第二章 制药企业实验室FDA检查列表_check_list_.pdfVIP

现代中药制药论坛资料提供 MANAGERIAL SYSTEM 管理系统 Administrative/Role Responsibilities 管理的作用和职责 YES NO Current organization charts available and accurate? 当前可用的、正确的组织结构图 Policy/procedure that defines the responsibility and authority of QC unit. 规定 QC 部门的权力和职责的方针或程序 Have the responsibilities of each functional group and supervisor been clearly Defined, including testing and operational requirements, SOPs, and all other Critical functions? 每一个分工小组和管理者的职责应有明确的规定，包括测试和操作要求、SOPS 以及其他的关键要 求。 Is an organizational structure in place and properly staffed to assure all required Testing/monitoring support activities are performed? 是否有适当的组织结构，使员工保证所有要求检验、监测支持活动必须被执行。 Is the span of control adequate? 控制范围是否适当、充分？ What is the ratio of supervision to analyst? 分析员监督比率是多少？ Are the roles and responsibilities for each position clearly defined? 每一个岗位（或职位）的作用与职责是否被明确的规定？ Are job descriptions available? 是否有职位说明？