Health Products and Food Branch Inspectorate食品与健康类产品检查员Guide-0023指南-0023Risk Classification of GMP Observations,2003 editionGMP 检查发现的风险分级,2003 版Supersedes:June 1st, 2000 editionDate issued: April 4th , 2003Date of implementation: June 1st, 2003Ce document est aussi disponible en français.本文可提供法语版TABLE OF CONTENTS目录1.0PURPOSE 目的........................................................................................................................................32.0BACKGROUND 背景.............................................................................................................................33.0SCOPE 范围.............................................................................................................................................34.0DEFINITIONS 定义:...............................................................................................................................45.0GUIDE 指南正文.....................................................................................................................................65.1Assignment of the risk to an observation 针对缺陷界定风险.............................................................65.2Assignment of the inspection rating 检查评定.....................................................................................75.2.1Risk 1 observation:1 类风险缺陷.............................................................................................75.2.2Risk 2 observation:2 类风险缺陷.............................................................................................75.2.3Risk 3 observations:3 类风险缺陷...........................................................................................85.3Additional guidance 补充.......................................................................................................................8Appendix 1 附录 1...........................