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Evaluation of the cost-benefit of the implementation of PAT systems for the production of solid forms in a pharmaceutical company
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Resumo(s)
Process Analytical Technology (PAT) is defined by the FDA in the PAT initiative issued in 2004 as ”a system for designing, analyzing, and controlling manufacturing through timelymeasurements (i.e.,during processing) of critical quality and performance attributes of raw and inprocess materials and processes, with the goal of ensuring the final product quality”. Since then, the pharmaceutical companies have been adopting gradually this technology in their manufacturing lines. PAT tools are indeed well recognized as a critical tool for achieving better process and product control leading to the possibility of real time release testing. This thesis evaluated the technical and economic feasibility of implementation of PAT systems into a Portuguese pharmaceutical company manufacturing line of solid forms. To accomplish this task, two products were used as models. These products were selected since they cover most unit operations of the solid forms installed manufacturing line. The work was divided in two parts. The first part is concerned with the identification of critical quality attributes (CQAs) and critical process parameters (CPPs) of the two model products in order for the proposition of opportunities of implementation of PAT strategies. These opportunities are described in detail and evaluated according to a series of criteria. Nine opportunities were identified, mainly involving NIR and RAMAN spectroscopy as suitable technology. The implementation of the identified opportunities, is expected to permit the possibility of real time release for the two products. The second part focuses on the economical feasibility of the identified PAT implementation. The economic analysis indicated that the implementation of all opportunities will reduce manufacturing / quality control time and costs substantially. The expectation of return-of-investmentis achieved in a time frame between 5 to 8 years respectively considering optimistic and pessimist scenarios.
Descrição
Tese de mestrado, Engenharia Farmacêutica, Universidade de Lisboa, Faculdade de Farmácia, 2016
Palavras-chave
Process Analytical Technology Near Infrared Quality-by-design Economic analysis Real time release Teses de mestrado - 2016