Scientific Online Resource System

Varna Medical Forum

Impact of quality management system on company performance - attitudes of Bulgarian pharmaceutical industry employees

Reneta Stefanova


Introduction: Establishment of a Quality Management System (QMS) is a regulatory requirement in the pharmaceutical industry. However, besides the regulatory obligations of the manufacturers for QMS and for the adherence to the Good Manufacturing Practice (GMP) rules, the senior management must ensure sustainable business performance in the highly competitive environment of the industry. This necessitates seeking opportunities and approaches for adding value to the company performance from apparently “hidden” sources, e.g. QMS itself.

Aim: The purpose of this study is to investigate the attitudes of the different categories of personnel of a Bulgarian pharmaceutical manufacturer to QMS as a factor for company performance.

Materials and Methods: A structured interview was conducted with the employees of a large Bulgarian pharmaceutical company in the period July-September 2019. An anonymous questionnaire with 11 statements, which had to be accepted or rejected, was completed by 101 respondents from different structural units (production, quality control, etc.) and different levels in the company (from operators to managers).

Results: The majority of the respondents (68.3%) stated that the quality system definitely contributes to the company performance and development, and another 29.7% agreed with this statement with some reserves. According to the employees, the effectively operating QMS has a positive impact on the pharmaceutical company performance and development, mainly through the standard operating procedures (SOP), which facilitate the execution of the company activities and the quality risk management. The positive assessment by the employees of the role of rules and their impact on company performance indicates their maturity and awareness towards quality issues. A positive fact is that the employees from quality control and from production do not differ in their assessment of the contribution of SOP’s for the smooth operation of the company and the company results. Similarly, there is no difference between the attitudes of managers and department heads on one hand and the operators on the other. The importance of the training of the personnel in the quality issues and quality management is underestimated by the employees, especially by the operators.

Conclusion: The employees appreciate the significance and impact of the effectively operating QMS on the company performance. It is recommended that practical examples be used in personnel training focusing on risk management, internal audits and handling of deviations, and on the effect of those tools on the quality of the products and the development of the business.


quality management, quality management system, pharmaceutical manufacture, company performance

Full Text


EudraLex - Volume 4 Good manufacturing practice (GMP) Guidelines (Available at:;

Стефанова, Р., А. Димова, Система за управление на качеството и разходи за качество на българките фармацевтични производители, Здравна икономика и мениджмънт, бр. 4, ИК „Стено“ – Варна, 2018;

Стефанова, Р., А. Димова, Система за управление на качеството като фактор на конкурентоспособността на българските производители, Здравна икономика и мениджмънт, бр. 1, ИК „Стено“ – Варна, 2019;

Директива 2003/94/ЕО на Европейската Комисия,;

Наредба №15 от 17 април 2009г.,;

EudraLex - Volume 4 Good manufacturing practice (GMP) Guidelines (Available at:;

Директива 2001/83/ЕО на Европейския парламент и на Съвета от 6 ноември 2001 г. за утвърждаване на Кодекс на Общността относно лекарствени продукти за хуманна употреба, (достъпна на:;

Закон за лекарствените продукти в хуманната медицина (достъпен на:;

International Conferences on Harmonization/ICH (2008), Guidance for Industry, Q10: Pharmaceutical Quality Systems, Current Step 4 version dated 4 June 2008 (Available at:


Font Size