蛋白胨溶液)润湿滤膜后将30袋供试品以 160转/分钟的速度，通过滤膜过滤完后，用冲洗液(PH7.0氯化钠-蛋白胨溶液)冲洗共4次，每次冲洗50ml /滤筒，共冲洗200ml后，取出滤膜，菌面朝上贴于琼脂培养基平板上培养。细菌、霉菌及酵母菌各制备1个平皿，测定供试品本底菌数。 4.7.4稀释组 用冲洗液(PH7.0氯化钠-蛋白胨溶液)冲洗共4次，每次冲洗50ml /滤筒，共200ml，，在最后一次冲洗时分别取上述5种试验菌悬液1ml(50,100cfu)试验菌，分别过滤，取出滤膜，菌面朝上贴于琼脂培养基平板上培养。每株试验菌平行制备2个平皿，按平皿菌落计数法测定其菌数, 每片滤膜上的菌落数应不超过100个。 4.7.5稀释液对照组 以 160转/分钟的速度，用冲洗液(PH7.0氯化钠-蛋白胨溶液)冲洗共4次，每次冲洗50ml /滤筒，共冲洗200ml后，取出滤膜，菌面朝上贴于琼脂培养基平板上培养。细菌、霉菌及酵母菌各制备1个平皿，测定供试品本底菌数。 4.7.6 阴性对照 直接取过滤膜贴于琼脂培养基平板上培养。 4.7.7 菌数报告规则 以100ml供试品的菌落数报告菌数;若滤膜上无菌落生长，以<1报告菌数。 4.7.8 计算公式 for computer software engineering GB/T50314-2000 of electrical installations code for construction and acceptance of GBJ232- 92 intelligent building weak design construction figure set GJBT-471 2. system description this times engineering weak design including: hours a Kok information facilities system integrated wiring system (containing room network, communications part) wired TV system information guide and the released system hours II Kok public security system fire automatically alarm system (containing public broadcast part) security technology prevention system security monitoring system out entrance control system car library management system hours three Kok building equipment monitoring system hours four Kok information application system queued station ICU visitation system operation the system monitoring and training system call intercom system hours, five hours Kok Kok intelligent integrated system of information system (1) cabling systems (including computer room network, communication component) computer network systems and voice communications systems Center of information on medical floor computer room located in the engine room. Voice communication system using a local telecommunications operator providing voice service, configuration-independent integrated services digital program-controlled switchboards. Operators providing communications ... If any compatibility requirements, by way of increased access to the Communications Board within the chassis to meet 佛山双鹤药业有限责任公司 灭菌前替硝唑氯化钠注射液微生物污染水平检查验证方案 DCPC231-QV-Val-VaAM-2012-002 版本001 第5页/总11页 试验组平均菌落数—供试品对照组平均菌落数试 验组的菌回收率 % , ×100% 菌液组的平均菌落数 稀释组平均菌落数—供试品对照组平均菌落数稀释组的菌回收率 % , ×100% 菌液组的平均菌落数 4.7.9 验证结果及 5验证过程中的偏差及处理 若在验证实施过程中存在偏差，应分析偏差产生的原因并提出处理意见和采取的措施。偏差描述及处理方式，见《偏差管理规程》及《实验室偏差及OOS调查管理规程》。 6确认结果评定与结论 项目验证小组负责收集各项验证、试验结果记录，并对结果数据进行评价后，报验证领导小组批准。 7再验证周期 替硝唑氯化钠注射液的处方发生变动或检验方法改变时，需要对本方案进行调整后作方法学再验证。 国家相关微生物限度检查标准修改后需要对本方法重新进行再验证 8编写验证报告 各阶段确认完成后，验证项目小组将结果汇总，以技术报告的形式汇总验证结果。根据验证结果如需要工艺规程，须修订后和验证结果一并报验证领导小组审批后，着手起草验证报告: 在做验证报告时应当按照验证方案的内容认真核对和审查: 检查主要的验证试验是否按计划完成; 检查验证方案在实施过程中有无修改;修改的理由是否明确并有批准手续; 重要试验结果的记录是否完整; 验证结果是否符合设定的标准;对偏差的结果有否做过调整，是否有适当的解释并 for computer software engineering GB/T50314-2000 of electrical installations code for construction and acceptance of GBJ232- 92 intelligent building weak design construction figure set GJBT-471 2. system description this times engineering weak design including: hours a Kok information facilities system integrated wiring system (containing room network, communications part) wired TV system information guide and the released system hours II Kok public security system fire automatically alarm system (containing public broadcast part) security technology prevention system security monitoring system out entrance control system car library management system hours three Kok building equipment monitoring system hours four Kok information application system queued station ICU visitation system operation the system monitoring and training system call intercom system hours, five hours Kok Kok intelligent integrated system of information system (1) cabling systems (including computer room network, communication component) computer network systems and voice communications systems Center of information on medical floor computer room located in the engine room. Voice communication system using a local telecommunications operator providing voice service, configuration-independent integrated services digital program-controlled switchboards. Operators providing communications ... If any compatibility requirements, by way of increased access to the Communications Board within the chassis to meet 6 获批准。 附件1 : 相关人员培训记录 for computer software engineering GB/T50314-2000 of electrical installations code for construction and acceptance of GBJ232- 92 intelligent building weak design construction figure set GJBT-471 2. system description this times engineering weak design including: hours a Kok information facilities system integrated wiring system (containing room network, communications part) wired TV system information guide and the released system hours II Kok public security system fire automatically alarm system (containing public broadcast part) security technology prevention system security monitoring system out entrance control system car library management system hours three Kok building equipment monitoring system hours four Kok information application system queued station ICU visitation system operation the system monitoring and training system call intercom system hours, five hours Kok Kok intelligent integrated system of information system (1) cabling systems (including computer room network, communication component) computer network systems and voice communications systems Center of information on medical floor computer room located in the engine room. Voice communication system using a local telecommunications operator providing voice service, configuration-independent integrated services digital program-controlled switchboards. Operators providing communications ... If any compatibility requirements, by way of increased access to the Communications Board within the chassis to meet 佛山双鹤药业有限责任公司 灭菌前替硝唑氯化钠注射液微生物污染水平检查验证方案 DCPC231-QV-Val-VaAM-2012-002 版本001 第7页/总11页 粘贴处 附件2 微生物污染水平检验结果汇总表 for computer software engineering GB/T50314-2000 of electrical installations code for construction and acceptance of GBJ232- 92 intelligent building weak design construction figure set GJBT-471 2. system description this times engineering weak design including: hours a Kok information facilities system integrated wiring system (containing room network, communications part) wired TV system information guide and the released system hours II Kok public security system fire automatically alarm system (containing public broadcast part) security technology prevention system security monitoring system out entrance control system car library management system hours three Kok building equipment monitoring system hours four Kok information application system queued station ICU visitation system operation the system monitoring and training system call intercom system hours, five hours Kok Kok intelligent integrated system of information system (1) cabling systems (including computer room network, communication component) computer network systems and voice communications systems Center of information on medical floor computer room located in the engine room. Voice communication system using a local telecommunications operator providing voice service, configuration-independent integrated services digital program-controlled switchboards. Operators providing communications ... If any compatibility requirements, by way of increased access to the Communications Board within the chassis to meet 8 检品名称 替硝唑氯化钠注射液 批号: 生产单位 佛山双鹤药业有限责任公司生产 检验日期 年 月 日 检验依据 《中国药典》2010年版二部微生物限度检查法 完成日期 年 月 日 结果 验证加菌数(cfu) 培养基 菌种名称 验证周期 试验组 菌液组 稀释组 回收率% CFU?100mlCFU?100mlCFU?100ml 试稀平平平平平平平平平 验释皿 皿 均 皿 皿 均 皿 皿 均 组 组 金黄色葡萄球菌第一次 第二次 第三次 第一次 第二次 大肠埃希菌 营养琼脂 第三次 培养基 第一次 第二次 枯草芽孢杆菌 第三次 第一次 供试品对照组 第二次 CFU?100ml 第三次 第一次 结果 稀释组 第二次 CFU?100ml 第三次 阴性对照 第一次 白色念珠菌 第二次 第三次 玫瑰红钠 第一次 琼脂培养黑曲霉 第二次 基 第三次 第一次 供试品对照组 结果 第二次 CFU?100ml 第三次 阴性对照 for computer software engineering GB/T50314-2000 of electrical installations code for construction and acceptance of GBJ232- 92 intelligent building weak design construction figure set GJBT-471 2. system description this times engineering weak design including: hours a Kok information facilities system integrated wiring system (containing room network, communications part) wired TV system information guide and the released system hours II Kok public security system fire automatically alarm system (containing public broadcast part) security technology prevention system security monitoring system out entrance control system car library management system hours three Kok building equipment monitoring system hours four Kok information application system queued station ICU visitation system operation the system monitoring and training system call intercom system hours, five hours Kok Kok intelligent integrated system of information system (1) cabling systems (including computer room network, communication component) computer network systems and voice communications systems Center of information on medical floor computer room located in the engine room. Voice communication system using a local telecommunications operator providing voice service, configuration-independent integrated services digital program-controlled switchboards. Operators providing communications ... If any compatibility requirements, by way of increased access to the Communications Board within the chassis to meet 佛山双鹤药业有限责任公司 灭菌前替硝唑氯化钠注射液微生物污染水平检查验证方案 DCPC231-QV-Val-VaAM-2012-002 版本001 第9页/总11页 结果评价: 偏差说明 评价人: 附件3 微生物污染水平检查验证记录 检品名称 替硝唑氯化钠注射液 批号: 生产单位 佛山双鹤药业有限责任公司生产 检验日期 年 月 日 《中国药典》2010年版二部微生物限度检查检验依据 完成日期 年 月 日 法 操作步骤: 结果 验证加菌数(cfu) 菌液组 稀释组 试验组 菌种名菌种 稀释 回收率% 培养基 平皿号 CFU?CFU?CFU?称 代数 级别 100ml100ml100ml 试验组 稀释组 1 金黄色 2 葡萄球 菌 营养琼脂平均值 培养基 1 批号: 大肠埃 2 培养温希菌 平均值 度: 1 枯草芽 2 孢杆菌 平均值 供试品对照组 结果 CFU?100ml for computer software engineering GB/T50314-2000 of electrical installations code for construction and acceptance of GBJ232- 92 intelligent building weak design construction figure set GJBT-471 2. system description this times engineering weak design including: hours a Kok information facilities system integrated wiring system (containing room network, communications part) wired TV system information guide and the released system hours II Kok public security system fire automatically alarm system (containing public broadcast part) security technology prevention system security monitoring system out entrance control system car library management system hours three Kok building equipment monitoring system hours four Kok information application system queued station ICU visitation system operation the system monitoring and training system call intercom system hours, five hours Kok Kok intelligent integrated system of information system (1) cabling systems (including computer room network, communication component) computer network systems and voice communications systems Center of information on medical floor computer room located in the engine room. Voice communication system using a local telecommunications operator providing voice service, configuration-independent integrated services digital program-controlled switchboards. Operators providing communications ... If any compatibility requirements, by way of increased access to the Communications Board within the chassis to meet 10 稀释液对照组 CFU?100ml 阴性对照 白色念1 珠 菌 2 1 玫瑰红钠2 黑曲霉 琼脂培养 基 平均值 批号: 培养温度 供试品对照组CFU?100ml 结 果 稀释液对照组CFU?100ml 阴性对照 检验人: 复核人: 日期: 附件4 验证结果审核表 评审内容 评审结论 验证项目是否有遗漏? 是 ? 否 ? 验证实施过程中对验证报告有无修改, 有 ? 无 ? 验证报告修改原因、依据是否经过批准, 是 ? 否 ? 验证记录是否完整, 是 ? 否 ? 验证结果是否符合标准要求, 是 ? 否 ? 如有异常情况,处理是否合理, 是 ? 否 ? 是否需要进一步补充验证, 是 ? 否 ? 验证结果是否均合格, 是 ? 否 ? for computer software engineering GB/T50314-2000 of electrical installations code for construction and acceptance of GBJ232- 92 intelligent building weak design construction figure set GJBT-471 2. system description this times engineering weak design including: hours a Kok information facilities system integrated wiring system (containing room network, communications part) wired TV system information guide and the released system hours II Kok public security system fire automatically alarm system (containing public broadcast part) security technology prevention system security monitoring system out entrance control system car library management system hours three Kok building equipment monitoring system hours four Kok information application system queued station ICU visitation system operation the system monitoring and training system call intercom system hours, five hours Kok Kok intelligent integrated system of information system (1) cabling systems (including computer room network, communication component) computer network systems and voice communications systems Center of information on medical floor computer room located in the engine room. Voice communication system using a local telecommunications operator providing voice service, configuration-independent integrated services digital program-controlled switchboards. Operators providing communications ... If any compatibility requirements, by way of increased access to the Communications Board within the chassis to meet 佛山双鹤药业有限责任公司 灭菌前替硝唑氯化钠注射液微生物污染水平检查验证方案 DCPC231-QV-Val-VaAM-2012-002 版本001 第11页/总11页 确认结论 验证项目组长: 日期: QC负责人: 日期: 审核 质保部负责人: 日期: QA: 日期: 批准 验证领导小组组长: 日期: for computer software engineering GB/T50314-2000 of electrical installations code for construction and acceptance of GBJ232- 92 intelligent building weak design construction figure set GJBT-471 2. system description this times engineering weak design including: hours a Kok information facilities system integrated wiring system (containing room network, communications part) wired TV system information guide and the released system hours II Kok public security system fire automatically alarm system (containing public broadcast part) security technology prevention system security monitoring system out entrance control system car library management system hours three Kok building equipment monitoring system hours four Kok information application system queued station ICU visitation system operation the system monitoring and training system call intercom system hours, five hours Kok Kok intelligent integrated system of information system (1) cabling systems (including computer room network, communication component) computer network systems and voice communications systems Center of information on medical floor computer room located in the engine room. Voice communication system using a local telecommunications operator providing voice service, configuration-independent integrated services digital program-controlled switchboards. Operators providing communications ... If any compatibility requirements, by way of increased access to the Communications Board within the chassis to meet