This section applies to the quality management review and assessment to ensure suitability, adequacy and effectiveness of the QMS. 本节适用于质量管理的审查和评估,以确保质量管理体系适宜性,充分性和有效性。
Develop and fulfill quality management system for internal review, external review. 负责制订质量管理体系内审、外审、管理评审计划并组织实施;
Senior management should be responsible for pharmaceutical quality system governance through management review to ensure its continuing suitability and effectiveness. 高级经理通过管理回顾负责药品质量体系的管理以确认持续的适应性和有效性。
To report on the performance of the quality system to the management for review and as a basis for improvement of the quality system. 将质量系统之运作情况向管理阶层提出报告,以供检讨,并作为改进质量系统的依据。
Reporting on the performance of the quality system to management with executive responsibility for review. 报告对业绩的质量体系管理与执行职能,以供审查。