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1、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 superviso
2、r 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
3、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
4、 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
5、 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
6、人员上面的的承诺的主要试验大纲或类似的文件 s Do current CV s 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
7、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 staff 培训需求在 SOP中是否有明确的规定 包括经理 管理者 分析员以及临时员工 Has a training curriculum been developed for each position which clearly identifies all require
8、d SOPs and Policies safety cGMPs as well as all other internal and external courses or programs Database or hard copy 每个位置需要的 SOPS 策略 安全 cGMPs 以及所有其他的内部和外部的课程或者方案 数据库 或硬拷贝 的培训课程是否被开发 Is job specific training identified 仅限于工作的培训鉴定了吗 Does each employee have a training file 每位员工是否都有培训文件 资料 Are the trai
9、ning histories for each individual current Database or hard copy 当前的每位员工是否都有培训历史 数据库或硬拷贝 Have all laboratory personnel been properly trained 所有试验人员是否得到适当的培训 Is this training documented and where do these documents reside 是否有培训记录 并存档 How is SOP training conducted 如何实施 SOP培训 Are metrics used to determ
10、ine acceptability 是否有可接受的标准 Is there a laboratory certification program 是否有实验室认证程序 Has an individual been designated as the training coordinator or manager 是否有固定的培训协调员或经理 Is there evidence or rmanagement support for training and training programs 是否有培训和管理培训方案的程序文件 Does a formal training budget exist
11、 是否有一个正式的培训 经费 预算 Do vendor training records exist 是否有供应商培训记录 Is there evidence that newly hired employees are evaluated for skill level and competency 是否有证据表明新聘用的员工是经过技术水平和能力的评估 Is there a formal training schedule in place and is being executed 是否有一个正式的培训计划并正在执行 Is there evidence of employee re tra
12、ining 是否有员工再培训的证据 Is there a positive attitude with respect to training on the part of Management and Laboratory personnel 关于对实验室的管理和人员培训这部分是否有一个积极的态度 Change Control 变更控制 Is there a current Change Control system and written procedure for authorization documentation and implementation of changes that
13、 may have a regulatory or quality impact 是否有经批准的日常变更控制系统和诉讼的书面程序 是否有变更执行后的监管或对质量的可能影响 Who is responsible for administration and approval of Change Control system 谁负责管理变更控制系统 谁负责审批变更控制系统 Is there a tracking system for changes 是否有变更跟踪系统 Does the Change Control system include mechanisms for planned cha
14、nges to 变更控制系统是否包括对计划的变更机制 Standard Operating Procedures 标准操作规程 SOP Formulation 处方 Manufacturing Process 生产过程 Major Equipment 主要设备 Batch Size 批量 Production Site 生产地点 Raw Material or Packaging Material Supplier Process 原 辅 料和包装材料的供应商及生产过程 Testing Methods 测试方法 Product Specifications 产品规格 Raw and Packa
15、ging Material Specification 原 辅 料和包装材料明细表 Changes in Regulatory Requirements 变化的监管要求 Defining Major and Minor Changes 定义主要和次要的变化 How are unplanned changes made 无计划的变更是如何发生的 Who approves those changes 谁批准这些变更 Communications Reports 通信 报告 Does the lab conduct statistical quality control 实验室是否进行统计质量控制
16、How is this information communicated 此信息是如何传达的 Are lab OOS results trended 实验室 OOS 结果的趋势如何 Is there a system to inform QA of negative trends 这个系统在通知 QA 的过程中是否有消极的趋势 Is management notified in a timely manner of all laboratory rejections and negative trends 在拒绝了所有实验室和消极的趋势后 是否及时的通知了管理人员 Is the information on OOS lot rejections etc supplied in a timely fashion for Annual Product Reviews 在年度产品回顾中 是否有OOS 的信息 包括供应商 Are laboratory operations audited routinely 是否有实验室操作常规审计 What is the frequency 频率是什么 Ar
