原料药生产申报支持性文件的递交指南.doc

GUIDELINE FOR SUBMITTING SUPPORTINGDOCUMENTATION IN DRUG APPLICATIONS FOR THEMANUFACTURE OF DRUG SUBSTANCES Center for Drug Evaluation and ResearchFood and Drug AdministrationDepartment of Health and Human Services February 1987 For further information regarding the guideline please contact:  Food and Drug AdministrationCenter for Drug Evaluation and ResearchOffice of Drug Evaluation I (HFD-100)5600 Fishers LaneRockville, Maryland 20857(301-443-4330) Note:This Guideline was prepared by Dr. Arthur Shaw, Food and Drug Administration, for a Course offered by the Center for Professional Advancement in March of 1994. There have been no changes in the text from the printed version of the Guideline. However the text has been reformatted to reduce the number of pages. The Table of Contents reflects the new pagination. The old pagination is noted in the Guideline. 原料药生产申报支持性资料的递交指南 健康与人类服务部 食品药品管理局 药品评估与研究中心 1987年2月 有关指南的更多信息，请联系： 5600 Fishers LaneRockville, Maryland 20857(301-443-4330)食品药品管理局 药品评估与研究中心 药品评估办公室1 (HFD-100) 注：本指南是食品药品管理局的Arthur Shaw博士于1994年为职业进修中心提供的一门课程而编写。指南的印刷版正文未曾有变更。但是正文经过重新排版，减少了页数。目录显示了新的页码。老的页码也在指南中注明。 TABLE OF CONTENTS 目录 I. INTRODUCTION 介绍 6 II. REQUIREMENTS FOR A NEW DRUG APPLICATION 新药申请的要求 7 A. Physical and Chemical Characteristics 物理和化学特征 7 1. Properties 性质 7 2. Structure 结构 8 B. Stability 稳定性 9 C. Name and Address of the Manufacturer 生产商的名称与地址 9 D. Manufacture of the Drug Substance 原料药的生产 9 1. Material Controls 物料的控制 10 a. Starting materials 起始物料 10 (1) Definition of starting material 起始物料的定义 10 (2) Control procedures for starting materials 起始物料的控制程序 11 b. Reagents, solvents, and auxiliary materials controls 试剂、溶剂与辅料的控制 12 2. Synthetic Drug Substance 合成原料药 12 a. Flow chart of the synthesis 合成的流程图 12 b. Description of the synthesis 合成过程的描述 13 c. Purification of the drug substance 原料药的精制 14 d. Changes in the synthesis 合成过程的变更 15 3. Reference Standard 对照品 17 4. In Situ Products (not isolated) 原位产品（没