DIRECTIONOFGMP(GOODMANUFACTURINGPRACTICE)OFRAWMATERIALSBYFDA美国FDA原料药生产质量管理规范(中英文)TableofContents目录1.INTRODUCTION 简介1.1Objective目的1.2RegulatoryApplicability法规的适用性1.3Scope范围2.QUALITYMANAGEMENT.质量管理2.1Principles总则2.2ResponsibilitiesoftheQualityUnit(s)质量部门的责任2.3Responsibilityfor...
DIRECTIONOFGMP(GOODMANUFACTURINGPRACTICE)OF RAWMATERIALSBYFDA 美国FDA原料药生产质量管理规范(中英文) TableofContents目录 1。INTRODUCTION简介 1。1Objective目的 1。2RegulatoryApplicability法规的适用性 1.3Scope范围 2。QUALITYMANAGEMENT。质量管理 2.1Principles总则 2。2ResponsibilitiesoftheQualityUnit(s)质量部门的责...
The contents of this document do not have the force and effect of law and are not meant to bind the public in any way, unless specifically incorporated into a contract. This document is intended only to provide clarit...
美国联邦法规汇编(Code of Federal Regulations,简称CFR)的入口: https://www.ecfr.gov/ 美国联邦法规汇编(Code of Federal Regulations,CFR)的第21篇“食品与药品”(Title 21―Food and Drugs)是供食品药品管理局(FDA)所使用的规定。 https://www.ecfr.gov/current/title-21 美国联邦法规(Code of FederalRegul...
· table of contents; · executive summary of the testing and results included in the module; · device deion and principles of operation; and · bibliography (with references only to articles relevant to that module). Duplication of some information between modules is necessary to allow the revi...
美国FDA验证高级培训Denis Kluba 博士吴培栋 博士1目录Table Of Contents验证定义CGMP对验证旳要求验证历史与期望验证综述验证主方案与规划实施验证旳措施验证旳技术内容要求执行验证方案工作流程变化控制再验证总结
TABLE OFCONTENTS ⽬录 I. INTRODUCTION 介绍 II. STATUTORY AND REGULATORY FRAMEWORK 法律法规框架 III. CLINICAL RISK OF VISIBLE PARTICULATES 可见颗粒物的临床风险 IV. QUALITY RISK ASSESSMENT 质量风险评估 V. VISUAL INSPECTION PROGRAM CONSIDERATIONS ⽬视检查的程序考虑 A. 100% Inspection 100%...
DIRECTIONOFGMP(GOODMANUFACTURINGPRACTICE)OFRAW MATERIALS BY FDA TableofContents 目录 1.INTRODUCTION 1.1 Objective 目的 1.2RegulatoryApplicability法规的适用性 1.3 Scope 范围 2.QUALITYMANAGEMENT .质量管理 2.1 Principles 总则 2.2 Responsibilities oftheQuality Unit(s) 质量部门的责任 ...
精选文档 DIRECTION OF GMP (GOOD MANUFACTURING PRACTICE )OF RAW MATERIALS BY FDA Table of Contents 目录 INTRODUCTION 1.1 Objective 目的 1.2 Regulatory Applicability 法规的适用性 1.3 Scope 范围 2. QUALITY MANAGEMENT 质.量管理 2.1 Principles 总则 2.2 Responsibilities of the Quality Unit(s) 质量部门的...
Identificationof predicate device 鉴定作为依据的医疗器械 Intention of510(k) 510(k)的目的 2 Table of Contents paginated and totalled 目录,包括页码与总计页数 3 510(k) ElementsList (optional) 510(k)要素表(可选) 4 Statement of Indications for Use ...