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.
应用推荐