分享|清洁验证关键点
前提条件
在制订验证方案前需准备的文件包括:
- Validationstrategy, including rationale for product and/or equipment grouping验证策略,包括产品和/或设备分组的基本原理
- Draft cleaningSOP, including CPPs清洁SOP 草案,包括关键工艺参数
- Acceptancecriteria and how those criteria were established可接受标准,以及这些标准建立的依据
- Analyticalmethods and their validation使用的分析方法和分析方法的验证
- Samplingmethods and sampling sites (locations)取样方法和取样点(位置)
- Samplingrecovery studies取样回收率的研究
- Selection of protocolchallenges, including hold times挑战方案的选择,包括保持时间
- Rationale forthe selection of number of validation (PPQ) runs验证(PPQ)运行次数选择的理由
- How equipmentcleaning is to documented设备清洁的记录方法
- Responsibilitiesfor execution of the protocol方案执行的责任
- Training ofoperators, samplers and analysts on applicable procedures操作者、取样人员和分析人员的培训记录
- Plans forvalidation maintenance验证维护计划
- Plansfor equipment and product disposition during the protocol execution.方案执行过程中设备和产品的处置计划
- Cleaning agent清洁剂
- Concentration浓度
- Contact time接触时间
- Temperature温度
- Product characteristics产品性质
- Product condition产品状态
- Automated cleaning pathways自动化的清洗方法
- The sequence of manual or automatedcleaning steps各手工或自动化清洁步骤的顺序
- Flow rates during each step每一步骤时的流速
- 10ppm;
- 日剂量1/1000;
- 基于毒理学数据的计算;
- 不同给药途径,不同用药人群,如儿童和老人,不同清洗难易程度的设备表面,专用与多用途设备的不同考虑。
- Direct surface sampling直接表面取样
- Rinse sampling冲洗取样
- Swabbing擦拭法
- Placebo sampling.安慰剂取样法
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