Sterilisation records should be available for each sterilisation run. They should be approved as part of the batch release procedure.
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。
Documents to be provided: organization diagram, job descriptions for QP, QA, QC and production managers, batch release procedure for finished products.
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。
The basic arrangements for batch release for a product are defined by its Marketing Authorisation. Nothing in this annex should be taken as overriding those arrangements.
成品放行在上市许可中有基本要求。本附件条款不能凌驾于上市许可之上。
应用推荐