质量是制药行业的生命线,而GMP是保证药品质量的法规,所有制药企业都应该遵从GMP的规定进行实施。我国GMP规范的基本要点是:各级管理人员和技术人员的配置;厂区、车间、公用工程等硬件设施;设备方面的硬件和管理软件系统;卫生、原、辅、包装材料、成品的质量要求及储存规范;生产管理系统;生产管理和质量管理文件系统;质量管理系统;包装材料和 Quality is the lifeline of the pharmaceutical industry, and GMP is a regulation that guarantees the quality of medicines. All pharmaceutical companies should comply with GMP regulations. The basic points of China’s GMP regulations are: the configuration of management personnel and technicians at all levels; hardware facilities such as factory areas, workshops, and public works; hardware and management software systems for equipment; quality requirements for sanitary, raw, auxiliary, packaging materials, and finished products And storage specifications; production management systems; production management and quality management documentation systems; quality management systems;