La calidad desde el diseño ofrece ventajas sobre modelos previos de aseguramiento de la calidad, siendo útil en sectores donde la calidad signifique diferenciación y la flexibilización de los procesos estimule el mejoramiento continuo y la innovación. Como una contribución para facilitar su implementación en la industria farmacéutica en Colombia, en el presente artículo se analizan las circunstancias que la originaron. Igualmente, partiendo de un estudio de literatura especializada, se explica su importancia en el desarrollo de productos y se proponen algunos aspectos metodológicos para su puesta en práctica. La evidencia reportada sugiere que esta nueva visión de la calidad es una estrategia que genera confianza en clientes, industria y organismos reguladores, respecto a la calidad de los productos farmacéuticos.Quality by design offers advantages over previous quality assurance models, being useful in areas where quality means the differentiation and implementation of flexible processes to stimulate continuous improvement and innovation. As a contribution to making quality by design easier to implement in the Colombian pharmaceutical industry, this paper discusses why this concept was originated. Likewise, based on a literature analysis, the noteworthiness of quality by design when products are being developed is discussed, and methodological strategies for its accomplishment are proposed. The reported evidence suggests that quality by design builds consumer, industrial and regulatory confidence on the quality of pharmaceutical products
Biopolymers have been widely studied for use in pharmaceutical applications. They have been used for modifying drug release, orientating a drug towards its therapeutic target, penetrating physiological barriers (tissues and cells) and protecting unstable therapeutic agents against physiological conditions which are present in a less invasive administration routes. The importance of biopolymers in designing new biomedical devices must thus be stressed, especially when a pharmaceutical substance must be incorporated into a polymer matrix. A new generation of alternatives for human health has thus been generated by designing pharmaceutical therapeutic systems in line with the concept of “integrated custom-made product design”. This document reviews the trends concerning using biopolymers for designing products having pharmaceutical and biomedical applications. The paper also introduces the elements which should be mastered by engineers for obtaining material which can be used in the health field and tries to provide a reference point regarding the state of the art in this specific field of knowledge.
Propuesta de una metodología para el estudio de competencia tecnológica una de las variables y cómo su relación permitiría establecer criterios de comparación entre empresas del mismo sector. Se aplicó una encuesta en 22 laboratorios de producción de medicamentos y los datos obtenidos fueron analizados a través de la estrategia metodológica propuesta. Palabras clave: competencia tecnológica, desarrollo tecnológico, modelo descriptivo, producción de medicamentos.
The pharmaceutical industrial has five subsectors: medicines, cosmetics, phytotherapeutics, cleaning products and medical devices. The medicine subsector consists of organisations producing, importing and selling these products. Most studies about this industry have been guided by economic interests without assessing technological aspects of production. This article was aimed at proposing a methodology for assessing and describing the medicine sector according to its technological development by using the manufacturing capability concept. The main information was taken from the Colombian Medicaments and Food Surveillance Institutes (Instituto Nacional de Vigilancia de Medicamentos y Alimentos - INVIMA) databases related to pharmaceutical plant production in Bogotá, including material transformation facilities. This study led to three characteristics being identified for defining the pharmaceutical industrys manufacturing capability: that related to the pharmacological group to which active pharmaceutical ingredients belong, that linked to specifications regarding medicines sterility and that related to the technology required for manufacturing each pharmaceutical product. An analysis of these features has thus been presented and some technologies have been identified which have not been transferred or assimilated by the organisations being studied. It was found that manufacturing capability should be considered as being an indicator of the degree of technological development in these subsectors in Colombia.
Some conceptual elements regarding the axiomatic design method were applied to a specific case-study regarding developing modified liberation compressed product (CLM-UN), for use in the agricultural sector as pH regulating agent in soil. The study was orientated towards defining functional requirements, design parameters and process variables for manufacturing the product. Independence and information were evaluated, supporting axiomatic design as an alternative for integral product and process design (as a rational and systemic exercise), facilitating producing products having the quality which future users expect from them.
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