Development of organizational and management technology to improve the efficiency of the pharmaceutical quality system of the registration certificate holder

Introduction. The pharmaceutical industry is characterized by a number of features related to risks and risk management, and is subject to strict government regulation at all stages of the life cycle of drugs: production processes, product quality assurance, introduction into civil circulation and market circulation. These conditions create additional risks of non-compliance with legislation and regulatory requirements. Pharmaceutical companies invest significant funds in research and development of new drugs, which, in turn, is associated with high financial risks for the developer and holder of the registration certificate of the drug.

Objective. Development of methodological approaches to optimize the functioning, improve the efficiency of the pharmaceutical quality system and financial stability of the registration certificate holder.

Material and methods. The study used SWOT analysis, sociological, structural-logical methods, regression analysis. The materials for the study were regulatory documents and the results of the analysis of the conducted sociological survey

Results. As part of the development of organizational and management technology, based on the results of the survey, forms of recommended documents, a matrix, and a set of measures were developed. Three forms of documents: “Risk Register”, “Risk Map” and “Risk Review Plan” are developed in full compliance with current regulatory documents and allow the pharmaceutical company to standardize the risk assessment process, making it more transparent and systematized. Documents provide an effective means of communicating risk information to stakeholders and are useful for highlighting the most critical risks. They are particularly relevant at the operational level, where there is often a need to monitor a large number of risks, risk management measures and risk treatments in real time. In order to improve risk management processes and enhance product quality, a Risk Rating Factor (RRF) matrix was developed during the study. The RRF matrix is designed to assess the criticality of factors during reagent storage in the laboratory and is a tool for quantitatively assessing the risks associated with reagent storage conditions. Eight criteria have been developed for the assessment in this matrix. As a result of the assessment, a risk level is assigned on a scale: low, moderate and high risk. The proposed assessment criteria cover critical aspects affecting the stability and suitability of reagents during their preparation and storage in a pharmaceutical laboratory.

Conclusion. An organizational and managerial technology is proposed that represents a multifactorial approach to standardizing risk management methods based on the application of objective criteria for assessing quality risks and appropriate documented information.