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数据完整性缺陷的风险分级
发布时间:2018/3/29 15:44:10

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 observationsGMP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