104 resultados para Boas práticas de fabricação
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Nas últimas duas décadas, o crescimento do interesse pela metodologia Seis Sigma intensificou a aplicação da abordagem estatística e de outras abordagens quantitativas com o intuito de melhorar não apenas a qualidade de produtos, serviços e processos, como também aumentar o desempenho organizacional e o processo de tomada de decisão. Este artigo trata da aplicação da abordagem estatística no contexto da gestão da qualidade em indústrias de alimentos de médio e grande porte do Estado de São Paulo com o propósito de: identificar quais ferramentas e técnicas estatísticas são mais amplamente empregadas por indústrias do setor para garantir e controlar a qualidade; avaliar a interdependência entre o sucesso da implementação de programas de qualidade e segurança alimentar como Boas Práticas de Fabricação (BPF) e sistema de Análise de Perigos e Pontos Críticos de Controle (APPCC) e o uso de estatística; e analisar estimativas do grau de relevância do pensamento estatístico e de seus benefícios como ferramenta de melhoria da qualidade. Um survey exploratório-descritivo foi realizado e os resultados revelaram que a abordagem estatística começa a ser mais valorizada nas indústrias de alimentos pela relevância de seus benefícios assim como já ocorre em outros setores. Há evidências de que a implantação bem sucedida dos programas de segurança alimentar seja uma condição primordial para o uso efetivo de estatística e de outras abordagens quantitativas.
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Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES)
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Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP)
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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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Pós-graduação em Medicina Veterinária - FCAV
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Lately, the acceptability of fermented dairy beverages has been increased, due to the nutritional benefits, the practical consumption and the low cost of product for the manufacturers, and consequently for final market price to the consumers. During the manufacturing process, these products can be susceptible to microbiological contamination. The present study investigated the contaminant microbiota in fermented dairy beverages produced by small- and medium-sized companies, by means of analyses on moulds and yeasts counting, determination of the Most Probable Number (MPN) of total and thermo tolerant coliforms, Escherichia coli and Salmonella spp. detection, and determination of pH value. In spite of the absence of Salmonella spp., a high counts of yeasts and moulds were found, and E. coli was detected in five samples (16.67 %); and the sample were classified as “products in poor sanitary conditions”, because they showed thermo-tolerant coliforms counting higher than the standard established by the legislation in force. Therefore, quality programs such as Good Manufacturing Practices (GMP) and Hazard Analysis and Critical Control Points (HACCP) should be employed to prevent any contamination risk, in order to provide safe products to consumers.
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Pós-graduação em Medicina Veterinária - FCAV
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Pós-graduação em Medicina Veterinária - FCAV
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The goal of this work is to report some problems that occur in the in the production of aluminum billets (series 6XXX) produced by the hot top process in the Alcoa aluminum Inc. The aluminum fabrication process is described from its first stage, since the mining until the reduction, smelting and treatment of the metal. One of the plant’s final product, are billets for clients that produce profiles by extrusion. The product’s final quality highly depends on the whole production process. Therefore it’s necessary to use good practices in the treatment of the metal, follow up its fabrication and control its thermal treatment, in order to meet the required standards to satisfy the clients. The billet’s production method and its variables will be detailed through temperature and casting speed, cone of water flow, cooling rate, duration of thermal treatment, degassing and metal “in line “filtering, in other words when it’s still found in its liquid state. The non-conformities of the process were studied by metallographic analysis, both macrostutural and microstructural that will be described and discussed in this work
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The civil construction sector has been stimulated to industrialize itself by the adoption of lean production practices in its constructive process. Given this fact, this research verify and identify good practices and difficulties in implementing lean production in construction companies in the State of São Paulo, in order to be able to formulate recommendations to potentiate the performance of the lean concepts applied. The research method used was a multiple case study, where the companies analyzed are constructors that have already initiated the lean application in their systems. From the results, a case analysis was conducted in order to note the constructors' situation in relation to lean construction and, base on this analysis, recommendations were proposed for the companies reflect on lean principles and apply them along to your construction management
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The industries face increasingly fierce competition, so that differentiation becomes more and more difficult. In the case of the branch of machine tool industries this scenario is aggressive, those firms face competition from around the world, which have good quality and low price. This paper aims to propose the creation of a department to promote standardization in a company of special tools. The goal was achieved from survey of theories and applications of quality management, knowledge management and standardization, done by scholars in these areas, which added the use of qualitative study resulted in a proposal that contained not only the creation of this department as possible approaches that can be applied by him. This work is limited to the study of a company that manufactures special tools of the state of São Paulo, which despite its small size and limited number of employees, also presents common situations to other companies in the field, especially with regard to the behavior employees, and present good practices that can be implemented by any company
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Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP)
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Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP)
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Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP)