Examinando por Materia "Pharmaceutic Aids"

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Reducción del tiempo de analisis del excipiente farmacéutico lactosa monohidrato en laboratorios AC Farma S.A., distrito de Ate, 2019–2022
(Universidad Privada Norbert Wiener, 2024-02-28) Pacora Astorga, Monica Pamela; Pinedo Panduro, Lauro Sócrates
Objective: To establish whether it is feasible to implement a reduction in the analysis time of the pharmaceutical excipient lactose monohydrate in a pharmaceutical laboratory during the period 2019–2022. Method: Inductive method through data collection, descriptive level, quantitative approach, basic type, non-experimental design, cross-sectional. The variable corresponds to the pharmaceutical excipient lactose monohydrate, whose dimensions were validated by three specialists. The population consisted of 34 batches of the excipient entered between 2019 and 2022. The applied techniques were survey and documentary analysis, using a questionnaire and a data capture sheet as instruments. Documentary evaluation was carried out to verify compliance with technical standards, personnel qualification, and the existence of an implemented quality system. Results: The documentary evaluation verified that both manufacturer and supplier complied with international standards, with results of 91.3% and 81.11%, respectively. Evaluation and monitoring of manufacturer and supplier performance yielded an average of 98.5% across the four years assessed, meeting the established parameters of 80% to 100%. Analytical results from both the laboratory and the supplier were within specifications, with approved outcomes. Conclusion: It was concluded that the analysis time of the pharmaceutical excipient lactose monohydrate can be reduced from five days to one day, since seven out of the nine tests established by the international USP standard can be omitted by relying on the manufacturer’s results.