Q7Step4 原料药生产的GMP指南.doc

INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ICH Harmonised Tripartite Guideline Good Manufacturing Practice Guide forActive Pharmaceutical Ingredients Q7 Current Step 4 version dated 10 November 2000 This Guideline has been developed by the appropriate ICH Expert Working Group and has been subject to consultation by the regulatory parties, in accordance with the ICH Process. At Step 4 of the Process the final draft is recommended for adoption to the regulatory bodies of the European Union, Japan and USA.  Q7Document History First Codification History Date New Codification November 2005 Q7A Approval by the Steering Committee under Step 2 and release for public consultation. 19July2000 Q7 Current Step 4 version Q7A Approval by the Steering Committee under Step 4 and recommendation for adoption to the three ICH regulatory bodies. 10 November 2000 Q7 Good Manufacturing Practice Guide forActive Pharmaceutical Ingredients ICH Harmonised Tripartite Guideline Having reached Step 4 of the ICH Process at the ICH Steering Committee meeting on 10 November 2000, this guideline is recommended for adoption to the three regulatory parties to ICH TABLE OF CONTENTS 1. INTRODUCTION 1 1.1 Objective 1 1.2 Regulatory Applicability 1 1.3 Scope 1 2. QUALITY MANAGEMENT 4 2.1 Principles 4 2.2 Responsibilities of the Quality Unit(s) 4 2.3 Responsibility for Production Activities 5 2.4 Internal Audits (Self Inspection) 5 2.5 Product Quality Review 6 3. PERSONNEL 6 3.1 Personnel Qualifications 6 3.2 Personnel Hygiene 6 3.3 Consultants 7 4. BUILDINGS AND FACILITIES 7 4.1 Design and Construction 7 4.2 Utilities 8 4.3 Water 8 4.4 Containment 8 4.5 Lighting 9 4.6 Sewage and Refuse 9 4.7 Sanitation and Maintenance 9 5. PROCESS EQUIPMENT 9 5.1 Design and Construction 9 5.2 Equipment Maintenance and Cleaning 10 5.3 Calibration 11 5.4 Computerized Systems 11 6. DOCUMENTATION AND RECORDS 12 6.1 Documentation System