现场是否有：组织机构图、岗位说明书（质量受权人、质量保证部经理、质量控制部经理和生产部经理）、成品批放行程序。
Documents to be provided: organization diagram, job descriptions for QP, QA, QC and production managers, batch release procedure for finished products.
每一次灭菌都要有灭菌记录，并作为批产品放行程序的一部分进行批准。
Sterilisation records should be available for each sterilisation run. They should be approved as part of the batch release procedure.
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.
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.
如果只有一批产品返工，可以写一份报告，一旦认为该批可接受，即可放行。
If there is only one batch to be reworked, then a report can be written and the batch released once it is found to be acceptable.
如果只有一批产品返工，可以写一份报告，一旦认为该批可接受，即可放行。
If there is only one batch to be reworked, then a report can be written and the batch released once it is found to be acceptable.
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