Keywords
Good Distribution Practices
ISO 9001:2015
compliance assessment
wholesale pharmaceutical establishments
Democratic Republic of the Congo
How to Cite
Abstract
Introduction
Two major trends have been observed in the Democratic Republic of the Congo (DRC) over the past decades: the increasing number of licences issued to open wholesale pharmaceutical establishments and the circulation of medicines of questionable quality. These trends raise serious concerns about population health.
Purpose
The aim of this study was to assess compliance with Good Distribution Practices (GDP) and ISO 9001:2015 standards among wholesale pharmaceutical establishments (WPEs) operating in the Democratic Republic of the Congo.
Methods
This cross-sectional study was conducted from January to June 2025 in the city of Kinshasa. Twenty-five pharmaceutical depots were randomly selected from a total of 110 wholesale pharmaceutical establishments listed by ACOREP in Kinshasa Province. Data were collected using two assessment tools (one for GDP and the other for ISO 9001:2015), direct observation of infrastructure, and semi-structured interviews with managers. The collected data were analysed using the chi-squared test to assess homogeneity and heterogeneity between establishments.
Results
Statistical analysis revealed significant heterogeneity among the studied establishments. Of the 25 pharmaceutical warehouses assessed, the reported p-values varied according to the evaluated standards and parameters. Regarding GDP, only one parameter demonstrated homogeneity, namely the documentation system (p = 0.622). All other parameters showed significant heterogeneity: quality system (p = 0.0239), personnel (p = 0.001), medicine storage (p < 0.001), and information technology systems (p = 0.0295). For ISO 9001:2015, homogeneity was observed for leadership (p = 1), planning (p = 0.854), and performance evaluation (p = 0.638). However, heterogeneity was identified in organisational context (p < 0.001), support (p < 0.001), operational activities (p < 0.001), and continuous improvement (p = 0.0716).
Conclusion
Compliance with GDP and ISO 9001:2015 standards remains insufficient in the Democratic Republic of the Congo, particularly with regard to ensuring the quality and safety of medicines. Continuous auditing and inspection of wholesale pharmaceutical establishments are required nationwide, especially in Kinshasa, where more than 70% of such establishments are located. Continuing professional education on GDP and ISO standards for pharmacists and their staff must be strengthened according to a structured schedule. The role of the responsible pharmacist should also be reinforced, and warehouse owners must make substantial contributions to quality assurance efforts. The observed operational heterogeneity among wholesale pharmaceutical establishments compromises medicine quality assurance in Kinshasa. Urgent action by health authorities is required to safeguard the health security of the Congolese population.
References
Abubakar, A. R., Sim, B. L. H., & Kumar, R. (2020). Compliance with good distribution practices in pharmaceutical supply chains in Nigeria. Journal of Pharmaceutical Policy and Practice, 13(1), 1–10. https://doi.org/10.1186/s40545-020-00254-6
African Development Bank. (2020). Quality of supply chains in Africa: Challenges and opportunities. African Development Bank Group.
African Union. (2022). Report on governance and quality in African healthcare facilities. African Union.
Kaboré, M., Ouedraogo, A., & Sawadogo, R. (2019). Implementation challenges of quality management systems in West African pharmaceutical supply chains. Journal of Global Health, 9(2), 020410.
Khurelbat, D., Dorj, G., Sunderland, B., Sanjjav, T., Bayarsaikhan, E., Damdinjav, D., Jigjidsuren, A., Lkhagvasuren, O., & Erdenetsetseg, B. (2020). A cross-sectional analysis of falsified, counterfeit and substandard medicines in a low- and middle-income country. BMC Public Health, 20(1), 743. https://doi.org/10.1186/s12889-020-08897-x
Kouame, K., Mensah, E., & Agbodjan, P. (2021). Leadership and quality management practices in African pharmaceutical institutions. African Journal of Management, 7(3), 45–59.
Mbanya, W., Nkoum, B., & Essomba, R. (2019). Assessment of storage conditions of medicines in Cameroon. BMC Health Services Research, 19(1), 1–7. https://doi.org/10.1186/s12913-019-4010-2
Musafiri, D., Uwizeye, C., & Kabanda, J. (2018). Evaluation of compliance with good pharmacy practice in Rwanda. Rwanda Journal of Medicine and Health Sciences, 1(2), 67–75.
Mwangi, J., Wambui, L., & Maina, M. (2017). Implementing electronic logistics management systems in Kenya: Impact on supply chain efficiency. East African Medical Journal, 94(10), 811–820.
Nafiu, M. O., Olayemi, S. O., & Fadare, J. O. (2020). Drug storage and distribution challenges in community pharmacies in Nigeria. African Journal of Pharmacy and Pharmacology, 14(3), 68–75. https://doi.org/10.5897/AJPP2019.5120
Ndomondo, P., & Adeola, F. (2020). Strategic context analysis in African SMEs implementing ISO 9001. Journal of African Business, 21(4), 521–540.
Owusu-Daaku, F., & Kretchy, I. (2019). An assessment of pharmaceutical storage and distribution practices in Ghana. International Journal of Pharmacy Practice, 27(3), 256–263.
Schiavetti, B., Wynendaele, E., De Spiegeleer, B., Mbinze, G. J., Kalenda, N., Marini, R., Melotte, V., Hasker, E., Meessen, B., Ravinetto, R., Van der Elst, J., & Mutolo Ngeleka, D. (2018). The quality of medicines used in children and supplied by private pharmaceutical wholesalers in Kinshasa, Democratic Republic of the Congo: A prospective survey. The American Journal of Tropical Medicine and Hygiene, 98(3), 894–903. https://doi.org/10.4269/ajtmh.17-0732
World Health Organization. (2020). Guidelines on good distribution practices (GDP) of pharmaceutical products. WHO Press.
World Health Organization. (2021). The state of pharmaceutical systems in the African region. World Health Organization.
World Health Organization. (2021). Technical report on pharmaceutical systems strengthening in Africa. WHO Press.
World Health Organization. (2022). Good distribution practices: Assessment in African countries. WHO Press.
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