数据完整性缺陷的风险分级
原创 2018-03-19 翻译组 GMP办公室
近日，加拿大药监局发布《Risk classification guide for drug good manufacturing practices observations（GMP缺陷风险分级指南）》，其中将各类检查缺陷分为严重缺陷（风险级别1）、主要缺陷（风险级别2）、其他缺陷（风险级别3）三级，点击文章底部“阅读原文”或加入GMP办公室翻译组QQ群：307361958下载该文章，本文整理了关于记录方面的缺陷分级，供大家参考：
Critical observation (Risk 1) – Describes a situation that is likely to result in a product that may result in an immediate or latent health risk, or that involves fraud, misrepresentation or falsification of processes, products or data.
严重缺陷（风险级别1）-可能导致产品立即或潜在的健康风险，或表明工艺、产品或数据存在欺骗，有意隐瞒或弄虚作假。
Major observation (Risk 2) – Describes a situation that may result in the production of a drug not consistently meeting its marketing authorization. Some Risk 2 observations may be upgraded to Risk 1, for example in cases where the issue identified is not isolated to one area or system —these are indicated with an arrow (↑).
主要缺陷（风险级别2）-可能导致产品不能一贯的符合其上市许可。一些风险级别2的缺陷项可能升级为风险级别1，例如当所发现的问题不仅限于一个区域或系统——这些缺陷用(↑)标出。
Other observation (Risk 3) – Describes a situation that is neither critical nor major, but is a departure from the GMPs. Any Risk 3 observation could be upgraded to Risk 2.
其他缺陷（风险级别3）：指违反GMP但不是严重缺陷也不是主要缺陷。任何风险级别3的缺陷都可能升级为风险级别2.
Risk 1 (critical) observations
风险级别1（严重）缺陷
• Evidence showed that records had been falsified or misrepresented or inappropriately destroyed.
证据表明记录被篡改或有意隐瞒或不适当的毁坏。
Risk 2 (major) observations
风险级别2（主要）缺陷
• Records, results, or raw data used to support release were deleted or destroyed. (↑)
删除或销毁用于支持放行的记录、结果，或原始记录
• Test results suggesting that product quality had been negatively affected were not documented, reported or investigated. (↑)
未记录、报告和调查表明产品质量受到不良影响的检验结果
• Activities were not documented at the time they were performed. (↑)
未在活动进行时同步记录
• Electronic records were not maintained as raw data, where appropriate. (↑)
适当时，电子记录没有作为原始记录保存。
• Discrepancies were noted between electronically saved data and printed records. (↑)
电子保存的数据和打印版的记录之间存在差异
• There were no master production documents or these documents were incomplete.
没有主生产记录或这些记录不完整
• Suppliers did not provide documentation in a timely manner.
供应商未能及时提供文件记录
• Records of sale were incomplete or missing.
销售记录不完整或丢失
• Records of complaints received about the quality of a drug were incomplete or missing.
药品质量投诉相关的记录不完整或丢失
• Activities were not attributable to the person who performed them.
活动无法追溯到执行人
• Records that were required to be maintained were not kept in a readable and readily accessible format for an adequate period of time.
要求保存的记录没有以一种可读和易访问的形式保存足够时间
• Records were not named and organized in a manner that allowed for adequate traceability.
记录未命名和整理以使其有足够的可追溯性
• Management failed to prevent or deter poor data management practices.
管理未能预防和阻止数据管理的不良做法
• There was no requirement for an electronic data review and/or this review was inadequate.
未要求电子数据审核和/或审核不充分
• Not all information from the original label and/or fabricator’s certificate of analysis was made available to maintain the traceability of an active pharmaceutical ingredient.
无法获得原标签和/或厂家COA的所有信息来维护API的可追溯性
• Records of validation and/or periodic requalification were missing or incomplete.
验证和/或周期性确认记录丢失或不完整
Risk 3 (other) observations
风险级别3（其他）缺陷
• Plans and specifications for manufacturing buildings were incomplete.
厂房的示意图和规范不完整
• Records did not include the company’s organization charts.
记录未包括公司的组织架构图
• There were incomplete records for the sanitation program.
清洁消毒程序没有完整的记录
• There were no written procedures for how to archive and retrieve electronic data.
没有书面规程规定如何归档和复原数据