上海金冀商务咨询有限公司, Shanghai Jinji Business Consulting Co., Ltd文件编号：固体车间清洁验证方案Cleaning validation Master Plan for Solid Dosage Workshop立项部门： 质量保证部Initiation Department: Quality Assurance Department工艺验证小组负责人： Leader of validation teem:方案制订日期： 年 月 日 Date: Year Month Day- 1 -目 录List of Content一.验证概述OVERVIEW OF VALIDATION二.验证组织机构及人员安排VALIDATION ORGANIZAGION AND MEMBERS三.应用范围AREAS OF APPLICATION四.风险评估RISK EVALUATION五 验证方案表格VALIDATION MATRIX六 清洁溶剂CLEANSING AGENTS七.可接受标准的确定ACCEPTANCE CRITERIA八.清洁验证取样CLEANING VALIATION AND SAMPLING九清洁验证的实施IMPLEMENTATION OF CLEANING VALIDATION 十. 偏差、变更DEVIATIONS AND CHANGES十一.再验证RE-VALIDATION一. 验证概述 Overview of Validation1. 验证目的根据GMP的要求，在口服固体制剂生产结束后，要对生产设备及操作间进行彻底清洁，以避免造成不同批号或不同品种产品之间的污染和交叉污染。根据各生产设备的操作、清洁及维护保养标准操作规程，进行风险分析，选出最坏情况产品。为了验证清洁方法的稳定性与可靠性，对所选的最坏产品进行三次清洁验证。每批产品生产结束后，对所有在生产中使用的生产设备及容器具进行清洁，清洁后取样检测化学残留及微生物残留，要求残留量低于设定的残留限度要求。According to requirements of GMP, the manufacturing equipments and rooms must be completely cleaned to avoid contamination of different batches of same products or cross-contamination of different products after manufacturing of oral solid dosage. There are two types of cleaning method based on SOPs of Operation/ Cleaning and maintenance for individual equipments: implement the risk analysis assessment to choose the worst case products. Three consecutive cleaning validation will be conducted to validate the stability and reliability of cleaning method. All equipments and utensils used in manufacturing must be completely cleaned once every batch of the worst case products are finished, then sample to test chemical residual and microbial residual, the requirement is the level of residual is less than the limit of residual.二.验证组织机构及人员安排 Validation Organization and Team Members2.1制造部/Production Dept.组织清洁验证方案及报告的起草；Prepare the cleaning validation protocol/report确定设备表面积、清洁方法、取样部位；Determine the surface area of equipments, cleaning method and sampling locations制定清洁操作规程；Establish cleaning procedure按清洁操作规程清洁设备和容器具；Clean equipments and utensils according to cleaning procedure确保清洁记录填写完整；Make sure the completeness of cleaning records将完成的清洁验证文件提交给QA审查；Submit the finalized cleaning documentation to QA review2.2质量保证部/QA Dept. QC审核清洁验证方案/报告；Review the cleaning validation protocol/report 制定清洁验证取样方法和检测方法； Establish sampling method and analytical method of cleaning validation对清洁后设备、容器具进行取样和检测，报告检验结果；Sample and test cleaned equipments and utensils, then report the testing results.使用在校验有效期内的仪器设备进行检测。 Use those instruments within calibration expired dateQA制定清洁验证计划及验证编号；Establish cleaning validation plan and No.负责组织审核清洁验证的方案/报告；Organize the review the cleaning validation protocol/report组织清洁验证相关部门进行清洁验证方案的培训并记录；Organize the training and record for cleaning validation protocol 负责验证实施过程的协调，保证验证项目实施进度；Coordinate the activities of cleaning validation to ensure the performance.验证实施中的监控检查；Supervise the validation activities.保证经验证的参数符合预期的标准；Make sure validated parameters meet pre-determined criteria负责组织验证方案中改变控制、偏差处理的调查；Organize the investigation for the change control and deviation handling.负责将完成的清洁验证文件归档。Archive the completed cleaning validation documentation质量保证部经理：QA Manager批准清洁验证方案、验证报告。Approve the cleaning validation protocol and report2.3设备动力部/Engineering Dept.保证清洁验证过程中，所用到的仪器仪表在校验有效期内；Ensure the instruments and meters involved in the cleaning validation have been calibrated and within calibration due date.保证验证过程中空调、纯化水、压缩空气、热水等的供应，确保清洁验证的实施。Ensure the normal working order and operation of HVAC, purified water system, compressed air, hot water for the cleaning validation.2.4清洁验证小组人员名单/Team Member List组 长 Team Leader部门 Dept.岗位 Position姓名 Name制造部 Production Dept.业务经理 Supervisor小组成员 Team Member部门 Dept.岗位 Position姓名 Name设备动力部 Engineering Dept.业务经理 Supervisor制造部 Production Dept.工艺质量员 Technician制造部 Production Dept.生产协调员 Production Coordinator制造部 Production Dept.工艺质量员Production Coordinator制造部 Production Dept.工段长 Team leader制造部 Production Dept.技术员 Technician制造部 Production Dept.工段长 Team leader制造部 Production Dept.技术员Technician制造部 Production Dept.工段长 Team leader制造部 Production Dept.技术员Technician制造部 Production Dept.工段长 Team leader制造部 Production Dept.技术员TechnicianQCQC主管 QC SupervisorQC理化1组组长Leader of physicochemical team 1QC微生物组组长Leader of Microbial teamQC微生物检验员AnalyzerQAQA检查员 QA inspectorQAQA检查员 QA inspectorQAQA检查员 QA inspectorQA验证管理员Validation administrator三 应用范围Areas of application 本清洁验证主计划应用于固体车间所有产品。见产品列表The validation master plan is applied to all the products in the solid workshop. 产品名称Product name主成分AP