数字技术的使用目的是改进在药品生产企业中创建药品质量体系的方法方法

Q3 Pharmacology, Toxicology and Pharmaceutics
V. V. Goryachkin, V. A. Smirnov, V. N. Shestakov, R. Abramovich
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引用次数: 0

摘要

介绍。本文致力于改进在药品生产企业中创建药品质量体系(PQS)的方法方法,同时考虑到使用数字化工具和手段的可能性。这项研究的相关性与在药物开发、生产和进入流通的释放过程中全面高质量保证的持久重要性有关。PQS的实施需要管理和生产过程的大量转变,这可以通过数字化的工具和元素来促进。考虑数字技术的潜力和具体应用领域,以改进开发和实施PQS的方法和实践。材料和方法。该主题领域的状况是根据俄罗斯制药企业实施PQS的经济和统计分析和预测结果进行评估的,这些企业在该领域具有积极和相对较长的经验:OZON有限责任公司和AKRIKHIN JSC公司。通过计算PQS功能有效性的积分指标来进行评估,该指标是一组质量加权关键绩效指标(KPI)。结果和讨论。介绍了引入PQS对制药企业发展的重要性,以及在实施PQS中存在的许多困难,这需要改进该学科领域的方法方法。事实证明,即使在那些引入PQS并取得不同程度成功的企业中,使用数字化工具也有助于更快、更系统和高质量地实施PQS。在数字工具应用的关键领域中,作者提出了质量指标监测(使用神经网络卡)和使用区块链平台和智能合约来注册适当质量的药品的发布。数字工具有助于社会经济活动许多领域的复杂改善。它们在制药企业的积极使用是为了通过对制成品质量的持续监测和在高精度信息存储系统中对制成品批次的注册,有助于确保药品质量体系的正确实施和不间断运行。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
The Use of Digital Technologies for the Purpose of Improving Methodological Approaches to the Creation of a Pharmaceutical Quality System at Enterprises for the Production of Medicines
Introduction. The article is devoted to the aspects of improving methodological approaches to the creation of a pharmaceutical quality system (PQS) at enterprises for the production of medicines, taking into account the possibility of using tools and means of digitalization. The relevance of the study is associated with the enduring importance of comprehensive high quality assurance in the development, production and release of medicines into circulation. The implementation of PQS requires numerous transformations of management and production processes, which can be facilitated by tools and elements of digitalization.Aim. To consider the potential and specific areas of application of digital technologies to improve the methodology and practice of developing and implementing PQS.Materials and methods. The state in the subject area was assessed on the basis of the results of economic and statistical analysis and forecasting of the implementation of PQS at Russian pharmaceutical enterprises that have positive and comparatively long experience in this area: the companies LLC "OZON" and JSC "AKRIKHIN". The assessment was carried out by calculating the integral indicator of the effectiveness of the functioning of PQS, which is a set of weighted key performance indicators (KPI) for quality.Results and discussion. The importance of the introduction of PQS for the development of pharmaceutical enterprises and the presence of numerous difficulties in the implementation of PQS, which necessitates the improvement of methodological approaches in the subject area, are stated. It has been proven that even at those enterprises where PQS has been introduced with varying degrees of success, the use of digitalization tools would contribute to a faster, more systematic and high-quality implementation of PQS. Among the key areas of application of digital tools, the authors propose monitoring of quality indicators (using neural network cards) and the use of blockchain platforms and smart contracts to register the release of drugs of appropriate quality.Conclusion. Digital tools contribute to complex improvement in many areas of socio-economic activity. Their active use at pharmaceutical enterprises is intended to contribute to ensuring the proper implementation and uninterrupted functioning of pharmaceutical quality systems, through constant monitoring of the quality of manufactured products and registration of manufactured batches in high-precision information storage systems.
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来源期刊
Drug Development and Registration
Drug Development and Registration Pharmacology, Toxicology and Pharmaceutics-Pharmaceutical Science
CiteScore
1.20
自引率
0.00%
发文量
61
审稿时长
8 weeks
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