【正文】 ufacturing processes involved are plex. 非處方低劑量藥物如維生素，微量元素類制劑以及4類產(chǎn)品（）盡管制造工藝非常復(fù)雜但仍不被認(rèn)作為最高風(fēng)險(xiǎn)產(chǎn)品。S narrow therapeutic window具有窄治療窗的藥物S high toxicity劇毒性藥物S sterile product無(wú)菌產(chǎn)品S biological drug生物藥品S plex manufacturing process:生產(chǎn)工藝復(fù)雜的產(chǎn)品Process for which slight deviations in the control of parameters could result in a nonuniform product or a product not meeting its specifications. As example, powder mixing or granulation for low dosage solid forms, long acting / delayed action products, sterile products. 工藝參數(shù)控制上一點(diǎn)小的偏差便能引發(fā)產(chǎn)品不均一或不合格的情況。）附錄3列舉了可以上升為2類風(fēng)險(xiǎn)的3類風(fēng)險(xiǎn)。Other observation一般缺陷:Observation that is neither critical nor major but is a departure from the GMP.一般缺陷指不屬于嚴(yán)重或主要缺陷但偏離GMP要求的缺陷。 Appendix 2 lists observations that are considered major and which will be assigned a Risk 2 CertainRisk 2 observations may be upgraded to Risk 1. They are indicated with an arrow (↑ ). 附錄2列出了檢察員認(rèn)為屬于2類風(fēng)險(xiǎn)的主要缺陷。Appendix I lists observations that the Inspectorate considers critical which will be assigned a Risk 1.附錄1列出了檢察員認(rèn)為屬于1類風(fēng)險(xiǎn)的嚴(yán)重缺陷。缺陷分為嚴(yán)重，主要和一般，分別用1（代表嚴(yán)重），2（代表主要），3（代表一般）表示其風(fēng)險(xiǎn)級(jí)別。The numbering system assigned to each section in the appendices is a reference to the applicable regulations in the current edition of the GMP guidelines.附件各章節(jié)中的數(shù)字代表現(xiàn)行GMP法規(guī)中相關(guān)章節(jié)，以備參考。The appendices attached to the present document describe the observations related to each category of risk. Please note that the list of observations in each appendix is not exhaustive and that additional observations may be added where appropriate.本文附錄描述了檢查發(fā)現(xiàn)相應(yīng)的風(fēng)險(xiǎn)級(jí)別。GMP合規(guī)評(píng)估和風(fēng)險(xiǎn)評(píng)估是同時(shí)進(jìn)行的，而風(fēng)險(xiǎn)評(píng)估需要根據(jù)缺陷的性質(zhì)與程度同時(shí)與評(píng)估產(chǎn)品的類別聯(lián)系起來(lái)，這些都已得到業(yè)界的認(rèn)同。 SCOPE范圍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 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 mensurate 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 category of products involved. 在加拿大，藥品定義廣泛，從生化藥物到自然的健康產(chǎn)品如順勢(shì)療法和草藥都屬于此范疇。得到不合規(guī)評(píng)定有可能給企業(yè)帶來(lái)嚴(yán)重的后果，包括停業(yè)整頓或吊銷執(zhí)照。 BACKGROUND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 noted 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 remendation for the continuation or issuance of the establishment licence (rating of Compliance) or not to continue or issue the licence (rating of NonCompliance) is given. Attribution of a NC rating may have serious consequences for a pany, ranging from the 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. 在工廠檢查時(shí)，凡違反食品藥品法和現(xiàn)行GMP的行為都將被檢察員記錄下來(lái)作為離開(kāi)時(shí)檢查通告中的檢查缺陷。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.確保食品與健康產(chǎn)品檢查員（檢查員）在對(duì)企業(yè)進(jìn)行評(píng)估時(shí)采用統(tǒng)一的標(biāo)準(zhǔn)。Health Products and Food Branch Inspectorate食品與健康類產(chǎn)品檢查員Guide0023指南0023Risk Classification of GMP Observations,2003 editionGMP檢查發(fā)現(xiàn)的風(fēng)險(xiǎn)分級(jí)，2003版Supersedes:June 1st, 2000 editionDate issued: April 4th , 2003Date of implementation: June 1st, 2003Ce document est aussi disponible en fran231。ais.本文可提供法語(yǔ)版23 / 23TABLE OF CONTENTS目錄 PURPOSE目的 3 BACKGROUND背景 3 SCOPE范圍 3 DEFINITIONS定義: 4 GUIDE指南正文 6 Assignment of the risk to an observation針對(duì)缺陷界定風(fēng)險(xiǎn) 6 Assignment of the inspection rating檢查評(píng)定 7 Risk 1 observation:1類風(fēng)險(xiǎn)缺陷 7 Risk 2 observation:2類風(fēng)險(xiǎn)缺陷 7 Risk 3 observations:3類風(fēng)險(xiǎn)缺陷 8 Additional guidance補(bǔ)充 8Appendix 1附錄1 9Appendix 2 附錄2 12Appendix 3附錄3 21 PURPOSE目的To classify the observations noted during establishment inspections according to their risk.依據(jù)風(fēng)險(xiǎn)的程度對(duì)企業(yè)檢查中的發(fā)現(xiàn)進(jìn)行分級(jí)。To inform the industry of the situations that the Inspectorate considers unacceptable and that will generate a Non Compliant (NC) rating following an inspection.將各種不被檢察員接受進(jìn)而導(dǎo)致認(rèn)證失敗的情況明確告知企業(yè)。 基于這些缺陷，檢查人員將做出判斷并對(duì)是否應(yīng)該授予或延續(xù)企業(yè)許可證（合規(guī)評(píng)定）或不授予或取消企業(yè)許可證（不合規(guī)評(píng)定）給出綜合性意見(jiàn)。因此，所有不合規(guī)的界定應(yīng)有清晰明確的定義并有章可循。本文依照現(xiàn)行GMP制定，適用于所有食品藥品法C部第2章節(jié)所規(guī)定的產(chǎn)品。但是，大多數(shù)導(dǎo)致認(rèn)證失敗的發(fā)現(xiàn)如產(chǎn)品或數(shù)據(jù)存在虛假，歪曲或蓄意偽造都沒(méi)有考慮產(chǎn)品的類別。請(qǐng)注意附錄中并未完全列舉所有的檢查發(fā)現(xiàn)，需要之處可以補(bǔ)充。 DEFINITIONS定義:The following definitions are provided to plement those already available under the glossary of terms in the current edition of the GMP Guidelines or other related documents referenced in the GMP Guidelines.以下定義是對(duì)現(xiàn)行GMP法規(guī)或其相關(guān)文件釋義部分的補(bǔ)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 pany in the exit notice. The observations are classified as “Critical”, “Major” and “Other” and are assigned a risk classification, ranging from 1 for “critical” to 2 for “major” to 3 for “other”. 藥品企業(yè)檢查過(guò)程中，所有被檢查人員寫入報(bào)告的偏差或不足。Critical observation 嚴(yán)重缺陷:Observation describing a situation that is likely to result in a nonpliant 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. 嚴(yán)重缺陷包括可能導(dǎo)致產(chǎn)品不合格的缺陷，可能對(duì)健康造成立即的或延后的危害的缺陷以及涉及產(chǎn)品或數(shù)據(jù)存在虛假，歪曲或蓄意偽造的缺陷。