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.
应用推荐