A REVIEW OF THE STABILITY STUDIES AND QUALITY ASSURANCE OF PHARMACEUTICAL PRODUCTS ACROSS SUPPLY CHAIN SYSTEMS IN NIGERIA

Ugodi G. W.*, Okolie U. S.

ABSTRACT

Regulating drug quality throughout distribution is a crucial process. Medicines come in a variety of dose forms, such as pills, syrups, injectable, etc., each of which must be kept under specific environmental conditions based on drug stability. Pharmaceutical supply chain in Nigeria suffers many challenges that hinder the proper provision of medicines. This review discussed the elements including structural, regulatory and logistical issues that affect the stability and quality assurance of pharmaceutical products across different supply chains in Nigeria, and proffers solutions to the identified challenges. A thorough literature search was systematically carried out amongst the top recent articles in reputable journals and World Health Organization (WHO) publications in which topics on the supply chains and their challenges on quality assurance of pharmaceutical products, especially in Nigeria were published. Findings from recent articles revealed that a thorough grasp of supply chain administration is required in order to handle the distribution of medicines appropriately. Literature findings also revealed that unauthorized pharmaceutical distribution chains in Nigeria contribute to poor stability and quality assurance of pharmaceutical products across supply chains in Nigeria. In contrast to Nigeria, pharmaceutical supply chains in the UK, USA, and India maintain stricter controls during distribution to ensure medicine availability without increasing wastage. Self-inspections should be carried out to track the application and adherence to Good Distribution Practice and to make necessary recommendations. Correctional and preventative actions are essential to maintaining compliance and product quality throughout the supply chain. The recommended documentation system should comprise data, procedures, instructions, protocols, contracts, records, certificates of analysis, and product specifications, particularly for importers, and should be accessible for auditing and regulatory inspection. Effective supply chain management and planning are required to ensure product availability while minimizing waste across pharmaceutical supply chain stages.

Keywords: Stability Studies, Nigeria, supply chain, stability testing, quality assurance.