Challenges Impacting Effective Validation Practices Among Pharmaceutical Companies: Towards Improving the Quality of Pharmaceutical Products in Nigeria
This study evaluates the Nigerian market's current state of pharmaceutical validation practices to measure their effectiveness in producing quality drugs and vaccines while comparing it with best practices globally for parity. The aim is to examine various obstacles faced by pharmaceutical companies in Nigeria when attempting to establish robust validation practices. These challenges encompass regulatory inconsistencies, inadequate infrastructure, limited resources, and a shortage of skilled personnel. Such impediments can compromise product quality and safety concerns and diminish public trust in the pharmaceutical sector. The objectives of the study were first to understand the current state of validation practices in the region to test if there is a gap from standardized procedures, to identify challenges impeding full-scale implementation, to examine existing guidelines in Nigeria and their sufficiency in implementing robust validation practices; to review international policies and propose recommendations towards improving the state of validation practices in the region vis a vis enhancing the quality of pharmaceutical products. The study employed a mixed methodology, i.e., online surveys and structured interviews. It collected data from the discussion with 9 experts in the pharmaceutical industry and 56 other professionals who are well-informed about validation practices, its guidelines in Nigeria, and the standards obtainable in developed countries. This research suggests a multi-pronged approach to address these challenges and enhance validation practices. The proposed strategies include strengthening regulatory frameworks, promoting investment in modern infrastructure, fostering collaborations between industry and academia, and providing comprehensive personnel training. By addressing these challenges, the pharmaceutical industry in Nigeria can elevate the quality of its products, ensure compliance with international standards, and ultimately contribute to improving public health outcomes.