产品的放行需要一个批记录以及先前被审核放行的质量控制部门的文件。
Release of products entails a Batch Record and Quality Control documentation reviewed prior to release.
成品批记录的审核应当包括环境监测的结果。
Results from monitoring should be reviewed as a part of batch documentation for finished product release.
生产过程中所用的取样方法，必须不影响洁净区的保护，当审核最终产品放行的批记录时，也要考虑环境监控的结果。
Sampling methods used in operation should not interfere with zone protection. Results from monitoring should be considered when reviewing batch documentation for finished product release.
仓储审计过程中将挑选几批已放行产品批次，对相应批记录文件进行审核。
Select product batches that have been released for supply during stores audit and arrange for finished batch documentation review.
在产品放行前，质量受权人必须按照上述第2项的要求出具产品放行审核记录，并纳入批记录。
Prior to the release of each batch, the Qualified Person must issue a review record for product release according to the requirements in the above paragraph 2, and archive it to the batch record.
确保批生产记录和批包装记录经过指定人员审核并送交质量管理部门；
To ensurethat the batch records of processing and packaging are evaluated and signed bya designated person before they are sent to the quality management department;
确保批生产记录和批包装记录经过指定人员审核并送交质量管理部门；
To ensurethat the batch records of processing and packaging are evaluated and signed bya designated person before they are sent to the quality management department;
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