德国药厂HOSPIRA因缺乏供应商确认导致召回

Lack of Supplier Qualification leads to Recall

缺乏供应商确认导致召回

The company Hospira Deutschland GmbH had to recall vials of their antibiotic drug Meropenem. The main reason for this was that a supplier of an important raw material was not qualified. As a result, this manufacturer was not listed in the respective authorisation and the batches affected did not correspond with the authorisation documents. According to a [url=]press release issued by Hospira GmbH[/url] (German text), the medical evaluation stated that "the risk of adverse events occurring as a result of this are to be considered low. There is currently no indication that patient safety was affected by the quality or efficacy."

HOSPIRA德国公司不得不召回其抗生素药美罗培南注射剂，主要原因是一个重要的原料供应商没有经过确认，因而该生产商没有列在相应的批准证书上，所以受影响的批次不符合批准的文件。根据HOSPIRA德国公司发布的消息（德文），医学评估声称”由此引起的不良反应风险被认为较低。现在没有证据显示患者安全受到质量或有效性的影响”。

Nevertheless, this example shows the negative and unpleasant consequences for companies and patients if suppliers are not or are inadequately qualified. A change notification for the supplier to be included in the authorisation documentation is currently in progress.

无论如何，本案例显示如果供应商没有经过确认或确认不充分，公司面临负面或不好的结果。官方正准备发布变更通知要求将供应商包括在批准文件里。

来源：Julia博客。免责声明：编辑对上述内容，对文中陈述、观点判断保持中立，不对所包含内容的准确性、可靠性或完整性提供任何明示或暗示的保证。仅作参考，并请各位自行承担全部责任。