Quality Management System and Cost of Quality of the Bulgarian Pharmaceutical Manufacturers

Introduction: The pharmaceutical industry is one of the sectors where high quality is vital because it is directly related to patient safety. It operates in a highly regulated environment that imposes a number of specific requirements affecting the price of medicines and, hence, their availability. Strong competition in the industry requires the use of management approaches with synergy in terms of quality and price. This study examines the impact of the quality management system on the cost of quality of pharmaceutical manufacturers in Bulgaria. Materials and Methods: Different types of pharmaceuticals` quality costs has been analysed. The Bulgarian pharmaceutical manufacturers` attitudes about the impact of the quality management system on quality costs were studied, using a semi-structured questionnaire designed for the purpose of the study. Results: According to the interviewed senior managers, the most significant costs of quality (structured in four categories: costs for prevention, evaluation, internal and external problems solving) are those for prevention and evaluation. This is due to the fact that there are many regulatory requirements for both products and production processes. All respondents confirm that the pharmaceutical quality management system (PQMS) can significantly influence the competitiveness factors related to the price and quality of the products but fewer are those who believe that even being an effective, a PQMS can reduce costs and increase profitability significantly. The differences in senior managers` attitudes towards PQMS and its impact on the company`s economic growth and competitiveness factors are most likely related to the different levels of PQMS effectiveness reached by the pharmaceutical manufacturers. Conclusion: According to the Bulgarian pharmaceutical manufacturers, the quality management system has high potential to improve economic performance of the company by reducing costs. For this purpose, investments in both preventive activities and PQMS effectiveness are of crucial importance.