qcu

The QCU failed to maintain authority and responsibility for conducting adequate investigations.

该QCU未能保持足够的权威和进行调查的责任。

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Failure to establish and follow adequate written procedures applicable to the quality control unit ( QCU).

未能建立足够的书面程序，并按照适用的质量控制单元（QCU）。

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After a thorough investigation, a firm's QCU might conclude that the initial OOS result did not reflect the true quality of the batch.

经过彻底调查后，公司的质量部门可能认为首次报告的OOS结果不能真实反映该批产品的质量。

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The QCU did not reject failing batches of drug product.

该QCU没有拒绝失败的药物产品批次。

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The QCU failed to review production records to assure that no errors have occurred, that they have been fully investigated, and conduct investigations.

该QCU没有审查生产记录，以确保没有错误时有发生，他们已经得到了充分的调查，并进行调查。

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The QCU is responsible for interpreting the results of the investigation.

质量部门应负责对调查的结果进行解释。

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Failure of the quality control unit ( QCU) to review and approve changes to established written procedures.

质量控制单元（QCU）未审查和批准，以建立书面程序的变化。

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