174 resultados para Manufacturers


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Pós-graduação em Odontologia Restauradora - ICT

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Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES)

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A regulamentação sanitária de medicamentos é uma das oito diretrizes da Política Nacional de Medicamentos. Trata-se da fiscalização e regulamentação de registro de medicamentos e da autorização de funcionamento desde os produtores até o varejo de medicamentos, bem como das restrições àqueles sujeitos a controle especial. A regulamentação sanitária de medicamentos tem como objetivo garantir eficácia, segurança, qualidade e custo aos produtos farmacêuticos. Os estudos clínicos dos medicamentos de Referência, a bioequivalência ou biodisponibilidade relativa e testes de equivalência dos medicamentos similares e genéricos são meios de avaliar a eficácia e a segurança. A qualidade é garantida lote a lote pelas Boas Práticas de Fabricação e Controle dos produtos farmacêuticos e a certificação da empresa pela ANVISA. O custo é avaliado pela câmara técnica de medicamento (CMED), que estabelece os critérios para fixação e ajuste de preços dos produtos farmacêuticos. No pós-registro, a efetividade, segurança e qualidade dos produtos são avaliadas por meio das comprovações exigidas na renovação do registro e, principalmente, pelo programa de farmacovigilância. Palavras-chave: Registro de Produtos. Medicamentos de Referência. Medicamentos Similares. Medicamentos Genéricos. Alteração de Registro de Produtos. ABSTRACT Health Regulations for Drugs The health regulation of drugs is one of eight guidelines issued within the National Drug Policy. It refers to the supervision and regulation of drug registration and the approval of operations, from the manufacturers to the retailers of medicines, as well as the restrictions that apply to drugs under special control. The health regulation of medicines is aimed at controlling the effectiveness, safety, quality and cost of pharmaceutical products. Clinical studies of brand-name (innovator) medicines, bioequivalence or relative bioavailability and the equivalence tests of generic and ‘similar’ brand-name drugs are means used to assess efficacy and safety. Quality is assured on a batch-to-batch basis by compliance with the Good Manufacturing Practices and Control of pharmaceutical products and by the certification of companies offered by ANVISA. The cost of a medicine is assessed by the Technical Chamber of Medicine (CMED), which establishes the criteria for setting and adjusting the prices of pharmaceutical products. After registration, the effectiveness, safety and quality of products are monitored by means of the tests required on renewal of registration and especially by the pharmacovigilance program. Keywords: Product Registration. Original Brand-name Drugs. Similar Drugs. Generic Drugs. Modification of Product Registration.

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The lack of risk management can generate disruption in the supply chain, and there is little literature related to the aerospace industry. This article aims at identifying the risk factors for supply chain of the main Brazilian aircraft manufacturer. Nine risk factors specific to aircraft manufacturers were identified: Environmental, Natural and Political, Supply Chain, Business Strategy, Product Management, Indicators, Organization, Productivity, and Quality and Information System. These factors were quantitatively evaluated with respect to their criticality using the Analytic Hierarchy Process (AHP). The Quality and Productivity factors were considered the most relevant in this study, which can be classified as a single case study. The necessary data were obtained through interviews with professionals from different areas of the studied enterprise.

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Pós-graduação em Design - FAAC

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Pós-graduação em Agronomia (Energia na Agricultura) - FCA

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Pós-graduação em Agronomia (Energia na Agricultura) - FCA

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Pós-graduação em Agronomia (Energia na Agricultura) - FCA

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Human health and environmental concerns are not usually considered at the same time. Tin-lead solders are still widely used in several countries, including Brazil, by manufacturers of electronic assemblies. One of the options to reduce or eliminate lead from the manufacturing environment is its replacement with lead-free alloys. This paper applies emergy synthesis and the DALY indicator (Disability Adjusted Life Years) to assess the impact of manufacturing soft solder using tin, lead and other metals on the environment and on human health. The results are presented together with the company's financial results and the results calculated from the Brazilian statistical value of life. The calculation of emergy per unit showed that more resources are used to produce one ton of lead-free solders than to produce one ton of tin-lead solders, with and without the use of consumer waste recovered through a reverse logistics system. The assessment of air emissions during solder production shows that the benefits of the lead-free solution are limited to the stages of manufacturing and assembling. The tin-lead solder appears as the best option in terms of resource use efficiency and with respect to emissions into the atmosphere when the mining stage is included. A discussion on the influence of the system's boundaries on the decision-making process for materials substitution is presented. (C) 2012 Elsevier Ltd. All rights reserved.

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Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq)

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Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP)