全球质量经理的培训教材(编辑修改稿)

全球质量经理的培训教材(编辑修改稿)内容摘要：

不利方面的考虑（严重的损伤或死亡）  Additional requirements apply to plaints alleging serious injury or death (21 CFR 803) 正对严重损伤或死亡的申诉的额外要求（ 21CFR803) What About Complaint Files? 投诉文件 33  A pilation of records containing the production history of a finished device. 记录需包含每个成品的生产历史  A DHR includes DHR包含  Dates of manufacture 生产日期  Quantity manufactured and released 数量和生产  Acceptance records 可接受记录  Primary identification label 主要确认标记  Device identification and lot number 产品确认和生产标号 What is a DHR?DHR是什么。 34  Maintained at the manufacturing site or otherwise reasonable  Legible and plete (errors must be appropriately corrected) 易读的和完成的（错误必须适当纠正）  Retained for the life of the product (minimum 2 years from date of release).产品寿命需维持从生产日期起至少 2年）  Exceptions include Management Review, Quality Audits and Supplier ，质量审核和供应商审核 Record Requirements 记录要求 35  Additional requirements  Electronically stored – must be backed up  Electronically created – must ply with Part 11 requirements  Electronically signed – must ply with Part 11 requirements  CSV Roadmap VFlow/CSV%  额外要求  电子储藏 必须后备  电子生成 必须与 11章节要求一致  电子签署 必须与 11章节要求一致  CSV路径VFlow/CSV% Electronic Record Requirements 电子记录要求 36 Design Verification and Validation, Process Validation 设计及方法确认和批准  Design Verification and Validations  Must verify design “Output” meets “Input”.  Must validate design under normal operating conditions with production product.  Design validation must Risk assessments.  设计的确认和批准  必须确认设计从生产和出产的一致  必须在常规产品生产操作的情况下批准设计  设计批准必须经过风险评估  Process Validations 方法批准  Where results of a process can not be verified, a process shall be validated, ., bioburden, cleaning, sanitization, etc. 当 一种方法的结果不被查证时， 37 Change Requirements 改动要求 Change control process for the identification, documentation, validation, or where appropriate verification, review and approval of changes before implementation. 改变控制进程是在改变实施之前，针对改变的，审阅，查证，认可随后做出相应的审批，法律批文和文档的过程。 These changes include, but are not limited to: 这些改变包含以下方面但不仅限于此：  Design 设计  Process 进程  Software 软件  Cleaning 清洁  Sanitization 清除干净 38 GMP Controls What needs to be in place? 什么适当的方面需要 GMP控制  Understand the scope, risk and regulations  Assess risks – HACCP  Product History  领会范围，风险及规章  评估风险 HACCP 危害分析关键控制点  产品历史 39 Risk Assessment Scope 风险评估范围 40 How do we assess GMP risks? 我们如何评估 GMP风险。 HACCP is a proactive systematic approach to the identification, assessment of risk and severity, and control of biological, chemical, and physical hazards/contamination associated with a product, production process or practice. HACCP是一种较有体系的方法，使产品在生产实践过程中，对产品生物化学物理技能等方面的风险及严肃性的审查及评估。 41 Why use HACCP? 为何适用危害分析关键控制点 It’s all about making Safe and Clean products and meeting Good Manufacturing Practices!!! 一切都是为了生产安全整洁的产品  Regulatory requirements 调整要求  Competitive advantage for identification of design issues early 设计版本及早的确认具有竞争性的优势  Protection for product liability awards 产品审查责任的保护  Learn about HACCP as a tool for assessing contamination risks 学习 HACCP作为评价混淆风险的工具 43 GMP Next Steps GMP下阶段  Impact on North Asia  Korea  China  Taiwan  对北亚的影响  韩国  中国  台湾  Plans for implementation 计划实施  Training 培训  Project Management 项目管理 44 The 3 Keys to Success with GMP’s GMP’s成功的三点关键 1. Critical Start – Infrastructure and Systems 2. Avoid Surprises – Communicate and plan Early 3. Product – Design, Development, Process and Approvals 4. 开始评论 构造和体系 5. 避免意外事件 及早沟通与计划 6. 产品 设计，发展进程和认可 45 Resources 资源  GRSA  Regulatory Affairs  CART (Compliance and Resource Team)  Global Capability Teams  Business Quality Leaders  规程  CART（资源团队）  全球力量团队  商业质量领导 46 Questions 问题 47 Appendix A 附录 A  Cosmetic and Drug GMP‟s  美容及药品生产质量操作规范 48 Cosmetic / Drug GMP’s 美容及医药生产质量操作管理规范  Buildings and Facilities 生产场地及设备  Buildings used in the manufacture or storage of cosmetics are of suitable size, design and construction to permit unobstructed placement of equipment, orderly storage of materials, sanitary operation, and proper cleaning and maintenance.  Floors, walls and ceilings are constructed of smooth, easily cleanable surfaces and are kept clean and in good repair.  Fixtures, ducts and pipes are installed in such a manner that drip or condensate does not contaminate cosmetic materials, utensils, cosmetic contact surfaces of equipment, or finished products in bulk.  生产场地是指用于合适尺寸，设计的美容产品的生产和储存，并用于设备的堆放，日常原料的储存，卫生的操作以及适度的清洁和维护。  地板，墙壁和天花板必须平整的建筑，并较易的可做表面清洁和良好的维修。  装置物，电线以及管道等必须被合理安装，以避免有房屋渗漏现象导致机械表面，箩筐里面的成品的破损。 49 Cosmetic / Drug GMP’s美容及医药生产质量操作管理规范  Buildings and Facilities (continued)  Lighting and ventilation are sufficient for the intended operation and fort of personnel.  Water supply, washing and toilet facilities, floor drainage and sewage system are adequate for sanitary operation and cleaning of facilities, equipment and utensils, as well as to satisfy employee needs and facilitate personal cleanliness.  照明以及通风必须足以使个人舒适和适应操作  水供给，洗手间设备，地面排水渠道和排污系统必须足以满足卫生操作和设备清洁也必须满足雇员个人的清洁 50 Cosmetic / Drug GMP’s美容及医药生产质量操作管理规范  Equipment 设备  Equipment and utensils used in processing, holding, transferring and filling are of appropriate design, material and workmanship to prevent corrosion, buildup of material, or adulteration with lubricants, dirt or sanitizing agent.  Utensils, transfer piping and cosmetic contact surfaces of equipment are wellmaintained and clean and are sanitized at appropriate intervals.  Cleaned and sanitized portable equipment and u。