Quality Management in Pharmaceutical Development of Biotechnology-Derived Medicinal Products: Implementation and Evaluation

Abstract

SCIENTIFIC RELEVANCE. One of the challenges associated with the development of medicines lies in creating a quality management system (QMS) and tools to assess its performance.AIM. The study aimed to propose a QMS model for the development of biotechnology-derived medicinal products and a performance evaluation tool for this QMS universally applicable in the research centre of the company regardless of the specific activities of its individual divisions.MATERIALS AND METHODS. The study analysed internal audit outcomes, noncompliance responses, and the document flow of the research centre. Parameter values for quality index (QI) calculations were entered into validated Microsoft Excel spreadsheets. Data analysis and visualisation involved using the Microsoft Power Business Intelligence (BI) business analytics platform (mainly, the Power BI Desktop and Power BI Service components).RESULTS. The QMS was implemented, and the authors proposed their QMS performance evaluation tool universally applicable to all the divisions of the research centre. CONCLUSIONS. The authors proposed their QMS model for the development of biotechnology-derived medicinal products and the QI tool for collecting digital data, carrying out standardised monitoring, and tracking QMS status changes. The QI tool is universal for all company departments regardless of their requirements, easy to use, and customisable by adding individual company-specific quality parameters. This makes the QI tool applicable not only to drug development departments but also to other research units.

Keywords

• quality management system
• qms
• pharmaceutical development
• drug development
• biotechnology-derived medicinal products
• standard operating procedure
• sop
• internal audits
• inspections