Impact of quality audit on pharmaceutical companies’ performance: An exploratory study among practitioners

Abstract

In a highly regulated sector such as the pharmaceutical industry, where rigor and compliance with standards determine commercial viability and patient safety, quality auditing constitutes an essential mechanism for control and continuous improvement. However, practitioners' perceptions concerning its actual impact on organizational performance remain insufficiently studied.

This exploratory qualitative study aims to examine professionals' perceptions of the multidimensional impact of quality auditing within pharmaceutical companies. Based on qualitative methodology, it relies on semi-structured interviews conducted with seven quality managers, enabling the capture of the understanding of their experiences and perspectives. The collected data were analysed using NVivo software, facilitating the identification of recurring themes and significant patterns.

The results reveal a positive correlation between the implementation of quality audit recommendations and overall performance improvement. Nevertheless, this relationship is not automatic and encounters substantial obstacles such as the inherent complexity of pharmaceutical processes, cultural resistance to change and audit methodological failures. The study also identifies several critical moderating factors, namely senior management's commitment to creating a sustainable quality culture as well as the technical and interpersonal skills of auditors, which directly influence the acceptability of findings and the relevance of recommendations.

In conclusion, if the identified challenges are addressed and the conditions for effective implementation are met, quality auditing could undeniably establishes itself as a true value creation vector and a sustainable competitive advantage for pharmaceutical companies.

Keywords : quality audit, organizational performance, pharmaceutical industry, challenges, moderating factors.

Classification JEL : D22, L25, L65, M42

Paper type : Empirical Research