药品生产技术成熟度评价方法研究与探讨

Research and Discussion on Evaluation Method of Drug Production Technology Maturity

目前,我国缺少在药品生产技术成熟度的理论研究和应用模型。本文基于技术成熟度理论和实际应用发展,参考国外生物医学技术成熟度评价模型,根据我国药品生产行业实际情况,梳理药品生产技术成熟度指标,运用模糊综合评判法确定各个指标的权重,基于深度神经网络的机器学习方法的评价模型,最终制定出一套完整的评价模型,包含评价技术模型算法、配套标准和技术性文件和相应的评价管理流程。评价模型致力于药品生产企业自我精准评价,并且为监管部门提供一定参考。

At present, there is a lack of theoretical research and application model of drug production technology maturity in China. Based on the theory of technical maturity and the practical application and development, this paper refers to the evaluation model of foreign biomedical technical maturity applied in drug production, according to the actual situation of drug manufacturing industry in China, cards the indicators of pharmaceutical production technical maturity,uses the fuzzy comprehensive evaluation method to determine the weight of each indicator, and finally works out a complete set of evaluation model based on the evaluation model of machine learning method of in-depth neural network,which includes evaluation technology model algorithm, supporting standards and technical documents, and corresponding evaluation management process. The evaluation model is dedicated to the self-accurate evaluation of drug manufacturers,and provides a certain reference for regulatory departments.