Item Evaluation of the impact of Quality management and Regulatory systems in the manufacturing processes of Albendazole in The Republic of Paraguay and The Republic of Ireland

Abstract

The present dissertation aims to evaluate the impact of Quality management and Regulatory systems on the Albendazole manufacturing processes in the Republics of Paraguay and Ireland.The legal framework and quality managerial procedures of the business as well as its in both countries will be evaluated. When examining the impact of a company's quality system on its products, the opinion of pharmacists and other industry sectors regarding overseas and Paraguayan pharmaceutical industries products would also be considered. This objective would be accomplished through a quantitative questionnaire survey. The results of the survey with 54 participants, including pharmacists, quality officers, and other positions, and a literature review of the regulatory systems and quality management procedures of the pharmaceutical industry revealed that the regulatory framework in Paraguay needs to adjust in order to be able to manufacture Albendazole for exporting to Ireland and that the entire pharmaceutical industry has gaps that need no te adjust the European union quality system. Inaddition, the research was able to recognize the variables that influence the quality and availability of Albendazole products manufactured in Paraguay that comply with Ireland pharmaceutical industries, such as regulations/guidelines for manufacturing of high-quality medicinal products, demand exceeding supply, and high prices for high-quality Albendazole products.

The study recommends that DINAVISA make the Paraguayan Pharmaceutical sector'sactivities more transparent and that additional resources be made available to Paraguayan pharmaceutical industries in order for them to comply with European Union regulations in order to manufacture Albendazole with the same quality