制药企业实验室FDA检查列表(check-list).docVIP

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？ 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 exist for all personnel including consultants?是否有所有员工包括顾问的个人简历？ Training培训 Have the educational, training and work experience requirements for each laboratory position been clearly defined and do they reflect current standards in the industry?对于每一个实验室岗位的教育、培训和工作经验强化培训计划需求是否有明确的规定？对于行业中的现行标准，他们是否可以反映？ Are training requirements clearly documented in a SOP. (Including Managers, Supervisors, Analysts and Temporary