laboratory+control实验室控制.pdfVIP

LABORATORY CONTROL 实验室控制 CONTENTS内容 1.0 Facilities 场地 2.0 Equipment 设备 2.1 Calibration 校验 2.2 Maintenance 维护 3.0 Validation 验证 3.1 Equipment 设备 3.2 Analytical methods 分析方法 3.3 Computerised systems 计算机系统 4.0 Laboratory Records 实验室记录 4.1 Raw data 原始数据 4.2 Retention of data 数据保存 5.0 Reagents and Reference standards 试剂和标准品 5.1 Reagents 试剂 5.2 Primary reference standards 一级标准品 5.3 Secondary Reference standards 二级标准品 6.0 Specifications, sampling plans and test procedures 规格、取样计划和测试程序 6.1 Specifications 规格 6.2 Sampling 取样 6.3 Test procedures 测试程序 7.0 Stability Testing 稳定性试验 7.1 Programme 方案 8.0 Change Control 变更 Facilities场地 • There should have adequate laboratory facilities 实验室场地应足够宽敞 • A logical segregation in lab实验室应合理分区: • instrumentation lab仪器室 • wet lab 清洗间 • Microbiology lab微生物实验室 • Microbiology lab should have following areas; 微生物实验室应包括以下区域 • Microbial limit test area 微生物限度测试区 • Positive test area阳性菌测试区 • Sterility test area无菌测试区 • Incubation area培养区 • Media destruction area培养基灭活区 • Media preparation and washing area培养基制备和清洗区 • Microbiology lab should be designed with the same concept as it is done for production area. Sterility test lab should be designed as Class B with Class A as working zone. Washing and media preparation area should be minimum class D (class C is recommended) 微生物实验室设计理念应该与生产区一样。无菌测试实验室应设计成B级区，工作区为A 级。清洗和培养基配制区域至少应为D级（推荐C级） Facilities场地 • Facilities should be available for 场地应可以进行 • sample receiving and distribution样品接收和分发