医院制剂管理的文件系统

目的：为医院制剂达到ＧＭＰ要求提供参考建议。方法：分标准和记录两部分论述医院制剂管理文件系统。结果和结论：医院制剂室定应参照ＧＭＰ的要求，结合自己的特点和生产实际来制定“软件系统”。“软件系统”以人员、物料、设备、生产、质量等管理的文件系统为核心，是可以通过主观努力达到较高水准的。

File Systems of Pharmaceutic Management in Hospital

OBJECTIVE: To provide reference for meeting with GMP requirement in hospital preparations. METHODS: Thefile systems of pharmaceutics management in hospital have been discussed, which consists of following two parts: the standardsand the notes. RESULTS & CONCLUSION: "Software systems" of pharmaceutics management in hospital should be established refering to requirement of GMP, considering the characteristic of its own and the actual situation of production. The"software systems", whose nuclei are the file systems of management of personnel. material, equipment, production,quality andso on, can come up to more advanced level by means of subjective efforts.