制药企业实验室FDA检查列表(check list).pdfVIP

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 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？ 共45页第1页  Are signature authority, responsibility, and accountabilities appropriate and clearly defined? 签名权力、责任、适当的问责制是否有明确地规定？  Do systems exist to enhance communication, understanding, and working relationships between Laboratory and QA personnel? 在实验室与QA 之间是否有加强信息沟通、理解以及工作关系的程序？  Does a personnel performance evaluation system exist which tracks Laboratory Personnel strengths and weakness and establishes corrective action procedures to Mitigate any weakness ？ 是否有人员业绩评估程序，跟踪实验室人员的优势和劣势，建立矫正行动程序，减轻任何弱点？  Does a master testing schedule or similar document(s) exit to insure smooth workflow, and minimize Laboratory personnel over commitment? 是否有用以保证顺利工作流程，最小化实验室人员上面的的承诺的主要试验大纲或类似的文件(s) ？  Do current CVs and resumes e