1 一般强制执行规章 GENERAL ENFORCEMENT REGULATIONS 2 一般行政规则与决定 GENERAL ADMINISTRATIVE RULINGS AND DECISIONS 3 产品管辖权 PRODUCT JURISDICTION 5 组织ORGANIZATION 7 强制执行政策 ENFORCEMENT POLICY 10 行政规范与程序 ADMINISTRATIVE PRACTICES AND PROCEDURES 11 电子化记录;电子化签名 ELECTRONIC RECORDS; ...
CGMP refers to the Current Good Manufacturing Practice regulations enforced by the FDA. CGMPs provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities. Adherence to the CGMP regulations assures the identity, strength, quality, and purity of drug ...
CGMP refers to the Current Good Manufacturing Practice regulations enforced by theFDA. CGMPs provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities. Adherence to the CGMP regulations assures the identity, ...
行业指南草案 本指南文件仅用于征求意见。 在《联邦公报》公布指导意见草案的日期之前,就本指导意见草案提交一套电子或书面意见。将电子评论提交至http://www.regulations.gov。将书面意见提交至Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852。
chapter and written procedures required by these regulations) as they relate to the employee's functions. Training in current good manufacturing practice shall be conducted by qualified individuals on a continuing basis and with sufficient frequency to assure that employees remain familiar with CGMP ...
procedures required by these regulations) as they relate to the employee's functions. Training in current good manufacturing practice shall be conducted by qualified individuals on a continuing basis and with sufficient frequency to assure that employees remain familiar with CGMP requirements applicable ...
什么是CGMP? what are CGMPs? CGMP refers to the Current Good Manufacturing Practice regulations enforced by the FDA. CGMPs provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities. Adherence to the CGMP regulations assures the identity, strength,...
近日,FDA 发布了《行业指南:非青霉素β-内酰胺类药物:预防交叉污染的CGMP框架》草案,概述了防止非青霉素 β-内酰胺类药物和化合物交叉污染的方法、设计和控制框架。 指南指出,制造商应采取与其他药物完全和全面分离的β-内酰胺类化合物...
1. federal food, drug, and cosmetic act (fd&c act):这是fda重要的法规之一,规定了对食品、药品、医疗器械和化妆品等产品的监管要求。fd&c法案确立了fda的权力和责任,包括产品的安全性、质量、标签要求、市场准入等方面的规定。 2. code of federal regulations (cfr):cfr是美国联邦法规的集合,其中包括了fda的...
103 such drugs if detectable levels of penicillin are found.9 104 105 Although FDA has not issued CGMP regulations specific to APIs, section 501(a)(2)(B) of the 106 Federal Food, Drug, and Cosmetic Act requires all drugs (including APIs) to be manufactured in 107 compliance with CGMP. ...