qcu

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。

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）。

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。

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。

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。

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。

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。