文档介绍：实验室管理SOP
I. 目的:Purpose
综述实验室运作管理各方面的规范。The purpose of this SOP is to summarize Lab Operation management.
II. 范围:Scope
该SOP的范围是XXXXXQC实验室的管理。This SOP is applicable 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。QC manager is responsible for developing this SOP and maintaining its suitability and effectiveness. All QC supervisors and group leaders shall implement this SOP.
IV. 程序:Procedure
A. 实验室运作SOPs的架构 Lab Operation SOPs main structure overview
1. 实验室人员, 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 to Lab Personnel Qualification, healthy/safety/environment management, facility management. These items content are in this SOP.
2. 质量规格和测试方法管理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 of Raw Material/Intermediate/Finished Product .
: 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.
3. 实验室样品的管理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.
Standard and Reagents management: QC-6 实验室试剂管理 Lab Reagents