SDA规定所有医药经营企业在2004年年底前必须通过GSP认证,未通过者将被淘汰“出局”。因此,力争通过认证是目前医药经营企业的一项重要任务,而申请认证的准备工作,要求对“硬件”进行一系列的投入、改造的同时,还要按GSP实施细则、规定和要求建立、健全“软件”。 “软件”是指企业申请认证所需的各种文件,如规章制度、图表,各种原始记录、 SDA stipulates that all pharmaceutical companies must pass the GSP certification by the end of 2004 and those who fail to be eliminated will be eliminated. Therefore, trying to pass the certification is an important task for the pharmaceutical enterprises at present, and the preparatory work for applying for the certification requires that a series of inputs and alterations be made to the “hardware”, and at the same time, it should be established according to GSP implementation rules, regulations and requirements, Improve the “software.” “Software” refers to the various documents required by enterprises to apply for certification, such as rules and regulations, charts, all kinds of original records,