1A comparative study of Regulatory systems and Quality management practices in the manufacturing process of different pharmaceutical companies in Nigeria.

Awele, Anyiam Chioma (2021) 1A comparative study of Regulatory systems and Quality management practices in the manufacturing process of different pharmaceutical companies in Nigeria. Masters thesis, Innopharma.

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Abstract

This thesis aims to examine and compare different pharmaceutical manufacturing companies in Nigeria(local and foreign). There will be an examination of regulatory systems and quality management practices in the company and their impact on the quality and availability of medicinal products in the region. The opinion of medical doctors, pharmacists and consumers concerning the products from foreign and Nigerian pharmaceutical companies would also be considered when examining the impact of company quality system on the products. This aim would be achieved by way of conducting quantitative questionnaire survey and qualitative reviews of literature.A cross-sectional survey with 50 participants including medical doctors, pharmacists and consumers was carried out and literature about the regulatory systems and quality management practices of the were reviewed and the results showed the regulatory system in Nigeria is not effective and the entire pharmaceutical sector of has loopholes that make the system inefficient. The research was also able to identify the factors that influence the quality and availability of medicinal products manufactured in Nigeria which include Socio Economic status of the country,Inadequate laws or poor enforcement of the existing regulations/guidelines for manufacturing of good quality medicinal products,Inadequate funding/support for Nigerian pharmaceutical manufacturing companies,Demand exceeding supply and high cost of good quality medicinal product. NAFDAC has put in efforts over the years to improve their system but there are still important changes that need to be made. The study recommend that NAFDAC makes the Nigerian Pharmaceutical sector more transparent with its activities and more funding should be made available to the Nigerian pharmaceutical companies. Also should be set up to ensure that the NAFDAC officials carry out their duties effectively and they should be paid properly for it.

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