35 resultados para Good manufacturing practice
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Pós-graduação em Agronomia (Energia na Agricultura) - FCA
Boas práticas de fabricação (bpf), análise de tomate e água em restaurantes da cidade de Botucatu-SP
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Pós-graduação em Agronomia (Energia na Agricultura) - FCA
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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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In order to assure the maintenance of foods integrity and quality, for avoiding chemical, physical or biological contamination, it is essential to follow the Good Manufacturing Practices (GMP). Among the techniques used for evaluating GMP there is the observational analysis carried out by means of a check-list form application. The present study evaluated the suitability of GMP in a dairy industry producer of Minas fresh and ricotta cheeses, located in São José do Rio Preto, SP, by applying a check-list form. A significant improvement in conformity was evidenced, increasing from 43% to 78%. Neither the blocks related to the handlers nor the existing documentation in the company showed any improvements, as poor conditions unchanged. All of the other evaluated blocks showed significant improvement after applying the GMPrelated corrective measures. Based on these findings, the observance of corrective measures by the dairy industry on dairy products, physical environment, GMP, and handlers training was crucial for assuring the improvements and to increase the product quality and consumers safety.
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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 Educação - FFC
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Food contamination caused by enteric pathogens is a major cause of diarrheal disease worldwide, resulting in high morbidity and mortality and significant economic losses. Bacteria are important agents of foodborne diseases, particularly diarrheagenic Escherichia coli. The present study assessed the genetic diversity and antimicrobial resistance of E. coli isolates from pasteurized milk processed in 21 dairies in northwestern State of Parana, Brazil. The 95 E. coli isolates were subjected to antimicrobial susceptibility testing according to the recommendations of the Clinical and Laboratory Standards Institute and assessed genotypically by Enterobacterial Repetitive Intergenic Consensus-Polymerase Chain Reaction (ERIC-PCR). The highest rate of resistance was observed for cephalothin (55.78%). ERIC-PCR revealed high genetic diversity, clustering the 95 bacterial isolates into 90 different genotypic patterns. These results showed a heterogeneous population of E. coli in milk samples produced in the northwestern region of Parana and the need for good manufacturing practices throughout the processing of pasteurized milk to reduce the risk of foodborne illnesses.
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Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES)
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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 objective of this work was to verify the rational use of energy in restaurants of the city Botucatu, that apply the Good Manufacturing of Production (GMP). Ten restaurants were appraised regarding the number of meals and energy consumption. A check list of the sanitary surveillance was also applied, regarding just the related items to electric installation, ventilation, and equipment maintenance, that are related to the energy consumption. It was asked and observed if there were some program or orientation for conscious consumption or reduction of the energy consumption. The energy consumption of the restaurants was positively related to the number of served meals and operation time of the establishment. In none of the visited establishments it was observed the control measures of the energy consumption, neither cooling equipments of low energy consumption.
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In the minimization of tool switches problem we seek a sequence to process a set of jobs so that the number of tool switches required is minimized. In this work different variations of a heuristic based on partial ordered job sequences are implemented and evaluated. All variations adopt a depth first strategy of the enumeration tree. The computational test results indicate that good results can be obtained by a variation which keeps the best three branches at each node of the enumeration tree, and randomly choose, among all active nodes, the next node to branch when backtracking.
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Dance is regarded as one of the oldest art forms, which is based on evidence from prehistoric paintings found in caves; man expressed himself through body language prior to the development of spoken and written forms of communication. Dance was then used during important events, common to their era and culture, and often in religious rituals, to ensure good harvests - their economic activity. Belly-dance appeared approximately eight thousand years B. C. E. as a sacred dance firstly practiced by priestesses, and after that, it was popularized amongst women from Mesopotamia. Virtually considered an ancient form of physical exercise, it is still practiced by Bedouin women as a preparation for spontaneous delivery. In Brazil, belly-dance is widely practiced and our corporal culture enables its learning and improvement, resulting in professional dancers.
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Pós-graduação em Medicina Veterinária - FMVZ