The Role and Impact of Process Analytical Technology (PAT) on Solid Dose Manufacturing in Nigeria
This research investigated the role and impact of Process Analytical Technology (PAT) on solid dose manufacturing in the Nigerian pharmaceutical industry. PAT has been generally adjudged to be a promising technology that can significantly improve manufacturing efficiency and reduce the cost of production. There is evidence to back this point of view based on the automotive industry and other industries that have successfully implemented PAT. However, regardless of the demonstrated benefits of PAT, manufacturers in the pharmaceutical industry seem too slow to implement it in their manufacturing process. Realising this, the United States Food and Drug Administration (FDA) enacted a series of initiatives to drive a regulatory framework that could motivate manufacturers in the pharmaceutical industry to implement PAT. Nigeria represents one of the biggest pharmaceutical market in the world by virtue of its population which is estimated to be the biggest in Africa where PAT could help deliver quality medication at affordable rates. To investigate the role and impact of PAT in the Nigerian pharmaceutical industry, this research adopted a quantitative approach whereby self-administered questionnaires were sent to manufacturers through an online Google Form. The list of registered pharmaceutical manufacturers was obtained from NAFDAC, the regulator of the industry in Nigeria. Out of about 130 established manufacturers, 62 responses were obtained. Based on inferential statistics, the results show that indeed PAT plays a role in the Nigerian pharmaceutical industry albeit an insignificant one. Out of about twenty-one (21) identified challenges, eleven (11) were statistically significant. The most significant challenges that the respondents agreed the strongest to relate to the cost of implementing PAT. Although the hypotheses tested revealed that PAT has a significant effect on the price, quality and effectiveness of solid dosage forms, the general experience of health practitioners could not justify PAT adoption. Therefore, it is recommended that manufacturers in the Nigerian pharmaceutical industry must think long term in order to overcome the hurdle of the initial cost of implementing PAT. The regulator of the industry must find strategies of making pharmaceutical manufacturing attractive so as to drive innovation from the manufacturers.