FDA行业指南预防非青霉素β内酰胺药物交叉污染CGMP框架正式版中英文双语.pdf

Guidance for Industry Non-Penicillin Beta-Lactam Drugs: A cGMP Framework for Preventing Cross-Contamination 行业指南：预防非青霉素β- 内酰胺类药物交叉 污染的cGMP框架 U.S. Department of Health and Human Services 美国卫生与公共服务部 Food and Drug Administration 美国食品与药品监督管理局 Center for Drug Evaluation and Research (CDER) 药品评价和研究中心（CDER ） April 2013 2013.04 Current Good Manufacturing Practices (CGMPs) 现行质量管理规范（CGMPs ） 1 Guidance for Industry Non-Penicillin Beta-Lactam Drugs: A cGMP Framework for Preventing Cross-Contamination 行业指南：预防非青霉素β- 内酰胺类药物交叉 污染的cGMP框架 Additional copies are available from: Office of Communications Division of Drug Information, WO51, Room 2201 Center for Drug Evaluation and Research Food and Drug Administration 10903 New Hampshire Ave. Silver Spring, MD 20993-0002 Phone: 301-796-3400; Fax: 301-847-8714 druginfo@ /Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) April 2013 Current Good Manufacturing Practices (CGMP) 2 TABLE OF CONTENTS 目录 I. INTRODUCTION简介 4 II. BACKGROUND背景6 III. RECOMMENDATIONS建议13 3 1 Guidance for Industry Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-Contamination 行业指南：预防非青霉素β- 内酰胺类药物交叉污染的CGMP框架 This guidance represents the Food and Drug Administrations (FDAs) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. Yo