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目前国家食品药品监督管理局正在筹划对我国医疗器械与药品统一实施GMP管理。从ISO 13485到GMP,体现了在管理上更加强调了医疗器械的专业性、提高了法规的指导性和操作性。这同时又给制药企业一个信息,GMP是动态的、发展的一门科学,GMP在其发展的过程中不断吸收质量管理新的理论和实践精华,在GMP不断发展的今天,除了它一直强调的产品实现的过程外,已经越来越关注过程和体系的方法、关注与供方的关系、关注改进。ISO9000族标准对八项质量管理原则和质量管理体系的要求进行了系统的总结,并上升到理论体系的高度,企业如何认识它并应用它,将其原则和要求灵活运用到GMP中,充实企业质量管理体系的基础,巩固GMP成果,并不断的创新和发展是一个亟待思考的问题。本刊特椎荐上海佰加壹医药有限公司探索企业质量管理体系的经验,旨在给同行在GMP动态管理中有所启示。
At present, the State Food and Drug Administration is planning to implement GMP management on medical devices and medicines in China. From ISO 13485 to GMP, it reflects the more emphasis on the management of professional medical equipment, improve the guidance and operability of laws and regulations. This at the same time gives a message to pharmaceutical companies. GMP is a dynamic and developing science. GMP constantly absorbs the essence of new theory and practice of quality management during its development. In the continuous development of GMP, apart from what it always emphasizes The process of product realization, more and more attention has been paid to the process and system approach, focusing on the relationship with the supplier, focusing on improvement. ISO9000 standard system of eight quality management principles and quality management system requirements were systematically summarized and rose to the height of the theoretical system, how to understand it and apply it to enterprises, their principles and requirements of the flexible use of GMP, enrich the business The basis of a quality management system, the consolidation of GMP results, and continuous innovation and development are issues that we must ponder. This publication is especially recommended Shanghai Bai Canadian Medicine Co., Ltd. to explore the enterprise quality management system experience, designed to give colleagues in the GMP dynamic management has some implications.