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如果活性物质供应商已接受过EEA成员国的审计,且其GMP证书在有效期内,我是否还需要对其进行审计?

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kk444555 一阶会员 用户来自于: 广东省深圳市
2023-10-17 23:08

生产许可持有人有时会对其检查义务范围产生疑惑,但是不管怎样,如果供应商具有检查报告,或由EEA互认伙伴及其它互认国家药监局签发的GMP证书,均可以给生产许可持有人提供有用的信息。

然而,这并不能完全代替GMP指南第5.25部分提出的生产许可持有人的法定义务和要求,但生产许可持有人可以将上述检查结果与其它支持性信息结合,采用基于风险的方法建立其自己对活性物质生产商的审计程序。

Manufacturing-authorisation holders sometimes confuse the role of inspectorates with their own obligations but nevertheless, when inspection reports or GMP certificates issued by European Economic Area (EEA) mutual-recognition-agreement (MRA) partners or other recognised authorities are available, these can provide useful information to manufacturing-authorisation holders.

However, these alone cannot fulfil the statutory obligations of themanufacturing-authorisation holder or the requirements of section 5.29 of theGMP guideline , but the results of inspections may be used together with othersupporting information in a risk-based approach by the manufacturer inestablishing priorities for its own audit programme of active-substancesuppliers.


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2023-10-17 23:08
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2023-10-17 23:08
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