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1、加拿大药监局发布加拿大药监局发布 GMPGMP 检查观察项风险分类修订版检查观察项风险分类修订版 加拿大药监局发布 GMP 检查观察项风险分类修订版（Risk Classification of Good Manufacturing Practices (GMP) Observations GUI-0023）。替代 2003-06-01 版，颁发 2012 年9 月 11 日，生效 2012 年 9 月 11 日。 本指南共 16 页。包括内容有：目的、背景、范围、指南（观察项的风险评估、检查评估评级、附加指南）和附件 A 和附件 B。 附件 A 在下列方面分别列出了关键缺陷项、主要缺陷项和一
2、般缺陷项的大量举例。1.设施；2.设备；3.人员；4.卫生；5.原材料；6.生产控制；7.质量控制部门；8.原材料检验；9.成品检验；10.记录；11.样品；12.稳写性；13.无菌产品。 附件 B 是术语。 加拿大药监局加拿大药监局 GMPGMP 检查观察项风险分类（检查观察项风险分类（1 1） Premises C.02.004 生产厂房 Note: Certain Risk 2 observations may be upgraded to a Risk 1. They are indicated with an arrow () 注：标有箭头()的某些 2 类不足项可能会上升到 1 类
3、风险项。 Risk 1 (Critical) Observations 关键不足项 No air filtration system to eliminate airborne contaminants that are likely to be generated during fabrication or packaging. 没有空气过滤系统以消除生产或包装时可能产生的尘粒污染。 Generalized malfunctioning of the ventilation system(s) with evidence of widespread cross-contamination.
4、大范围的交叉污染事实是由通风系统故障引起。 Inadequate segregation of manufacturing or testing areas from other manufacturing areas for high risk products. 生产区域或检测区域没有与其它高风险产品区域有效隔开。 Risk 2 (Major) Observations 主要不足项 Malfunctioning of the ventilation system that could result in possible localized or occasional cross-cont
5、amination. 空调系统的故障可能导致局部或偶然的交叉污染。 Maintenance/periodic verification such as air filter replacement, monitoring of pressure differentials not performed. () 没有执行维护/周期确认，例如空气过滤器、压差监测（） Accessory supplies (steam, air, nitrogen, dust collection, etc.) not qualified. 配件耗材（蒸汽，空气，氮气，集尘，不合格等）没有对公用工程的辅助系统进行确认
6、（例如：蒸汽、空气、氮气、尘埃收集等）。 Heat, Ventilation, Air Conditioning (HVAC) and purified water system not qualified. () 没有对 HVAC 和纯化水系统进行确认。（） Temperature and humidity not controlled or monitored when necessary (for example, storage not in accordance with labelling requirements). 当需要时（例如根据标签规定的贮存条件）没有对温湿进行控制或检测
7、。（） Damages (holes, cracks or peeling paint) to walls/ceilings immediately adjacent or above manufacturing areas or equipment where the product is exposed. 在生产操作区或设备上方或临近区域有墙壁/天花板损害（洞，裂纹或油漆剥落），可导致污染暴露的产品。 Un-cleanable surfaces created by pipes, fixtures or ducts directly above products or manufactur
8、ing equipment. 在产品或生产设备上面的固定管道的表面没有清洁。 Surfaces finish (floors, walls and ceilings) that do not permit effective cleaning. 没有对表面（地板，墙壁和天花板）进行有效的清洁。 Unsealed porous finish in manufacturing areas with evidence of contamination (mildew, mould,powder from previous productions, etc.). () 产品暴露区域具有污染源（霉菌，以
9、前生产产品的粉末等）。（） Insufficient manufacturing space that could lead to mix-ups. () 生产操作空间不充足，可导致混淆。（） Physical and electronic quarantine accessible to unauthorized personnel/Physical quarantine area not well marked and/or not respected when used. () 进入物理和电子隔离区的人员未经授权/隔离区没有标识/或不尊重隔离区的使用。（） No separate are
10、a/Insufficient precautions to prevent contamination or cross-contamination during raw material sampling. 原材料取样没有单独的区域或原材料取样时没有充足的预防污染与交叉污染的措施。 Risk 3 (Other) Observations 风险 3（其他）不足项 Doors giving direct access to exterior from manufacturing and packaging areas used by personnel. 生产与包装区域的人员通道直接与外部相联。
11、 Un-screened/Un-trapped floor drains. 地漏没有屏蔽密封。 Outlets for liquids and gases not identified. 液体和气体管道没有标识。 Damages to surfaces not directly adjacent or above exposed products. 非暴露产品的上面或临近区域的表面损伤。 Non-production activities performed in production areas. 在生产区域执行非生产活动。 Inadequate rest, change, wash-up
12、and toilet facilities. 不适当的休息室，更衣室，洗手设施和厕所设施。 加拿大药监局加拿大药监局 GMPGMP 检查观察项风险分类（检查观察项风险分类（2 2） Equipment C.02.005 设备 Note: Certain Risk 2 observations may be upgraded to a Risk 1. They are indicated with an arrow () 注：标有箭头()的某些 2 类不足项可能会上升到 1 类风险项。 Risk 1 (Critical) Observations 风险 1：关键不足项 Equipment use
13、d for complex manufacturing operations of critical products not qualified and with evidence of malfunctioning or lack of appropriate monitoring. 用于关键产品生产使用的复杂操作设备没有进行设备确认、 该设备具有故障或没有进行适当的监测。 Risk 2 (Major) Observations 风险 2：主要不足项 Equipment does not operate within its specifications. () 设备不能在其技术规格内运行
14、。（） Equipment used during the critical steps of fabrication, packaging/labelling, and testing, including computerized systems, is not qualified. () 用于关键步骤的生产，包装/贴签和检验关键步骤的设备，包括计算机系统没有进行确认。（） Tanks for manufacturing of liquids and ointments not equipped with sanitary clamps. 液体和药膏生产需要的罐没有配备卫生夹具。 Stor
15、ed equipment not protected from contamination. () 存储设备不能预防污染。（） Inappropriate equipment for production: surfaces porous and non-cleanable/material sheds particles.() 生产设备不适当：表面有孔和没有清洁/物料外泄（） Evidence of contamination of products by foreign materials such as grease, oil, rust and particles from the e
16、quipment. () 证据表明产品被来自设备的外来物所污染，例如：油脂，油，生锈和脱粒。（） No covers for tanks, hoppers or similar manufacturing equipment. 罐、料斗等类似设备不加盖。 No inadequate precautions taken when equipment such as oven or autoclave contains more than one product (possibility of cross-contamination or mix-ups). () 设备（例如烘箱或高压灭菌设备）用于多种产品时，没有采取适当的预防措施防止可能产生的交叉污染或混乱。（） Equipment location does not prevent cross-contamination or possible mix-ups for operations per
