验证概况和主计划.pptVIP

验证Validation 验证 Part 1的主旨 Objectives of Part 1 介绍验证的主题 To provide an introduction to the subject of Validation 介绍验证主计划的相关信息 To provide information on the Validation Master Plan 验证 介绍 Introduction 质量保证体系的3个基本原则: Three basic principles of Quality Assurance: 质量可控, 安全性, 有效性 Quality, safety, effectiveness 质量是生产出来的，不是检验和检查出来的 Cannot inspect quality into a product 药品生产的全过程必须被控制 Processes must be under control 验证 WHO 验证定义 validation definition 证明任何程序、工艺、设备、物料、活动或系统能导致预期结果的有文件记录的一系列活动。 The documented act of proving that any procedure, process, equipment, material, activity, or system actually leads to the expected results.? 验证 确认或验证? Qualification or validation? 一个系统用于被验证过的工艺时必须先进行确认。 A system must be qualified to operate in a validated process 确认一个系统和/或设备 Qualify a system and/or equipment 验证一个工艺 /方法 Validate a process/method 确认VS验证, 譬如：你确认一个高压灭菌锅，而你要同时验证了一个灭菌工艺。 Qualification versus validation, e.g. you qualify an autoclave, whereas you validate a sterilization process Who Validates? First Three Steps To CGMP Compliance Document Document Document Write Protocols Example Data Sheets Conduct Testing How Do We Validate? Validation Life Cycle Approach Validation Life Cycle Approach 举例-----泡茶 茶叶品种（供应商） 茶叶重量（投料量） 茶杯种类（设备） 水质（工艺用水） 加水量（反应浓度） 水温 浸泡时间 Benefits of Validation验证带来的好处 Increased Throughput增加产能 Reduction In Rejections and Reworks减少返工和再加工 Reduction In Utility Costs降低公共系统费用 Avoidance Of Capital Expenditures降低基建费用 Fewer Complaints About Process Related Failures减少工艺相关的投诉 Reduced Testing – In-process and Finished Goods减少检验(在线和产品检验） More Rapid / Accurate Investigations Into Process Upsets工艺事故调查更快更准确 More Rapid and Reliable Startup Of New Equipment更快更可靠地使用新的设备 Easier Scale-up From Development Work更容易完成研发到生产的工艺放大 Easier Maintenance Of The Equipment设备保养更容易 Improved Employee Awareness Of Processes增进员工对工艺的理解 More Rapid Automation更容易进行自动控制 验证 确认和验证工作需要: Qualification and validation work require: 和专家协作 Collaboration of experts 预算 Budget