Diseño de un manual de buenas prácticas de manufactura para la empresa Laboratorio Génesis ubicada en la provincia de Tungurahua en la ciudad de Ambato

Abstract

The main objective of this work is the development of a manual of Good Manufacturing Practices (GMP) for the company Génesis Laboratory LABGENESIS CIA. LTDA. For its effect, a diagnosis of the initial situation of the company was carried out, having an average compliance of 48 percent, a value that indicates that the company requires an intervention to improve certain aspects of non-compliance. Once the inconsistencies were determined, an improvement plan was developed to develop them in the company, thus the execution of the changes was carried out generating an increase of 40 percent of compliance with the GMP regulations for pharmaceutical laboratories of medicines in general. Finally, the improvements achieved were evaluated, resulting in a final total compliance of 88 percent, which highlights that the work carried out was assertive in the aspects of greatest deficiency found in accordance with the GMP regulation.