固体车间清洁验证的方案.docVIP

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 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  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  验证概述 Overview of Validation 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 Members 2.1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 locati