Anticiper les conséquences de la non-conformité aux règles GMP sur la chaîne logistique de l'industrie pharmaceutique

Abstract

This study examines the critical area of the pharmaceutical industry, focusing on the potential ramifications stemming from non-compliance with Good Manufacturing Practice (GMP) regulations within the supply chain. The objective is to analyze the repercussions of failing to adhere to GMP rules and to provide an overview of anticipation and mitigation strategies. The research emphasizes the significance of GMP compliance in safeguarding pharmaceutical product quality, integrity, and safety throughout the supply chain. Drawing on a combination of regulatory analysis, case studies, and input from industry stakeholders, the study provides a comprehensive view of the potential consequences that can arise due to non-conformity with GMP regulations. The anticipatory solutions proposed as part of thesis pertain to the measures outlined in this research paper, which include relocation subcontractors closer to the market, diversifying suppliers, driving internal and external audits, building strong partnerships with suppliers and logistics service providers, using advanced tracking and traceability technologies, prioritizing customer satisfaction, managing controlled safety stocks, ensuring managed business continuity in the event of supply chain disruptions, and implementing rigorous staff training. A more comprehensive approach has been considered by contemplating the integration of blockchain technology into the field. These implications extend beyond the business realm, directly impacting patient safety and well-being. However, it is important to recognize certain limitations of this study. The research focuses on a limited sample of pharmaceutical companies, which potentially limits the generalizability of the results. Variation in the application of GMP across different companies may introduce biases into the analysis. In addition, the dynamic nature of external factors influencing the pharmaceutical industry requires future research to comprehensively address all aspects.