Process Model of the Pharmaceutical Integrated Management System

Abstract

Introduction: One of the innovative trends in the modern development of the pharmaceutical sector is the introduction of integrated management systems (IMS) at the enterprises for the production and distribution of medicines. The aim: to substantiate and develop a process model and approaches to the regulation and documentation, performance evaluation and improvement of the IMS within the pharmaceutical institution (PI) and hospital pharmaceutical service (HPS). Materials and methods: research materials used: international standards, regulations and guidelines of the Ministry of Health of Ukraine, scientific publications, information of PI and hospitals, placed on official websites and collected in the process of direct observation. Research methods are: systemic-review, generalization, observation, documentary, structural-logical and graphic modeling. Results: Based on the requirements of good practices and international standards in the field of management of quality, ecology, occupational health and safety, social responsibility, a typical process model of the IMS of PI and HPS (pharmaceutical integrated management system − PIMS) has been substantiated and developed. The content of each process of a typical PIMS model is described and structured. The expected results (outputs) of the PIMS processes are determined. The approaches to the regulation and documentation of the PIMS processes in the conditions of functioning of the four-level documented information system are substantiated. A matrix of responsibility and authority of the staff of PI and hospitals within the PIMS is developed. The structurally hierarchical model of the performance evaluation and improvement of the PIMS has been designed and described. Conclusions: The results are the basis for the establishing, regulating and documenting of the PIMS and the development of a system for its performance evaluation and continual improvement.

Identification of benefits from Integrated Management Systems (IMS) to achieve Sustainability: A Systematic Literature Review

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Modern Approaches to the Formation of Professional Competencies of Pharmacists on Issues of Medicines Quality Assurance

“…At present, much of the issues previously taught at these cycles are included in the Internship program, as well as the educational programs «Pharmacy» that are taught in IHE and provide for the study by students of 5th year course of new narrow normative and selective disciplines on medicines quality assurance («Standardization of Medicines», «Good Pharmacy Practices», «Assurance and Control of Medicines Quality», etc.). Given this, it becomes obvious the need for the development and implementation of the short-term TIC with elements of distance learning in the educational process, which would provide the formation of a high level of professional competence of pharmacy professionals, in particular on the implementation of effective quality systems in pharmacy institutions [4].…”