2017/8/10 合规政策指南 CPG章节345.100 避孕套; 缺陷 - 直接扣押的标准 /ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/ucm073902.htm PAGE 2/5 CPG章节345.100避孕套;缺陷 - 直接扣押的标准背景:长久以来,FDA一般对于含有缺陷的避孕套产品进行扣押。1968年6月4日,FDA发布了避孕套抽样和检查计划,为行政...
The Food and Drug Administration (FDA) Compliance Policy Guides (CPGs) manual provides a convenient and organized system for statements of FDA compliance policy, including those statements which that contain regulatory action guidance information. The CPG Manual is the repository for all agency ...
ComplianceProgram Guidance Manual (CPGM) 合规项目指南手册 FDACompliance Policy Guides (CPG) 合规政策指导 FDARegulatory Procedures Manual (RPM) 监管程序手册 IOM:Investigations Operations Manual 调查活动手册 FieldManagement Directives 场地管理指令 InspectionGuides 检查指导 InspectionTechnical Guides 检查技术指导...
ObjectivesofInspection检查的目标 •ConducttheinspectioninaccordancewithFD&CActandCurrentGoodManufacturingPractice(CGMP)Regulations检查的执行依据《联邦食品，药品和化妆品法》(FD&CAct)及现行药品生产管理规范(CGMP)条例 •Accomplishwhatisnecessarypertheestablished,supportingCompliancePolicyGuidanceManual检查执行的程度依据...
4.ProcessValidationRequirementsforDrugProductsandActivePharmaceuticalIngredientsSubjecttoPre-MarketApproval,CompliancePolicyGuide490.100(7132c.08),March12,[] (符合性方针指南相关上市同意前药品和药品活性组件工艺验证要求) 5.PerformanceofTestsforCompendialRequirementsonCompendialProducts,CompliancePolicyGuide420.400(7132.05)...
[1] FDA. CPG Sec. 400.400 Conditions Under Which Homeopathic Drugs May be Marketed[EB/OL]. https://www.fda.gov/iceci/compliancemanuals/compliancepolicyguidancemanual/ucm074360.htm,1988-05-31(2017-09-15) 转载此版本请保留出处,并注明转载自“国际药政通”(SYPHU-IFDPL)。
CPG:Compliance Policy Guide:执行政策指南 CPGM:Compliance Program Guidance Manual:执行项目指导手册 C/R(CR):Collection Report:取样报告 CTP:Center for Tobacco Products:烟草制品中心 CVM:Center for Veterinary Medicine:兽药中心 DCIA:Division of Small Manufacturers,Consumer & InternationalAffairs:小型企业、消费...
Compliance Policy Guide CPG 82Compliance Program Guidance Manual CPGM 83consumer price index CPI 84Committee for Proprietary Medicinal Products (EMEA) CPMP 85critical process parameter CPP 86Consumer Product Safety Commission CPSC 87Current Procedural Terminology (AMA) CPT 88clinical research associate CRA...
In addition,a listing of Compliance Policy Guides that deal with packaging issues is provided in Attachment B. References in this guidance to CGMP regulations are provided for completeness. For additional information,refer to theFDA Compliance Program Guidance Manualfor Pre-Approval Inspections/...
包括:Guidances (Drugs)药物指南、Report a Product Quality Issue报告产品质量问题、Resources For You Compliance Policy Guide, Chapter 4 - Human Drugs合规政策指南,第4章--人类药物、Manual of Policies & Procedures (CDER) 政策和程序手册(CDER)等。