行业指南-注射产品中可见颗粒的检查中英文对照.doc

行业指南-注射产品中可见颗粒的检查中英文对照 TABLE OFCONTENTS目录 I. INTRODUCTION介绍 II. STATUTORY AND REGULATORY FRAMEWORK法律法规框架 III. CLINICAL RISK OF VISIBLE PARTICULATES 可见颗粒物的临床风险 IV. QUALITY RISK ASSESSMENT 质量风险评估 V. VISUAL INSPECTION PROGRAM CONSIDERATIONS 目视检查的程序考虑 A. 100% Inspection 100%检查 1. Components and Container Closure Systems 部件和容器密封系统 2. Facility and Equipment 设施和设备 3. Process 工艺 4. Special Injectable Product Considerations 特殊注射产品的考虑 B. Statistical Sampling 统计学抽样 C. Training and Qualification 培训和确认 D. Quality Assurance Through a Life Cycle Approach 通过生命周期方法实现质量保证 E. Actions To Address Nonconform