《一份较完整的DMF文件》.doc

Table of Contents Section Page A. Administrative Information 1. Drug Master File Holder 1 2. Corporate Headquarters 1 3. Manufacturing Facility 1 4. Stability Testing Facility 3 5. Responsible Official or Agent 3 6. Statement of Commitment 4 B. Organization and Personnel 1. Key Personnel and Their Responsibilities 5 2. Consultants 10 3. Contract Laboratories 11 C. Buildings and Facilities 1. General Design and Construction Features 12 2. Facility Maintenance 17 D. Equipment 1. Design and Location 18 2. Calibration and Maintenance 21 E. Physical and Chemical Characteristics 1. Introduction 22 2. Description 22 3. Physical and Chemical Characteristics 24 4. Structure Elucidation 25 F. Manufacture of XX Drug Substance 1. Materials Control 45 2. Isolation and Purification 59 3. Manufacture of Reference Standard 81 4. Reprocessing and Reworking 82 G. Process Controls 1. Quality Control of InProcess Materials 83 2. Analytical Methods for InProcess Materials 88 Table of Contents (continued) Section Page H. Controls of XX Drug Substance 1. Sampling 113 2. Release Controls 114 3. Controls for Reference Standard 175 4. Packaging and Labeling 177 5. Lot Numbering System 180 I. Stability Protocol for XX Drug Substance 1. Stability Testing Facility 181 2. Stability Protocol 181 3. Stability Results 184 4. Conclusions 194 J. Environmental Assessment 195 Appendix I: Literature References 196 A. Administrative Information 1. Drug Master File Holder YY Technological Development Co. Ltd. YY TechZone,ZZ Hill, Beijing, P.R. China 100033 2. Corporate Headquarters YY Technological Development Co. Ltd. YY TechZone,ZZ Hill, Beijing, P.R. China 100033 Contact Person:QiaoYing Ta Tel: 0118600053219583 (office) 0118600053219643 (receptionist) Fax: 0118600053219081 3. Manufacturing Facility YY Technological Development Co. Ltd. YY TechZone,ZZ Hill, Beijing, P.R. China 100033 Contact Person: QiaoYing Ta Director of QA and QC Tel: 0118600053219583 (office) 01186