2022年GMP知识竞赛题库IV供学习 .pdf

20XX 年 GMP 知识竞赛题库（无菌药品附录）第一章范围一、填空题：1.无菌药品附录适用于无菌制剂生产（）以及无菌原料药的（）和（）生产过程。答案：全过程、灭菌、无菌二、名词解释：1.无菌药品答案：无菌药品是指法定药品标准中列有无菌检查项目的制剂和原料药，包括无菌制剂和无菌原料药。第二章原则一、填空题：1.无菌药品按生产工艺可分为两类：采用最终灭菌工艺的为（）；部分或全部工序采用无菌生产工艺的为（）。答案：最终灭菌产品、非最终灭菌产品2.无菌药品生产的人员、设备和物料应通过气锁间进入洁净区，采用机械连续传输物料的，应当用（）保护并监测（）。答案：正压气流、压差第三章洁净度级别及监测一、填空题：1.洁净区的设计必须符合相应的洁净度要求，包括达到“（）”和“（）”的标准。答案：静态、动态2.无菌药品生产所需的洁净区可分为（）、（）、（）、（）四个级别。答案：A、B、C、D 文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S53.在确认级别时，应当使用采样管较短的便携式尘埃粒子计数器，避免5.0 m 悬浮粒子在远程采样系统的长采样管中沉降。在单向流系统中，应当采用（）的取样头。答案：等动力学4.动态测试可在常规操作、培养基模拟灌装过程中进行，证明达到动态的洁净度级别，但培养基模拟灌装试验要求在“（）”下进行动态测试。答案：最差状况二、名词解释1.B 级：指无菌配制和灌装等高风险操作A级洁净区所处的背景区域。三、问答题：（一）、应当按什么要求对洁净区的悬浮粒子进行动态监测：1.根据洁净度级别和空气净化系统确认的结果及风险评估，确定取样点的位置并进行日常动态监控。2.在关键操作的全过程中，包括设备组装操作，应当对A级洁净区进行悬浮粒子监测。生产过程中的污染（如活生物、放射危害）可能损坏尘埃粒子计数器时，应当在设备调试操作和模拟操作期间进行测试。A 级洁净区监测的频率及取样量，应能及时发现所有人为干预、偶发事件及任何系统的损坏。灌装或分装时，由于产品本身产生粒子或液滴，允许灌装点 5.0 m的悬浮粒子出现不符合标准的情况。3.在 B级洁净区可采用与A级洁净区相似的监测系统。可根据B级洁净区对相邻A级洁净区的影响程度，调整采样频率和采样量。4.悬浮粒子的监测系统应当考虑采样管的长度和弯管的半径对测试结果的影响。5.日常监测的采样量可与洁净度级别和空气净化系统确认时的空气采样量不同。6.在 A级洁净区和 B级洁净区，连续或有规律地出现少量5.0 m 的悬浮粒子时，应当进行调查。7.生产操作全部结束、操作人员撤出生产现场并经1520 分钟（指导值）自净后，洁净区的悬浮粒子应当达到表中的“静态”标准。文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S58.应当按照质量风险管理的原则对C级洁净区和 D级洁净区（必要时）进行动态监测。监控要求以及警戒限度和纠偏限度可根据操作的性质确定，但自净时间应当达到规定要求。9.应当根据产品及操作的性质制定温度、相对湿度等参数，这些参数不应对规定的洁净度造成不良影响。（二）、以上各级别空气悬浮粒子的标准规定如下表：洁净度级别悬浮粒子最大允许数/立方米静态动态(3)0.5 m 5.0 m(2)0.5 m 5.0 m A级(1)3520 20 3520 20 B级3520 29 352000 2900 C级352000 2900 3520000 29000 D级3520000 29000 不作规定不作规定洁净区微生物监测的动态标准(1)如下：洁净度级别浮游菌cfu/m3沉降菌（90mm）cfu/4小时(2)表面微生物接触（55mm）cfu/碟5 指手套cfu/手套A级1 1 1 1 B级10 5 5 5 C级100 50 25 D级200 100 50（三）、简述无菌药品生产操作环境的选择？无菌药品的生产操作环境可参照表格中的示例进行选择。洁净度级别最终灭菌产品生产操作示例C 级背景下的局部 A级高污染风险(1)的产品灌装（或灌封）C级1.产品灌装（或灌封）；2.高污染风险(2)产品的配制和过滤；文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S53.眼用制剂、无菌软膏剂、无菌混悬剂等的配制、灌装（或灌封）；4.直接接触药品的包装材料和器具最终清洗后的处理。D级1.轧盖；2.灌装前物料的准备；3.产品配制（指浓配或采用密闭系统的配制）和过滤直接接触药品的包装材料和器具的最终清洗。注：（1）此处的高污染风险是指产品容易长菌、灌装速度慢、灌装用容器为广口瓶、容器须暴露数秒后方可密封等状况；（2）此处的高污染风险是指产品容易长菌、配制后需等待较长时间方可灭菌或不在密闭系统中配制等状况。洁 净 度 级别非最终灭菌产品的无菌生产操作示例B级背景下的 A级1.处于未完全密封(1)状态下产品的操作和转运，如产品灌装（或灌封）、分装、压塞、轧盖(2)等；2.灌装前无法除菌过滤的药液或产品的配制；3.直接接触药品的包装材料、器具灭菌后的装配以及处于未完全密封状态下的转运和存放；4.无菌原料药的粉碎、过筛、混合、分装。B级1.处于未完全密封(1)状态下的产品置于完全密封容器内的转运；2 直接接触药品的包装材料、器具灭菌后处于密闭容器内的转运和存放。C级1.灌装前可除菌过滤的药液或产品的配制；2.产品的过滤。D级直接接触药品的包装材料、器具的最终清洗、装配或包装、灭菌。注：（1）轧盖前产品视为处于未完全密封状态。（2）根据已压塞产品的密封性、轧盖设备的设计、铝盖的特性等因素，轧盖操作可选择在 C级或 D级背景下的 A级送风环境中进行。A级送风环境应当至少符合A级区的静态要求。第四章隔离操作技术一、填空题：1.高污染风险的操作宜在隔离操作器中完成。隔离操作器及其所处环境的设计，应当能文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5够保证相应区域空气的质量达到设定标准。传输装置可设计成（）或（），也可是同灭菌设备相连的（）。答案：单门、双门、全密封系统2.隔离操作器所处环境取决于其设计及应用，无菌生产的隔离操作器所处的环境至少应为（）。答案：D级洁净区3.隔离操作器和隔离用袖管或手套系统应当进行常规监测，包括经常进行必要的（）。答案：检漏试验第五章吹灌封技术一、以下填空题以选择题形式出：1.用于生产最终灭菌产品的吹灌封设备至少应当安装在（）洁净区环境中。答案：D级第六章人员一、填空题：1.凡在洁净区工作的人员（包括清洁工和设备维修工）应当定期培训，使无菌药品的操作符合要求。培训的内容应当包括卫生和微生物方面的基础知识。未受培训的外部人员（如外部施工人员或维修人员）在生产期间需进入洁净区时，应当对他们进行特别详细的（）和（）。文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5答案：指导、监督2.个人外衣不得带入通向 B级或C 级洁净区的更衣室。每位员工每次进入A/B级洁净区，应当更换无菌工作服；或每班至少更换（），但应当用监测结果证明这种方法的可行性。操作期间应当经常消毒手套，并在必要时更换（）和（）。答案：一次、口罩、手套二、问答题：1.请简述 A/B级洁净区着装要求？答案：A/B 级洁净区：应当用头罩将所有头发以及胡须等相关部位全部遮盖，头罩应当塞进衣领内，应当戴口罩以防散发飞沫，必要时戴防护目镜。应当戴经灭菌且无颗粒物（如滑石粉）散发的橡胶或塑料手套，穿经灭菌或消毒的脚套，裤腿应当塞进脚套内，袖口应当塞进手套内。工作服应为灭菌的连体工作服，不脱落纤维或微粒，并能滞留身体散发的微粒。第七章厂房一、填空题：1.洁净厂房的设计，应当尽可能避免管理或监控人员不必要的进入。（）洁净区的设计应当能够使管理或监控人员从外部观察到内部的操作。答案：B级2.无菌生产的 A/B 级洁净区内禁止设置（）和（）。答案：水池、地漏3.应当按照气锁方式设计更衣室，使更衣的不同阶段分开，尽可能避免工作服被微生物和微粒污染。更衣室应当有足够的换气次数。更衣室后段的（）应当与其相应洁净区的级别相同。必要时，可将进入和离开洁净区的更衣间分开设置。一般情况下，洗手设施只能安装在更衣的（）。答案：静态级别、第一阶段文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L7A9 HR6C9L6W5P5 ZI2Z3T4Z10S5文档编码:CX2N6Y2L