外用药物制剂生产企业实施GMP的发展策略探析

随着现代社会和经济的快速发展,外用药物制剂市场竞争的焦点已经由原来的价格和数量逐渐被品牌和质量取代了。众多药品生产企业将产品的质量管理提升到一个新的高度。全面提升现代外用药物制剂生产企业的生产质量管理水平,对于提高生产操作人员的药品生产质量管理规范(GMP)意识,发挥着重要的指导作用。2010年版GMP对制药设备改造、洁净区人员配备及技术文件制定等方面进行指导,为GMP的高标准实施提供了保障。选择外用药物制剂为研究对象,通过大量的数据调研和文献收集,着重以最常见的乳膏制剂为例,针对当前外用药物制剂市场需求,运用现代化的产品质量管理模式,通过科学、系统化方法提高外用药物制剂的生产和质量管理规范,以减少因为产品质量问题而造成的损失,增强企业自身的竞争力,更好地应对市场的竞争。

Development Strategy Analysis of GMP Implementation for Manufacturing Enterprises of Topical Pharmaceutical Preparations

With rapid development of economy, market competition of topical pharmaceutical preparation is becoming increasingly fierce, the focus of market competition of price and quantity has been gradually replaced by brand and product quality, many pharmaceutical production enterprises have gradually improved their product quality management to a new level, which becomes strategic direction of enterprise development.With regard to all-round improvement of production quality management level of modern production enterprise of topical pharmaceutical preparation, it is significant to a great extent that production enterprise improves awareness of GMP of their production operation staffs.The 2010 edition of good manufacturing practices(GMP) covers analysis both in terms of software and hardware, such as production areas and equipments modification, staffing and technical documentation, in order to improve the overall management so that high level GMP implementation of pharmaceutical production can be ensured.Taking topical preparation as research object, through a lot of data research and literature collection, focused on the creams as an example, in view of current market demand of pharmaceutical preparation for external use, it should apply modern product quality management model with scientific methods to all-round improve production and quality of topical pharmaceutical preparation and to cut losses caused by product quality problem, so that enterprises could enhance their competitiveness and to better cope with market competition.