化学仿制原料药DMF样本.docx

此内容仅作为医药研发工作者撰写 DMF 文件时研究参考使 用，仅作为学术交流用途。 *** (Name of Drug Substance) DRUG MASTER FILE MODULE:3 *** Pharmaceutical Co.,Ltd. *********, *,China, ****** Telephone:86-***-******** Fax:86-***_******** March 27,2018 Tabtle3-2-1 TABLE OF CONTENTS Section Title Page No. 3.2.S DRUG SUBSTANCE 3.2.S.1 General Information 3.2.S.1.1 Nomenclature 3.2.S.1.2 Structure 3.2.S.1.3 General Properties 3.2.S.2 Manufacture 3.2.S.2.1 Manufactures 3.2.S.2.1.1 Brief Introduction of Manufacturer 3.2.S.2.1.2 Contact Information of Manufacturer 3.2.S.2.1.3 Organization Chart 3.2.S. Organization Chart 3.2.S. Quality Management Team 3.2.S.2.2 Description of Manufacturing Process and Process Controls 3.2.S.2.2.1 Route of Chemical Reaction 32S.2.2.2 Process Flow Diagram 3.2.S.2.2.3 Procedures of Manufacturing Process 3.2.S.2.3 Control of Materials 3.2.S.2.3.1 General Information 3.2.S.2.3.2 Control of Starting Materials 3.2.S.2.3.3 Control of Reagents,Solvents,and Auxiliary Materials 3.2.S.2.4 Control of Critical Steps and Intermediates 3.2.S.2.4.1 Control of Critical Steps 3.2.S.2.4.2 Control of Intermediates 3.2.S.2.5 Process Validation and Evaluation 3.2.S.2.5.1 Process Validation Plan 3.2.S.2.5.2 Results of Process Validation 3.2.S.2.6 Manufacture Process Development 3.2.S.2.6.1 Route Selection and Process Optimization 3.2.S.2.6.2 Determination of Critical Process 3.2.S.2.6.3 Process Scale-up Research 3.2.S.3 Characterization 3.2.S.3.1 Elucidation of Structure and other Characteristics 3.2.S.3.1.1 Elucidation of Structure 3.2.S.3.1.2 Other Characteristics 3.2.S. Specific Optical Rotation 3.2.S. Melting Point 3.2.S. Solubility 3.2.S. Hygroscopicity 3.2.S. Particle Size 3.2.S. Microbiological Test 3.2.S. Polymorphism 3.2.S. Solvate and/or Hydrate 3.2.S. Spatial Configuration 3.2.S.3.2 Impurities 3.2.S.4 Control of Drug Substance 3.2.S.4.1 Specification 3.2.S.4.2 Analytical Procedures 3.2.S.4.3 Validation of Analytical Procedures 3.2.S.4.3.1 Analytical Method Validation of Assay 3