Methodical Approaches to Assessing the Performance of the Integrated System of Pharmaceutical Enterprise Management

• Main Authors: Svitlychna Karyna S., Shut Oksana Yu., Kovalenko Polina V.
• Format: Article
• Language: English
• Published: Research Centre of Industrial Problems of Development of NAS of Ukraine 2019-12-01
• Series: Bìznes Inform
• Subjects: integrated management system; pharmaceutical enterprise; medicines; international standards; quality assurance and safety system of manufactured medicines; quality management system; system of social responsibility
• Online Access: https://www.business-inform.net/export_pdf/business-inform-2019-12_0-pages-396_402.pdf
• ISSN: 2222-4459; 2311-116X

The article defines that one of the promising directions of ensuring the successful functioning of enterprise in the financial, production and social environment is the introduction of the integrated management systems that combine in themselves two or three or more international standards. It is defined that in the context of implementation of the integrated management system there are issues about evaluation of the level of performance of the system’s operation. The complexity of this issue is due to the multidimensionality and multi-levelity of such an evaluation. It is proved that for a pharmaceutical enterprise, the evaluation of the performance of the entire integrated management system should be based on the evaluation of all constituent systems, i.e.: systems to ensure the quality and safety of manufactured medicines (GMP industry rules), quality management systems (international standard ISO 9001:2015) and social responsibility systems (international standard ISO 26000:2010). On this basis, a generalized evaluation system consisting of seven stages is proposed. In the initial stages, the criteria and indicators for their evaluation are defined according to each management system. The formulas for calculating the level of performance of each management system and the overall level of performance of the entire integrated management system are provided. To ensure a qualitative interpretation of the resulting values, a scale has been proposed that reflects the level of stability of the entire integrated management system.