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1、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 franais.本文可提供法语版TABLE
2、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8Ap
3、pendix 1附录19Appendix 2 附录212Appendix 3附录3211.0 PURPOSE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进行分级。To ensure uniformity among the inspectors of the Health Products and Food Branch Inspectorate (the Inspectorate) in the attribution
4、 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 unacceptable 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During an
5、establishment inspection, deviations from the Food and Drug Regulations and the current edition of the Good Manufacturing Practices (GMP) guidelines are noted by the inspector and these deviations appear as observations in the inspection exit notice. A judgement based on these observations is then m
6、ade by the inspector and an overall recommendation for the continuation or issuance of the establishment licence (rating of Compliance) or not to continue or issue the licence (rating of Non-Compliance) is given. Attribution of a NC rating may have serious consequences for a company, ranging from th
7、e implementation of important corrective measures to the temporary suspension or termination of the Establishment Licence (EL). Therefore, these situations 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
8、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 SCOPE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
9、homeopathics and herbal preparations. This guidance document covers all such products to which Division 2 of Part C of the Food and Drug Regulations 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 commensu
10、rate with the risk involved taking into account the nature and extent of the deviation in relation with the category of products evaluated. Nonetheless, most of the situations involving fraud, misrepresentation or falsification of products or data will generate a NC rating, irrespective of the categ
11、ory 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，歪曲或蓄意伪造都没有考虑产品的类别。The appendices attached to the present document describe the observations related to each ca
12、tegory of risk. Please note that the list of observations in each appendix is not exhaustive and that additional observations may be added where appropriate.本文附录描述了检查发现相应的风险级别。请注意附录中并未完全列举所有的检查发现，需要之处可以补充。The numbering system assigned to each section in the appendices is a reference to the applicabl
13、e regulations in the current edition of the GMP guidelines.附件各章节中的数字代表现行GMP法规中相关章节，以备参考。4.0 DEFINITIONS定义:The following definitions are provided to complement those already available under the glossary of terms in the current edition of the GMP Guidelines or other related documents referenced in the
14、 GMP Guidelines.以下定义是对现行GMP法规或其相关文件释义部分的补充Observation 缺陷:A deviation or deficiency to GMP noted by an inspector during the inspection of a drug establishment that is confirmed in writing to the company in the exit notice. The observations are classified as “Critical”, “Major” and “Other” and are ass
15、igned a risk classification, ranging from 1 for “critical” to 2 for “major” to 3 for “other”. 药品企业检查过程中，所有被检查人员写入报告的偏差或不足。缺陷分为严重，主要和一般，分别用1（代表严重），2（代表主要），3（代表一般）表示其风险级别。Critical observation 严重缺陷:Observation describing a situation that is likely to result in a non-compliant product or a situation that may result in an immediate or latent health risk and any observation that involves fraud, misrepresentation or falsification of products or data. 严重缺陷包括可能导致产品不合格的缺陷，可能对健康造成立即的或延后的危害的缺陷以及涉及产品或数据存在虚假，歪曲或蓄意伪造的缺陷。App
