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资料准备是企业实施GSP达标验收的一项具体工作。如何准备?原则应依据国药质(1997)第163号,国药质(1998)第170号文件提出的基本要求,做好初审、推荐和验收阶段中资料申报工作。除了填报统一的表格以外,专就企业的资料准备简要介绍如下: 1 资料的结构层次 GSP达标验收资料,企业准备有三个层次。第一层次是企业实施GSP达标的总体汇报材料,主要
Data preparation is a specific task for an enterprise to implement GSP compliance acceptance. How to prepare? The principle should be based on the basic requirements set out in the National Pharmaceutical Quality (1997) No. 163, National Pharmaceutical Quality (1998) No. 170 document, and do a good job in the data declaration in the stages of preliminary examination, recommendation and acceptance. In addition to filing a unified form, the information preparation for enterprises is briefly described as follows: 1 Structure of the data hierarchy The GSP meets the acceptance data and the company prepares to have three levels. The first level is the overall reporting material for companies implementing GSP compliance, mainly