加拿大药监局GMP检查观察项风险分类


blueski推荐 [2014-1-15]
出处:来自网上
作者:李永康
 

Premises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. 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-contamination. 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(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。(↑)

•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 manufacturing 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 area/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。

•Un-screened/Un-trapped floor drains. 地漏没有屏蔽密封。

•Outlets for liquids and gases not identified. 液体和气体出口没有确认。

•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 and toilet facilities. 不适当的休息室,更衣室,洗手设施和厕所设施。