2024整理-API开发生产和法规volume151质量控制和保证中英

7Quality Assurance and Control 质量保证和质量控制MICHAEL C. VANDERZWANPharmaceutical Technical, Roche Pharmaceuticals, Basel, SwitzerlandI. Introduction 介绍 . . . . . . . . . . . . . . . . . . . . . . . . . . . 235II. Defining and Assuring the Quality of the Active Pharmaceutical Ingredient原料药质量的定义和保证 . . . . . . . . . . . . . . . . . . 240III. The Regulations for Quality 质量监管. . . . . . . . . . . . . . . . . 245IV. The Quality Control and Quality Assurance Department质量控制和质量保证 . . . . . . . . . . . . . . . . .273Appendix A 附录 . . . . . . . . . . . . . . . . . . . . . . . . . . . 280目录I. INTRODUCTION 介绍.............................................................................................2A. The Product 产品...................................................................................................3B. The Process 工艺...................................................................................................4C. The Facilities 设备.................................................................................................5D. The People 人员....................................................................................................5E. The Quality Management Department 质量管理部门..........................................6F. The Regulatory Authorities 监管机构...................................................................7G. The Regulations 法规............................................................................................7II. DEFINING AND ASSURING THE QUALITY OF THE ACTIVE PHARMACEUTICAL INGREDIENT 原料药质量的定义和质量保证.................9A. Defining the API Quality 原料药质量的界定....................................................10B. Testing the API for Its Defined Attributes 原料药定义...