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？
Do I need to perform an audit of an active substance supplier if it has been inspected by an inspectorate from a European Economic Area (EEA) Member State and a valid GMPcertificate is available?
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.
