全球质量经理的培训教材..ppt

Objectives 培训目的 Introduction to GMP’s? 良好生产操作规范（GMP’s) 概述 Why do we need GMP’s 我们为什么需要GMP’s？ When to we use GMP’s? 我们何时需要用到GMP’s？ General Overview of basic cGMP Requirements CGMP基本要求总揽 Key differences from the QMS 与质量管理体系的关键区别 Implementing for success 成功的方法 Introduction to GMP’s 良好生产操作规范引言 GMP’s defined History Applications GMP‘s 定义 历史 适用范围 cGMP’s Overview最新食品及药物生产质量管理规范概要 North Asia Quality Managers Meeting March 6, 2007 Taipei Taiwan 北亚质量经理会议 2007，3，6，台北，台湾 Current Good Manufacturing Practices (cGMP) 最新食品及药物生产质量管理规范 Good Manufacturing Practices are…. the current minimum guidelines for controlling the manufacturing, processing, packing and holding of drug products to assure that the products are safe for use, are properly identified, of proper strength, and of appropriate quantity and quality. 生产管理规范是指。。。 现行是指用以控制生产，进程，包装和保持药品的最小方针，以此确保产品固有的数量及质量，并安全的被使用。 GMP History GMP历史 Food and Drug Administration - Federal Food, Drug and Cosmetic Act of 1938, as Amended: 1938年美国联邦政府食品药物管理规范规定： To protect the consumers from unsafe or deceptively labeled or packaged products by prohibiting the movement in interstate commerce of adulterated or misbranded food, drug, devices and cosmetics.通过禁止次级或被错误标记的食品，药品，设备和化妆品国际贸易中的变动，以确保消费者的利益不被危险性的或者带有欺骗性的标签和包装的产品所侵害。 Food and Drug Administration 食品，药品规程 The U.S. Food and Drug Administration (FDA) is a public health agency that is charged with protecting American consumers by enforcing the U.S. Federal Food, Drug, and Cosmetic Act and other related public health laws. 美国食品药物管理局是通过实施美国联邦政府食品药物管制及其他相关公众健康法规，以确保美国消费者健康的公众机构。 Food and Drug Administration 食品和药物管制 Basic FDA Product Requirements Safe for intended use Drugs and devices effective for intended use Not adulterated (i.e., contains what, and only what, it is supposed to contain) Not misbranded (i.e., labeled as it should be) Manufactured in compliance with applicable cGMPs 美国联邦政府食品药物管制基本要求 产品用途安全性 药品及设备有效使用 未渗入次品（如产品包含成分，仅有成分等） 无错误标记（如标签） 按照可行的最新食品及药品生产质量规范进行生产 Wh