制药行业过程自动化及法规遵从.pptVIP

Regulatory Complianceand Validation Services  Glossary FDA = Food and Drug Administration, USA cGMP = Current Good Manufacturing Practices GAMP = Good Automated Manufacturing Practice Validation Establishing documented evidence that provides a high degree of assurance that a process, system, equipment or assay will consistently produce the desired results according to predetermined specifications and quality attributes CFR = Code of Federal Regulations, USA Regulatory Compliance and Validation Services Introduction Computer Systems Validation Automation Systems Validation Computer Infrastructure Qualification Electronic Records and Electronic Signatures Spreadsheet Validation Business Systems Validation Facility and Equipment Validation Education and Training Validation Outsourcing 法规遵从服务的需求 在世界范围内，生命科学制造商都要面对严格的政府管制 制药、生物技术和医疗设备制造商必须遵守国家规范和国际规范 益处: 提高产品安全性 确保消费者身体健康 挑战 市场变化和技术更新 如何平衡产业不断发生的变化并在应用新技术的同时满足遵从规范解决方案的要求 时间和资源的短缺 如何利用有限的时间和资源，以保持与规范发展同步，始终做好被检查的准备 一定的质量产品和好的价格 如何在严峻的经济条件下满足客户对于质量优质,价格适宜标准的要求 Validation: “Documented Evidence …” Regulatory Compliance and Validation Services Introduction Computer Systems Validation Automation Systems Validation Computer Infrastructure Qualification Electronic Records and Electronic Signatures Spreadsheet Validation Business Systems Validation Facility and Equipment Validation Education and Training Validation Outsourcing 计算机系统验证(CSV) 计算机及其应用能否按照预想和根据规定和规范的要求进行工作 ? 计算机数据能否受到保护，杜绝未经授权访问、修改数据以及不经意损坏数据? 计算机系统验证(CSV) ABB验证服务涵盖： 验证主规划VMP 风险评估 可追溯性方案 用户要求说明书 功能要求说明书 ? 源代码检查 ? 安装确认(IQ) ? 运行确认(OQ) ? 性能确认(PQ) ? 标准操作程序(SOP) ? 验证文件 ? 培训 Automation Systems Validation Standardization through GAMP: Good Automated Manufacturing Practice Guide for Validation of Automated Systems Tailored specifically to automation systems Establishes validation deliverables Provides common language and terminology Procedural task flow for project implementation and maintenance Validation Life Cycle (GAMP) GAMP Life Cycle Documents U