Developing professional competencies in pharmaceutical distribution auditing

Abstract

Background:

Pharmaceutical distribution auditing is a critical mechanism for safeguarding medicines supply chains in line with Good Distribution Practice (GDP), identifying operational risks, and supporting corrective and preventive measures that contribute to continued improvement. Regulatory authorities form an important part of this ecosystem, working alongside stakeholders and industry to ultimately serve patients. In this context, the Malta Medicines Authority (MMA) undertakes initiatives aimed at strengthening professional competence, which is essential to ensuring robust oversight as pharmaceutical distribution networks continue to evolve. Accordingly, this initiative sought to strengthen pharmaceutical distribution auditing by building on academic training and providing an applied perspective, equipping professionals with the knowledge, skills, and competencies required to support the integrity and performance of medicines supply chains.

Method:

The MMA Academy for Patient Centred Excellence and Innovation in Regulatory Sciences, licensed as a Further and Higher Education Institution, developed a programme leading to an Award in Pharmaceutical Distribution Auditing, accredited by the Malta Further and Higher Education Authority as Level 6 on the Malta/European Qualifications Framework. The course was delivered in October 2025 and comprised 50 learning hours (2 ECTS), including 22 hours of face-to-face content led by subject-matter experts. Topics addressed include auditing principles, GDP requirements, risk-based planning, documentation and data integrity, corrective and preventive action plans, regulatory inspection preparedness, quality systems and management of outsourced activities. Programme effectiveness was evaluated through a post-course electronic evaluation tool consisting of a 5-point Likert scale. Data collected was analysed to evaluate participants’ feedback.

Results:

Nineteen local and international participants, practicing in private or public sectors, successfully completed the programme (N=19). Evaluation responses (n=16) demonstrated consistently positive feedback across all aspects assessed. Most respondents (70%) assigned the highest overall rating to the course, whilst all participants agreed that the course met their expectations and indicated that they would recommend it to colleagues. Feedback highlighted the quality and organisation of the course, the expertise and engagement of the speakers and the interactive learning environment as key strengths. The structured content and practical focus were perceived as particularly valuable in supporting the application of GDP principles in professional practice.

Conclusion:

Outcomes indicate that this educational intervention was highly valued by participants and effective in supporting the intended learning objectives related to pharmaceutical distribution auditing. By facilitating knowledge exchange and strengthening professional competencies in pharmaceutical distribution auditing, the programme contributes to capacity-building by translating participants’ academic learning into practical competencies. Continued development and expansion of such targeted initiatives shall further support preparedness in increasingly complex healthcare and regulatory environments.