Research on Several Key Problems of the Drug Retail Enterprises Implementing GSP Electronic Supervision

L. Ye, Jingxiang Li, Hai Zeng, G.-X. Zhao
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Abstract

In May 2008, SFDA released the implementation scheme of drug electronic supervision work, bringing forward clear requirements for the informatization supervision work of drug safety. The condition of standardizing the enterprise operation process through implementing GSP management software aiming at the electronic supervision of the drug retail enterprises has been mature. This paper carries out deep research, practice exploration and detailed explanation aiming at the three key problems of the electronic supervision of drug retail enterprises: compulsory enforcement of GSP flow, safe storage of GSP information, stable upload of GSP data. The paper also makes expectation combining the development trend of drug supervision in China and aiming at the future development of the electronic supervision work of the drug retail enterprises.
药品零售企业实施GSP电子监管的几个关键问题研究
2008年5月,国家食品药品监督管理局发布了《药品电子监管工作实施方案》,对药品安全信息化监管工作提出了明确要求。针对药品零售企业的电子监管,通过实施GSP管理软件规范企业运营流程的条件已经成熟。本文针对药品零售企业电子监管的三个关键问题:GSP流程的强制执行、GSP信息的安全存储、GSP数据的稳定上传进行了深入的研究、实践探索和详细的说明。结合中国药品监管的发展趋势,针对药品零售企业电子监管工作的未来发展进行了展望。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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