文档介绍：实验室标准 SOP I. 目的: Purpose 综述实验室运作管理各方面的规范。 The purpose ofthis SOP istosummarize Lab Operation management II. 范围: Scope 该SOP 的范围是 XXXXXQC 实验室的管理。 This SOP isapplicable for ShangHai XXXXXQC laboratory operation management. III. 职责: Responsibility QC经理负责建立该 SOP 和维护它的适用性和执行有效性,QC各主管及各组组长负责本 SOP 的具体实施。 QCmanager isresponsible for developing this SOP and maintaining its suitability and effectiveness. All QCsupervisors and group leaders shall implement this SOP. IV. 程序: Procedure SOPs 的架构 Lab Operation SOPs main structure overview ,设施管理:包括但不限于实验室人员资格确认、健康安全卫生管理,设施管理,其主要内容见本 SOP 。Lab personnel, facility management: including but not limited toLab Personnel Qualification, healthy/safety/environment management, facility management. These items content are inthis SOP. SOP 主要包括:Specifications and Test Methods management SOPs include: QC-2 原料/中间体/成品的质量规格的管理 Quality Specification Management ofRaw Material/Intermediate/Finished Product . SOP 主要包括:QC-3 实验室仪器/设备的确认 Laboratory Instruments/Equipment Qualification, SLQC-4 实验室仪器的校准和维护 Laboratory Instruments Calibration and Maintenance 以及每个仪器的操作程序 and all Lab Instruments/Equipment Operation Procedures. SOP :包括样品的接受,保存,监控,使用,处理以及留样:QC-5 实验室样品管理 Laboratory Sample management, including Reserve Samples management. Reference Standard and Reagents management: QC-6 实验室试剂管理 Lab Reagents Managem