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采用远程评估方式,例如,基于对调查问卷、评估文件、ISO9000证书、分析检测结果和该供应商的历史经验进行评估是否可行?

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kk444555 一阶会员 用户来自于: 广东省深圳市
2023-10-17 23:09

EEA检查官一般不倾向于“纸面审计”,因为这样无法提供与现场评估相同水平的结果,但可以接受将其作为基于风险策略的一部分。

如果可以获得近期检查信息,且过去的现场审计都令人满意时,就可以采用这种方法。书面审计不能代替对原料药供应商进行的现场审计,但可以作为生产商审计计划的中间和临时措施。

The EEA inspectorates are not generally in favour of 'paper-based audits' per se as they do not provide the same level of assurance as on-site assessments, but doaccept that they have a part to play in a risk-based strategy.

They may be particularly applicable when recent positive inspection information isavailable and where satisfactory audits have been concluded in the past. Theycannot replace on-site audits of active-substance suppliers but can be a usefulinterim and temporary measure within the manufacturer's audit programme.


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发布时间
2023-10-17 23:08
更新时间
2023-10-17 23:09
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