药品经营企业GSP内审工作探讨

GSP Interior Appraisal in Drug Managing Enterprises

目的探讨药品经营企业如何有效开展《药品经营质量管理规范》(GSP)内审工作。方法从分析开展GSP内审工作的总体要求、存在的问题入手,明确内审工作的主要操作程序和纠正方法,保证内审工作落到实处,达到预期目的。结果与结论 GSP内审是药品经营企业质量管理体系持续改进的重要手段,是对药品经营企业质量管理体系运行情况是否达到规定要求的有效评估,是规范企业经营行为,保障群众用药安全、有效、及时的重要工作,只要GSP内审工作到位,方法得当,即可起到应有效果。

Objective To discuss how to effectively carry out GSP interior appraisal in drug managing enterprises. Methods From the general requirements and problems analysis of the GSP interior appraisal,the main operating procedures were cleared and the methods of interior appraisal were corrected,the implementation of interior appraisal was ensured,and the intended purpose was achieved. Results and Conclusion GSP interior appraisal is an important means that can continuously improve quality management system of drug managing enterprises,effectively evaluate whether the quality management system operation achieve the prescribed requirements,it is an important work for standardizing enterprise management and ensuring the drug use being safe,effective and timely. As long as the work is in place and in the right way,this work can play its effect.