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今年全国医药企业质量工作的主要任务之一是突出推行GMP和ISO 9000系列标准。GMP与ISO 9000系列标准如何接轨呢? 一、什么是GMP GMP是药品制造过程的质量规范,是进行药品生产和质量管理的基本准则。自第一个GMP出现以来,在保证药品的生产质量和加强企业管理等方面效果蜚然。在世界卫生组织倡导下,世界各国都相继推行GMP。按照GMP要求生产药品,已成为药品进入国际
One of the major tasks of the quality work of pharmaceutical companies throughout the country this year is to highlight the implementation of the GMP and ISO 9000 series of standards. How does the GMP and ISO 9000 series of standards converge? First, what is GMP? GMP is the quality specification of the pharmaceutical manufacturing process and is the basic principle for pharmaceutical production and quality management. Since the emergence of the first GMP, the effectiveness of ensuring the production quality of drugs and strengthening the management of enterprises has been in vain. Under the initiative of the World Health Organization, all countries in the world have implemented GMP in succession. Production of pharmaceuticals in accordance with GMP requirements has become an international entry for pharmaceuticals