Results from monitoring should be reviewed as a part of batch documentation for finished product release.
成品批记录的审核应当包括环境监测的结果。
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.
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。
One alternative is for a Q. P. of the manufacturing authorisation holder making the bulk production batch to certify all the finished product batches before release to the market.
使用同一各生产许可证,将半成品批次在不同的厂址形成不同的成品批次。
应用推荐