Avaliação dos processos de trabalho dos centros de material e esterização dos hospitais públicos acreditados do estado de São Paulo: um estudo de caso

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

Regulamentação Sanitária de Medicamentos

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.

The impact of the law 10,267/2001 in the brazilian rural registration

The publication of the Law 10,267 of 08/28/2001 changed the paradigm of rural registration in Brazil, because this law known as the Law of Georeferencing has created the National Registration of Rural Property, that unifies in a common basis different registrations present in several government agencies, such as the National Institute for Colonization and Agrarian Reform (INCRA), the Secretariat of Federal Revenue, the Brazilian Institute of Environment and Natural Resources, and the National Indian Foundation. Also, this new registration system has a graphical component which has not existed until such date, where the boundaries of rural property are georeferenced to the Brazilian Geodetic System. This new paradigm has resulted in a standardization of the survey and its representation of rural properties according to the Technical Standard for Georeferencing of Rural Properties, published by INCRA in compliance with the new legislation. Due to the georeferencing, the creation of a public GIS of free access on the Internet was possible. Among the difficulties found it may be observed the great Brazilian territory, the need for specialized professionals, and especially the certification process that INCRA has to perform for each georeferenced property. It is hoped that this last difficulty is solved with the implementation of the Land Management System that will allow automated and online certification, making the process more transparent, agile and fast.

Sistema orgânico de produção de pescado de água doce

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

Sistemas de gestão da qualidade ISO 9001: survey sobre os desafios da implantação

Pós-graduação em Engenharia de Produção - FEB

Produção e comercialização de alimentos orgânicos: relações comerciais Brasil - União Européia

O objetivo do presente trabalho é o entendimento da dinâmica do mercado dos alimentos orgânicos no Brasil, sua cadeia produtiva e as relações comerciais estabelecidas especificamente com a União Européia. Apesar do segmento orgânico crescer a altas taxas ao redor do mundo, ainda é uma temática (promissora) pouco estudada nacionalmente, o que dificulta o desenvolvimento de processos que poderiam diminuir os entraves enfrentados pelos produtores orgânicos. Inicialmente situando o leitor sobre as origens do cultivo orgânico e apresentando o panorama mundial atual, o trabalho entra no cenário nacional discutindo o perfil do produtor, o paralelo entre insumos tradicionais e aqueles específicos para a produção orgânica, além das dificuldades de financiamento em âmbito nacional. Em seguida, discute-se questões relativas à comercialização: qual o perfil do produtor e quais os sistemas de distribuição da produção orgânica nacional e internacional; o porquê dos preços de produtos orgânicos exibirem margens de lucro tão altas; de onde vem a necessidade de certificar a produção, quais as principais certificadoras e seus métodos de atuação. A partir deste embasamento, pode-se trabalhar, então, as relações comerciais estabelecidas entre o Brasil e a União Européia, bloco de destino de mais de 70% da produção orgânica nacional; trata-se, então, das leis e das certificações necessárias para efetuar as exportações; dos principais produtos exportados dentro do segmento orgânico e das 19 empresas responsáveis por essas exportações. Percebe-se, por fim, que um dos principais entraves ao desenvolvimento do segmento ainda é a falta de investimentos em P&D, pois a carência de dados sistematizados e pesquisas em geral acabam por desestimular tanto produtores quanto consumidores em busca de informações sobre esse mercado pouco evidenciado nacionalmente

Impacto da ABNT NBR 15575 na qualidade da construção civil

The quality in construction is increasingly a concern in this sector, in view of the occurrence of problems in civil works, even when a contractor is certified by ISO 9001. The ISO 9001 certification does not ensure the maintenance of quality because it only establishes the requirements for a quality management system (QMS) to ensure standardization of processes and products. With the development of ISO 15575, standard performance, the builders took on a quality parameter with the requirements established by this Standard, which must be met. Thus, the implementation of a quality management system (QMS) becomes essential, showing users the concern for quality. This study aimed to verify, through a case study, the impact of NBR 15575 quality construction and how that standard of performance may be the key element of ISO 9001 to ensure quality maintenance of civil works

Análise do Programa Município VerdeAzul na Unidade de Gerenciamento de Recursos Hidricos do Pontal do Paranapanema

The increasing degradation of the environment and the depletion of natural resources, caused by indiscriminate production practices, by current and unlimited human needs and also misconceptions that natural resources are inexhaustible, make current and future environment situation, a constant concern of national and world leaders. With the purpose to confront these issues and to qualify the cities on the environmental situation in the state of São Paulo, the Department of the Environment created, in 2007, the Program “Município VerdeAzul. This paper aims to the study this program of Unit Water Resources Management Pontal Paranapanema through specific analysis of data representing the efficiency of the program directives and a comparative study between two cities unit with discrepant scores and a survey of the possible causes of obtaining low scores for municipalities participating in the project. For such a method was used that consisted of a bibliographical survey related to the main environmental liabilities Brazilians... (Complete abstract click electronic access below)

Avaliação do potencial de microgeração em despacho econômico para atendimento aos requisitos de etiquetagem de edifícios

The discussions about the energy rationalization are gaining more and more space on the everyday of engineers and other professionals in the field of energy. A greater focus is being tied to commercial buildings, because they are one of the biggest responsible for the high energetic expenditure according to the National Energetic Balance, especially by the use of air conditioners for the people’s thermal comfort. Such finding made INMETRO to develop a building labeling procedure through th National Program of Electric Energy Conservation in Buildings; by means of this systematic, the built areas are classified by levels that go from A(the best) to E(the worst), taking into account envelopment, illumination system and air conditioning. A bonus process based on water rationalization, use of renewable energy sources, cogeneration systems or technical innovations, allows the classification to be changed up to one level. A study made exactly on a commercial building, the building of Foundation for Technological and Scientific Development located inside of the College of Engineering of Guaratinguetá, sought to identify technical/economic alternatives for the building certification and appealed to the bonus based on water rationalization. The present study is based on analysis of deploying a cogeneration system formed by internal combustion engine and an absorption refrigeration system as bonus alternative, so that the costs are analyzed regarding energy consumption and use of the motor. With the calculations and results, the viability of the building to receive a bonus from INMETRO through its National Program for Energy Conservation in Buildings is studied and concluded from this study whether or not you can get a better level of energy efficiency for the building in question... (Complete abstract click electronic access below)

Proposta de sistemática operacional para implantação de sistemas de gestão ambiental em empreendimentos industriais

The implantation of environmental management systens (SGA) in companies is the first step to the company conquers the environmental certification and consequently the benefits of a sustainable production of products, services and activities can bring. However, in the way as they are proposals in bibliographies the implantation of the SGAs, does not identify the definition of the operational stages of implementation of the same ones, generating doubts on the real environmental and administrative performance that they can come to generate for the organization. In this direction, the present research brings a proposal of operational systematics for implantation of SGA in companies, detailing each stage of implantation, considering its particularitities. For in such a way, a revision of norm NBR ISO 14001:2004 was made, looking for to identify to the interpretation imperfections gifts in the normative system. Moreover, other methods of SGA implantation had been searched gifts in the bibliography, searching proposals that detailed the operational aspects of the implantation of the system. In the same way, the accomplishment of a period of training supervised in the first semester of 2007 made possible the practical experience of the functioning of a system of environmental management, beyond the contact with professionals of the area and the acquisition of documents that had helped in the development of the research. The result was the attainment of a detailed procedure more, defining the operational systematic of SGA implantation, beyond the generation of a flowchart, describing as to develop each stage. This detailing certainly will facilitate the implantation of a SGA in companies interested in improving its environmental performance.

Técnicas construtivas e procedimentos sustentáveis – estudo de caso: edifício na cidade de São Paulo

The environmental problems generated by construction activity have been widely discussed in Brazil, which has begun to incorporate sustainable building techniques in your ventures. Based on these facts, this work focused on addressing the main characteristics of a sustainable building project. Among them are water conservation, energy efficiency in buildings, managing a construction site with little environmental impact and reuse of materials and construction elements. This work, after the presentation of the main characteristics of a sustainable building project, shows a case study about the implementation of environmental certification LEED Gold level in a large building, located in São Paulo - SP, Brazil. With that, we want to produce a research document about the topic of sustainable buildings

Novas responsabilidades para o professor na educação básica

The goal of this study was to identify some of the new responsibilities that have been assigned to the elementary school teachers , under the mediation of continuing education courses . We start from the idea that these courses , especially those offered by the SECADI, are proposed teachers and aims to train them for a performance at school that exceeds the activity of teaching in the classroom . The teacher has been summoned to attend these courses in which is prepared to act on school performing tasks rather related to the care of students than teaching , assisting them in their basic needs such as health, protection, inclusion and human rights. Asked ourselves if there was a reconfiguration of the responsibilities of education professionals in order to make use of oneself given by the State. We chose as sources of research documents the SECADI such as legislation , manuals and instructional materials that will proceed to the analysis , in each course , the target populations privileged , purpose, remuneration and certification , pre - requirements to participate in the courses and duration ; partnerships involved if the courses are face , semi-distance or distance ; activities that teacher should develop in school after completion of the courses ; loads hourly . We will seek to analyze the documents and materials of School programs that Protects, School Health Program , Network Education for Diversity. The theoretical and methodological framework is dialectical and historical materialism, from assumptions which we choose as the class character of society in capitalism and alienation as a phenomenon that affects the work in all its manifestations . Thus , our general hypothesis is that the enrichment tasks of teachers in public schools can contribute to basic disposition Teacher education

Avaliação do desempenho ambiental da produção canavieira com colheita mecanizada: contribuição à implantação de um sistema simplificado de gestão ambiental da propriedade

The consuming of the natural resources in the agricultural sector does not represent only one external factor of the productive process, but also it implies in a bigger cost for the production, justified for this environmental degradation. In view of the necessity of evaluating the sustainment of the agricultural businesses, the use of performance indicators if makes of extreme importance. The measurement of the support through environmentalindicators is one of the most accepted forms of performing the evaluation of one given agricultural activity. In this context, the Base System for Eco-certification of Agricultural Businesses (Eco-cert Rural) developed by the Embrapa Environment at Jaguariúna/SP, has for purpose to present a method of evaluation of the agricultural businesses, not only of the point of view of the ecological performance, as well as considering the social, economic and organizational aspects. Through the analysis of the performance of the activity and the regularization of the disconformities found, it makes possible the eco-certification of the activities in the varied existing protocols, offering technologies designed to the sustainable development of the agricultural businesses. Using Eco-cert.Rural, this work evaluated the contribution of the use of mechanized harvest in sugar cane handling, front to the traditional system of manual harvest, using the fire. In the Sugar Cane Activity General Performance Index, Agrícola Rio Claro scored 2,08 of a maximum of 15. Amongst all the indicators, those wich reached performance worse had been related to the Use of Energy and the Income, by increasing fossil fuel consumptiom, and implying income concentration due to resignations of rural workers. However, the improvements on the environment quality by supressing manual harvest through fire are very significant. Beyond the great reduction in...(Complete abstract click electronic access below)

Análise da implantação das certificações ambientais LEED e AQUA: estudo de caso em alguns empreendimentos

Given the large potential impact that the construction industry has on the environment and the need to reduce environmental degradation , environmental certifications are important tools of environmental management. This work deals with the environmental certifications of sustainable buildings LEED and AQUA . This project employed the method of exploratory research to identify the requirements that impose the greatest difficulties in the implementation of LEED and AQUA , surveying the reasons for the choice of certification to be deployed and to analyzing the main benefits perceived by certified organizations. Concepts related to the topic were obtained from the literature, leading to the development of a questionnaire that was applied in organizations that have gone through the above certifications . From the analysis of questionnaires, it was possible to highlight that the main reasons for the adoption of an environmental certificate in the construction industry are linked to economic issues such as greater market recognition and appreciation of the project and what is still needed to invest in environmental awareness industry and the whole society

Criação de novo procedimento de engenharia que possibilite a rastreabilidade das tubulações de uma indústria química

The number of piping in an industry is high. Through this piping are conducted several kind of products at several temperature and pressure conditions. In a chemical company, the piping quantity conducting harmful chemical products to human health and to the environment is higher. Nowadays the theme sustainability is often mentioned and harm to environment may cause irreversible damage to the human being, to the fauna, to the flora and to company´s credibility. In this context, controlling over the piping to avoid accidents is mandatory. The objective of this monograph is to create a procedure which enables the chemical companies piping traceability. This monograph analyses the several existent traceability system in the three economy sectors and approaches the technical question of industrial piping in order to create a procedure that achieves its objectives as a technical document and at the same time be economically feasible, with low complexibility level and high practicability. Some possibilities to elaborate this procedure had been studied, as the creation of an alphanumeric code and making with a chisel in the pipeline based on ASTM F2897 and the use of chips to store the information. However, the procedure which best meet the requirement as low cost and high applicability is filling out an electronic plan with information about welding process, welding certification, welding consumables and inspections