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.
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.
在生产现场和库房审核该条款时,应记录审核到的产品名称、标识方法、标识内容等;以及采取了哪些可追溯性标识方法。
In situ production and warehouse audit this provision, shall record the audit to the product name, identification method, identification content; and what traceability identification method.
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.
按照物流计划,将包装后的产品提交承运商,并做好相应的记录,送交相关人员审核,签署。
Handing over the after-packing products to the carrier according to the logistics plan. Making relevant record, and deliver to relevant personnel for verifying and signing.
按照物流计划,将包装后的产品提交承运商,并做好相应的记录,送交相关人员审核,签署。
Handing over the after-packing products to the carrier according to the logistics plan. Making relevant record, and deliver to relevant personnel for verifying and signing.
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