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1、企业风险管理加拿大 GMP 检 查风险分级 企业风险管理加拿大 GMP 检 查风险分级 Health Products and Food Branch Inspectorate 食品与健康类产品检查员食品与健康类产品检查员 Guide-0023 指南指南-0023 Risk Classification of GMP Observations, 2003 edition GMP检查发现的风险分级，检查发现的风险分级， 2003版版 Supersedes: June 1st, 2000 edition Date issued: April 4th , 2003 Date of implement
2、ation: June 1st, 2003 Ce document est aussi disponible en franais. 本文可提供法语版 TABLE OF CONTENTS 目录目录 1.0PURPOSE 目的.3 2.0BACKGROUND 背景.3 3.0SCOPE 范围.3 4.0DEFINITIONS 定义: .4 5.0GUIDE 指南正文.6 5.1Assignment of the risk to an observation 针对缺陷界定风险.6 5.2Assignment of the inspection rating 检查评定 .7 5.2.1Risk 1
3、observation:1 类风险缺陷.7 5.2.2Risk 2 observation:2 类风险缺陷.7 5.2.3Risk 3 observations:3 类风险缺陷.8 5.3Additional guidance补充.8 Appendix 1 附录 1.9 Appendix 2 附录 2.12 Appendix 3 附录 3.21 1.0 PURPOSE 目的目的 To classify the observations noted during establishment inspections according to their risk. 依据风险的程度对企业检查中的发现
4、进行分级。 To ensure uniformity among the inspectors of the Health Products and Food Branch Inspectorate (the Inspectorate) in the attribution of the rating following establishment inspections. 确保食品与健康产品检查员（检查员）在对企业进行评估时采用统一的标准。 To inform the industry of the situations that the Inspectorate considers una
5、cceptable and that will generate a Non Compliant (NC) rating following an inspection. 将各种不被检察员接受进而导致认证失败的情况明确告知企业。 2.0 BACKGROUND 背景背景 During an establishment inspection, deviations from the Food and Drug Regulations and the current edition of the Good Manufacturing Practices (GMP) guidelines are no
6、ted by the inspector and these deviations appear as observations in the inspection exit notice. A judgement based on these observations is then made by the inspector and an overall recommendation for the continuation or issuance of the establishment licence (rating of Compliance) or not to continue
7、or issue the licence (rating of Non- Compliance) is given. Attribution of a NC rating may have serious consequences for a company, ranging from the implementation of important corrective measures to the temporary suspension or termination of the Establishment Licence (EL). Therefore, these situation
8、s of non- conformity have to be well defined, unambiguous and directly supported by the applicable regulations. 在工厂检查时，凡违反食品药品法和现行GMP的行为都将被检察员记录下来作为离开时检查通告 中的检查缺陷。 基于这些缺陷，检查人员将做出判断并对是否应该授予或延续企业许可证（合规 评定）或不授予或取消企业许可证（不合规评定）给出综合性意见。得到不合规评定有可能给企 业带来严重的后果，包括停业整顿或吊销执照。因此，所有不合规的界定应有清晰明确的定义并 有章可循。 3.0 SCOP
9、E 范围范围 The definition of a drug in Canada covers a wide variety of products ranging from pharmaceuticals and biologics to natural health products such as homeopathics and herbal preparations. This guidance document covers all such products to which Division 2 of Part C of the Food and Drug Regulatio
10、ns applies and is based on the current edition of the GMP Guidelines. It is recognised that the evaluation of the conformity to the GMP should be commensurate with the risk involved taking into account the nature and extent of the deviation in relation with the category of products evaluated. Noneth
11、eless, most of the situations involving fraud, misrepresentation or falsification of products or data will generate a NC rating, irrespective of the category of products involved. 在加拿大，药品定义广泛，从生化药物到自然的健康产品如顺势疗法和草药都属于此范畴。本文 依照现行GMP制定，适用于所有食品药品法C部第2章节所规定的产品。GMP合规评估和风险评 估是同时进行的，而风险评估需要根据缺陷的性质与程度同时与评估产品的类别联系起来，这些 都已得到业界的认同。但是，大多数导致认证失败的发现如产品或数据存在虚假，歪曲或蓄意
