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1、GUIDELINE FOR SUBMITTING SUPPORTINGDOCUMENTATION IN DRUG APPLICATIONS FOR THEMANUFACTURE OF DRUG SUBSTANCESCenter for Drug Evaluation and ResearchFood and Drug AdministrationDepartment of Health and Human ServicesFebruary 1987For further information regarding the guideline please contact: Food and D
2、rug 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
3、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
4、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 . 6II. REQUIREMENTS FOR A NEW DRUG APPLICA
5、TION 新药申请的要求. 7A. Physical and Chemical Characteristics 物理和化学特征. 71. Properties 性质 . 72. Structure 结构. 8B. Stability 稳定性. 9C. Name and Address of the Manufacturer 生产商的名称与地址. 9D. Manufacture of the Drug Substance 原料药的生产. 91. Material Controls 物料的控制. 10a. Starting materials 起始物料. 10(1) Definition of s
6、tarting material 起始物料的定义. 10(2) Control procedures for starting materials 起始物料的控制程序. 11b. Reagents, solvents, and auxiliary materials controls 试剂、溶剂与辅料的控制. 122. Synthetic Drug Substance 合成原料药 . 12a. Flow chart of the synthesis 合成的流程图. 12b. Description of the synthesis 合成过程的描述. 13c. Purification of t
7、he drug substance 原料药的精制 . 14d. Changes in the synthesis 合成过程的变更 . 153. Reference Standard 对照品. 174. In Situ Products (not isolated) 原位产品（没有分离） . 175. Microencapsulation微型包囊法. 176. Antibiotics and Other Drug Substances from Fermentation or Natural Sources 由发酵或天然来源生成的抗生素和其他原料药. 18 a. Fermentation 发酵.
8、 18(1) Control procedures for starting materials/起始物料的控制程序. 18(2) Microbial identification, source, deposition微生物的鉴别、来源和沉积. 19(3) Fermentation process monitoring and control发酵工艺的监督和控制. 19b. Extraction, isolation, analysis, characterization 萃取、隔离、分析和鉴定. 20c. Drug substances obtained from plants and a
9、nimals/从植物和动物中获得的原料药. 22(1) Plants 植物 . 22(2) Animals 动物. 23d. Semisynthetic antibiotics and other drug substances derived from fermentation and natural sources 由发酵和天然来源得到的半合成抗生素和其他原料药 . 23 E. Process Controls 工艺控制. 241. Intermediates and In-process Controls/中间体和过程控制. 24a. Pivotal intermediate(s) 枢轴中间体. 26b. Key intermediate(s) 关键中间体. 26c. Final intermediate最后中间体. 262. Reprocessing 返工 . 27F. Drug Substance Controls原料药的控制. 291. Sampling 取样. 292. Release Controls 放行控制.
