Organization of reviews of a pharmaceutical enterprise quality management system functioning

V. Lebedynets, O. Prokhorenko, M. Zarichkova
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Abstract

Aim. To determine the state of organizing the process of analyzing the quality management system of a typical pharmaceutical enterprise in accordance with the current industry requirements of Good Manufacturing Practice and the ISO 9001:2015 standard, as well as substantiating effective approaches to improving this activity. Materials and methods. We used analysis, comparison, questionnaires, surveys and direct observations. The results were processed and verified using licensed Microsoft Office Excel software products. Results. The relevance of the development of quality management systems (QMS) of domestic pharmaceutical organizations in the period of martial law has been proven. The requirements of the DSTU ISO 9001:2015 standard, as well as the requirements of the guidelines on Good Manufacturing Practice (GMP) of medicines for reviewing and analyzing QMS of pharmaceutical enterprises (PhE) have been analyzed. Approaches to the organization of QMS review at a number of domestic PhE have been studied; as a result, typical inconsistencies of these procedures have been determined. Based on the results of the study and the experience analyzed in supporting the QMS functioning of PhE, effective organizational approaches have been identified, and recommendations are given for the effective analysis of QMS of PhE. Conclusions. In the study conducted, a review of the practice of analyzing QMS at a number of domestic and foreign PhE has been carried out, and typical inconsistencies of this process have been identified and systematized. The requirements of the DSTU ISO 9001:2015 standard, as well as the industry requirements of the GMP guidelines for reviewing and analyzing the quality system of PhE have been analyzed. Based on the results of the research and the authors’ own experience in implementing and supporting the QMS functioning of PhE, the main organizational approaches and recommendations for analyzing QMS of PhE have been determined.
组织审查制药企业质量管理体系的运行情况
目的根据当前行业对《药品生产质量管理规范》和 ISO 9001:2015 标准的要求,确定典型制药企业质量管理体系分析过程的组织状况,并证实改进这一活动的有效方法。材料和方法。我们采用了分析、比较、问卷、调查和直接观察等方法。我们使用获得许可的 Microsoft Office Excel 软件产品对结果进行了处理和验证。结果戒严时期国内制药机构质量管理体系(QMS)发展的相关性已得到证实。分析了 DSTU ISO 9001:2015 标准的要求,以及药品生产质量管理规范 (GMP) 指南对审查和分析制药企业 (PhE) 质量管理体系的要求。对一些国内制药企业组织质量管理体系审查的方法进行了研究,从而确定了这些程序中典型的不一致之处。根据研究结果和在支持制药企业质量管理体系运作方面的经验分析,确定了有效的组织方法,并为有效分析制药企业质量管理体系提出了建议。结论。在研究中,对国内外一些工厂和设备的质量管理体系分析实践进行了回顾,发现了这 一过程中典型的不一致之处,并将其系统化。分析了 DSTU ISO 9001:2015 标准的要求,以及 GMP 指南对审查和分析 PhE 质量体系的行业要求。根据研究结果和作者自身在实施和支持 PhE 质量管理体系运行方面的经验,确定了分析 PhE 质量管理体系的主要组织方法和建议。
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