加拿大GMP检查风险分级.docVIP

第 PAGE 5 页 共 NUMPAGES 25 页 Health Products and Food Branch Inspectorate 食品与健康类产品检查员 Guide-0023 指南-0023 Risk Classification of GMP Observations, 2003 edition GMP检查发现的风险分级， 2003版 Supersedes: June 1st, 2000 edition Date issued: April 4th , 2003 Date of implementation: June 1st, 2003 Ce document est aussi disponible en fran?ais. 本文可提供法语版 TABLE OF CONTENTS目录 TOC 1.0 PURPOSE目的 3 2.0 BACKGROUND背景 3 3.0 SCOPE范围 3 4.0 DEFINITIONS定义: 4 5.0 GUIDE指南正文 6 5.1 Assignment of the risk to an observation针对缺陷界定风险 6 5.2 Assignment of the inspection rating检查评定 7 5.2.1 Risk 1 observation:1类风险缺陷 7 5.2.