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近年来我们在医院自制制剂生产实施GMP管理中体会到:房屋、设施等硬件是基础,记录为主体的各 种标准、规章制度、操作规程等软件是保障,而起决定性的关键因素是人的因素。英国药品生产管理规范的序言最后一段话强调了“人的因素第一”,指出“各级人员在药品质量保证中的重要性是无论怎样强调都不会过分的。所报道的药品质量方面的事故,绝大多数都是由人为过错所引起的,而不是工艺的原因。”因此重视发挥人员在医院制剂生产中的质量保证作用是搞好医院自制制剂生产,确保病人用药安全有效的头等大事。而GMP对人员在药品生产质量保证中的地位和要求十分明确,这主要体现在如下几个方面:
In recent years, we have realized in the implementation of GMP management for hospitalized self-preparation production: hardware such as houses and facilities is the foundation, and the records of various standards, rules and regulations, operating procedures and other software are the guarantees, and the decisive key factor is human. factor. The last paragraph of the preambular paragraph of the UK Code of Pharmaceutical Production Management emphasizes the “human factor first” and states that “the importance of personnel at all levels in drug quality assurance is not overemphasized. The reported drug quality aspects The vast majority of accidents are caused by human errors rather than technological reasons.” Therefore, the importance attached to the quality assurance role of staff in the production of hospital preparations is a top priority for hospitals to make their own preparations to ensure the safety and effectiveness of patient medications. . The position and requirements of GMP for personnel in drug production quality assurance are very clear, which is mainly reflected in the following aspects: