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？
Is it acceptable to perform a remote assessment based on, for example,questionnaires, review of documents, Internation Organization forStandardization 9000 certification, results of analytical testing andhistorical experience with the supplier?
1 回答
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.
