ICH Q7A(GMP中英文)原料药优良制造规范指南.doc

ICH?Q7A(GMP中英文)原料药的优良制造规范指南 原料药的优良制造规范（GMP）指南 ICH三方协调指南 ICH指导委员会2000年11月10日的会议按ICH规程第4步 建议ICH的三个药政部门采用本指南 目?????录 1?引言INTRODUCTION 6 1.1?目的Objective 6 1.2?法规的适用性?Regulatory?Applicability 7 1.3?范围?Range 7 2?质量管理?QUALITY?MANAGEMENT 8 2.1?原则?Principles 8 2.2?质量部门的职责?Responsibilities?of?the?Quality?Unit(s) 9 2.3?生产作业的职责?Responsibility?for?Production?Activities 12 2.4?内部审计（自检）?Internal?Audits?(Self?Inspection) 13 2.5?产品质量审核?Product?Quality?Review 13 3?人员?PERSONNEL 13 3.1?员工的资质?Personnel?qualifications 14 3.2?员工的卫生?Personnel?Hygiene 14 3.3?顾问?Consultants 15 4?建筑和设施?BUILDINGS?AND?FACILITIES 15 4.1?设计和结构?Design?and?Construction 15 4.2?公用设施?Utilities 16 4.3?水?Water 17 4.4?限制?Containment 17 4.5?照明?Lighting 18 4.6?排污和垃圾?Sewage?and?Refuse 18 4.7?清洁和保养?Sanitation?and?Maintenance 18 5?工艺设备?PROCESS?EQUIPMENT 19 5.1?设计和结构?Design?and?Construction 19 5.2?设备保养和清洁?Equipment?Maintenance?and?Cleaning 20 5.3?校验?Calibration 21 5.4?计算机控制系统?Computerized?Systems 21 6?文件和记录?DOCUMENTATION?AND?RECORDS 22 6.1?文件系统和规格?Documentation?System?and?Specifications 22 6.2?设备的清洁和使用记录Equipment?Cleaning?and?Use?Record 24 6.3?原料、中间体、原料药的标签和包装材料的记录?Records?of?Materials?,?Intermediates,?API?Labeling?and?Packaging?Materials 24 6.4?生产工艺规程Master?Production?Instructions 25 6.5?批生产记录Batch?Production?Records 25 6.6?实验室控制记录?Laboratory?Control?Records 27 6.7?批生产记录审核?Batch?Production?Record?Review 28 7?物料管理?MATERIALS?MANAGEMENT 28 7.1?控制通则General?Controls 28 7.2?接收和待验?Receipt?and?Quarantine 29 7.3?进厂物料的取样和测试?Sampling?and?Testing?of?Incoming?Production?Materials 30 7.4?储存?Storage 31 7.5?重新评估?Re-evaluation 31 8?生产和中间控制?PRODUCTION?AND?IN-PROCESS?CONTROLS 31 8.1?生产操作?Production?Operations 31 8.2?时间限制?Time?Limits 32 8.3?工序间的取样和控制?In-process?Sampling?and?Controls 33 8.4?中间体或原料药的混合?Blending?Batches?of?Intermediates?or?APIs 34 8.5?污染的控制?Contamination?Control 35 9??原料药和中间体的包装和贴签??PACKAGING?AND?IDENTIFICATION?LABELING?OF?APIs?AND?INTERMEDIATES 35 9.1?总则?General 35 9.2?包装