De-mystifying GMP解疑GMP.pptVIP

GMP502. De-mystifying GMP解疑GMP Introduction 介绍 Quality Assurance, GMP and Quality Control 质量保证，GMP与质量控制 What is GMP ? 什么是GMP ? Legal Status of GMP GMP的法律地位 GMP : The Industry and the Regulators GMP：行业与法规制定者 Essential Elements of GMP： GMP的基本元素 Summary 摘要 Essential Messages 基本信息 MORAL and LEGAL Obligations of Manufacturers制造商的道德与法律责任 To organize their activities so that… 规范业界的行为以使得… Products are FIT FOR INTENDED USE 产品符合指定的用途 Comply with REGULATORY COMMITMENTS 遵守对法规的承诺 Patients not at risk because of inadequate: 防止由于以下的不当，使患者处于风险中: SAFETY安全 QUALITY质量 EFFICACY功效 EU Guide to GMP ...欧盟关于GMP的指南 ATTAINMENT of QUALITY OBJECTIVE 达到质量目标 Is responsibility of SENIOR MANAGEMENT 是高层管理者的责任 Requires PARTICIPATION and COMMITMENT by : 要求下列人员的共同参与及承诺: Staff in many Departments and at all levels多数的部门和各个级别的员工 The Company’s Suppliers公司的供应商 The Company’s Distributors公司的销售商 To Achieve the Quality RELIABLY there must be a ...要达到质量可靠性，必须有... COMPREHENSIVELY DESIGNED and CORRECTLY IMPLEMENTED system of QUALITY MANAGEMENT incorporating ... 全面设计的与正确实施的质量管理系统, 它综合了… ? QUALITY ASSURANCE 质量保证 GOOD MANUFACTURING PRACTICE良好操作规范（或称:生产质量管理规范） QUALITY CONTROL质量控制 Quality Assurance ...质量保证... The CREATION and OPERATION of : 建立并实施: STANDARDS 标准 PROCEDURES 过程 MANAGEMENT SYSTEMS管理系统 To GUARANTEE the QUALITY of a PRODUCT throughout its “LIFE CYCLE ” 保证产品在整个“生命期” 的质量 ALL FACTORS... inside and outside the factory 工厂内部的与外部的所有的因素... BEFORE, DURING AND AFTER MANUFACTURE 在生产之前，生产期间和生产之后 Good Manufacturing Practice 良好操作规范 Part of Quality Assurance aimedat ensuring that products are CONSISTENTLY MANUFACTURED to the REQUIRED QUALITY within the FACTORY 质量保证的一个目的是确保工厂按照要求的质量始终如一地生产合格的产品。 Quality Control... Part of GMP质量控制...GMP的一部分 Quality Control is Concerned With 质量控制涉及 Sampling programmes 采样程序 Specifications 规范 Testing 检测 PHYSICAL ? CHEMICAL ? BIOLOGICAL 物理的、化学的与生物方面的测试 Documentation 文件 Standards 标准 Release procedures 放