非青霉素类β内酰胺药物风险评估cGMP框架指南.docx

Guidance for Industry 行业指南 Non-Penicillin Beta-Lactam Risk Assessment: A CGMP Framework 非青霉素β-内酰胺类抗生素风险评价： CGMP 框架 DRAFT GUIDANCE 指南草案 This guidance document is being distributed for comment purposes only. 本指南文件仅用于征求社会意见用 Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register. 关于本指南的评论和建议请在本指南登于联邦公报后60日内提交至美国食品药品管理局卷宗管理处 （HFA-305），地址：马里兰州罗克维尔市菲舍斯巷630号1061室，邮编：20852。所有评论都以登于联邦公 报上的可用声明卷宗号作为识别标记。 For questions regarding this draft document contact (CDER) Edwin Melendez 301-796-3284. 如对本指南有疑问，请联系药品评价和研究中心（CDER）Edwin Melendez，电话301-796-3284。 U.S. Department of Health and Human Services 美国卫生与公众服务部 Food and Drug Administration 美国食品药品管理局 Center for Drug Evaluation and Research (CDER) 药品评价和研究中心(CDER) March 2011 2011年3月 Current Good Manufacturing Practices (CGMPs) 现行药品生产质量管理规范(CGMPs) Guidance for Industry 行业指南 Non-Penicillin Beta-Lactam Risk Assessment: A CGMP Framework 非青霉素β-内酰胺类抗生素风险评价： CGMP 框架 Additional copies are available from: 如需副本，请联系： Office of Communications 对外信息办公室 Division of Drug Information, WO51, Room 2201 药品信息处，WO51大厦，2201室 Center for Drug Evaluation and Research 药品评价和研究中心 Food and Drug Administration 美国食品药品管理局 10903 New Hampshire Ave. 新罕布什尔大道10193号 Silver Spring, MD 20993-0002， 马里兰州银泉市，邮编：20993-0002 Phone: 301-796-3400; Fax: 301-847-8714 电话: 301-796-3400; 传真: 301 -847-8714 druginfo@ /Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm U.S. Department of Health and Human Services 美国卫生与公众服务部 Food and Drug Administration 美国食品药品管理局 Center for Drug Evaluation and Research (CDER) 药品评价和研究中心(CDER) March 2011 2011年3月 Current Good Manufacturin