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自从国家医药管理局颁发了“医药行业推行GMP,GSP计划八年规划纲要”以来,国内制药企业,药用辅料生产企业及药用包装材料生产企业纷纷行动起来,制订方案并积极贯彻落实,充分表明了对GMP实施的重视。相信在不久的将来,一定会有为数众多的企业达到GMP的各项要求。同时,应当看到,有不少企业感到实施GMP千头万绪,茫然不知所措;有些企业不知把有限的人物财力投放到什么地方;有的耽心在实施GMP时走弯路;针对这些问题,笔者提出以下几点意见,供有关企业及医药管理部门在实施“纲要”时参考。
Since the National Pharmaceutical Administration issued the “Plan for the implementation of GMP and GSP plans for eight years in the pharmaceutical industry,” domestic pharmaceutical companies, pharmaceutical excipient manufacturers, and pharmaceutical packaging material manufacturers have taken actions to formulate plans and actively implement them. It fully shows the importance of GMP implementation. It is believed that in the near future, there will be a large number of companies that meet the requirements of GMP. At the same time, it should be noted that many companies feel that the implementation of GMP is in vain and they are overwhelmed. Some companies do not know where to put the limited financial resources; some are taking the wrong direction when implementing GMP; The author proposes the following points for reference by relevant companies and the pharmaceutical administrative department when implementing the “Outline”.