Studying Strategies for Implementing Quality Culture in Pharmaceutical Organizations

Abstract

Quality culture implementation in pharmaceutical firm increasingly face challenges to ensuring that patients are provided with medications that are safe, effective and produced at a high level of quality. Despite recent advances in the manufacturing sector quality issues remain frequent occurrence and can result in recalls, withdrawals or harm to patients. A number of strategies have been utilized in various pharmaceutical firms to ensure quality culture for high quality drug products. However, a synthesis of the literature on these strategies has not previously been undertaken. Methods: We reviewed articles published in following websites that assessed and studied interventions for implementing quality culture in pharmaceutical companies and other i.e. non-pharmaceuticals companies. We organized the intervention in each study into three groups: Interventions aiming to increase involvement and empower of employees. Interventions aiming to transform management philosophy on quality culture i.e. Doing right and not what is easy in business. Combined employee and management interventions. We summarized the main quantitative outcomes from each study and effective practices from each intervention category. Results: Ten studies were identified; one described interventions designed to improve employee’s perspective and engagement towards quality culture, one described interventions that aimed to increase management involvement day-to-day quality culture and eight studies aiming to improve both availability of employees and management participation and engagement in quality culture roll-out and implementation. All studies reported positive change. Conclusions: Few studies have assessed interventions designed explicitly for the unique challenges facing quality culture roll-out in pharmaceutical firms. Further research on sustainability, scalability and cost effectiveness of interventions is needed to fill this gap