Integração de processos dos sistemas gestão da qualidade, segurança e saúde ocupacional, meio ambiente em laboratórios farmacêuticos

Introdução: Por conta da regulamentação sanitária, o sistema de gestão da qualidade nas indústrias farmacêuticas é compulsório e regularmente avaliado pelos órgãos sanitários com relação à adequação às boas práticas de fabricação (BPF). Entretanto, a regulamentação sanitária não se estende às preocupações com a saúde e segurança ocupacional e com o meio ambiente. É importante amadurecer os sistemas de gestão destas temáticas. Objetivo: Estudar a potencialidade de integração dos sistemas de segurança e saúde ocupacional, meio ambiente e qualidade de laboratórios farmacêuticos levando em consideração as premissas, os requisitos regulatórios e as particularidades do segmento. Método: Estudo exploratório e descritivo realizado por meio de pesquisa documental e de campo. Foram construídas matrizes de correlação de requisitos das normas temáticas, mapeadas e propostas ações para integração e em sequência submetida a avaliação por especialistas. Resultados: Comparando as RDC n° 301/2019 e n° 652/2022 com o ICH Q10, ISO 9001, 45001 e 14001, constatou-se que, para 71% dos temas e requisitos normativos, há sinergia e convergência total entre os requerimentos. Para os demais itens são necessárias adequações de processos e condutas. As proposições elencadas pelos autores para tratar as lacunas foram validadas positivamente com relação ao parâmetro viabilidade de implementação em cerca de 90%. Com relação ao benefício positivo, a avaliação foi unânime em 100% e, para a concretização dos tópicos elencados, para 66% dos pontos há necessidade de grande esforço institucional. Conclusões: A integração de um sistema de gestão que incorpore as temáticas qualidade, saúde e segurança e meio ambiente é possível e benéfica para a indústria farmacêutica e suportaria a definição de estratégias, priorizações de ações e alocação de recursos

Encomenda tecnológica e transferência de tecnologia da vacina para COVID-19 no Brasil: um estudo de caso do modelo utilizado pela AstraZeneca/Oxford e Fiocruz

Introduction: The COVID-19 pandemic, caused by SARS-CoV-2, showed a rapid increase in the number of cases and deaths in the five continents, with a major impact in the public health and the economy of the countries. The effects of COVID-19 have highlighted an increase in existing inequalities in society. A global mobilization for the development and rapid production of vaccines was needed to meet the emergency demand caused by COVID-19. Objective: To discuss actions carried out by Fiocruz in the challenges imposed by the emergency to combat the disease, in addition to analyzing and discussing the partnership established between Bio-Manguinhos/Fiocruz and AstraZeneca, through Technological Order (ETEC), aiming at the verticalized Technology Transfer (TT) of the CHADOX1 NCOV-19 vaccine. Method: A documentary analysis of a descriptive nature and qualitative approach was carried out, based on the search for scientific articles on the subject, and institutional documents, as well as a thorough procedural analysis of ETEC, formalized between Fiocruz and AstraZeneca. Results: Although the National Policy for Technological Innovation in Health (PNITS) describes three viable legal instruments for formalizing partnerships, ETEC was the most adequate to meet the demands imposed by the health emergency of COVID-19, reinforcing the importance of using the State’s purchasing power as an instrument for strengthening the State Health Care System (SUS) within the scope of the Health Industrial Complex. Conclusions: Even  considering the health emergency caused by COVID-19, Bio- Manguinhos/Fiocruz managed to establish a partnership with AstraZeneca, aiming at the TT for the national verticalized production of the COVID-19 vaccine, for the attendance of SUS ́s demand. The legal instrument chosen for the formalization of the partnership was ETEC, the first used in the public health area, which proved feasible to be reproduced in future partnerships aiming at the internalization of technologies of national interest. From the absorption of this technology, Bio-Manguinhos will be able to develop new vaccines of HM’s interest using the same technology.Introdução: A pandemia de COVID-19, provocada pelo SARS-CoV-2, mostrou um rápido aumento do número de casos e mortes nos cinco continentes, com marcante impacto na saúde pública e economia dos países. Os efeitos da COVID-19 evidenciaram um aumento das desigualdades existentes na sociedade. Foi necessária uma mobilização global para o desenvolvimento e produção rápida de vacinas para atender à demanda emergencial causada pelo COVID-19. Objetivo: Discutir as ações realizadas pela Fiocruz nos desafios impostos pela emergência ao combate à doença, além de analisar e discutir a parceria estabelecida entre Bio-Manguinhos/Fiocruz e a AstraZeneca, por meio da Encomenda Tecnológica (ETECT), visando a Transferência de Tecnologia (TT) verticalizada da vacina CHADOX1 NCOV-19. Método: Foi realizada análise documental de natureza descritiva e abordagem qualitativa, realizada a partir da busca de artigos científicos sobre o tema e documentos institucionais, bem como uma análise processual minuciosa da ETEC, formalizada entre a Fiocruz e a AstraZeneca. Resultados: Embora a PNITS descreva três instrumentos jurídicos viáveis para formalização de parcerias, a ETEC foi a mais adequada para atendimento das demandas impostas pela emergência sanitária da COVID-19, reforçando a importância do uso do poder de compra do Estado como instrumento para o fortalecimento do Sistema Único de Saúde (SUS) no âmbito do Complexo Industrial da Saúde. Conclusões: Mesmo considerando a emergência sanitária provocada pela COVID-19, Bio-Manguinhos/Fiocruz conseguiu estabelecer a parceria com a AstraZeneca, visando a TT para produção nacional verticalizada da vacina COVID-19, para atendimento da demanda do SUS. O instrumento jurídico escolhido, para a formalização da parceria, foi a ETEC, a primeira empregada na área da saúde pública, que se mostrou factível de ser reproduzida em futuras parcerias visando a internalização de tecnologias de interesse nacional. A partir da absorção desta tecnologia Bio-Manguinhos poderá desenvolver novas vacinas de interesse do Ministério da Saúde utilizando a mesma tecnologia

Built Heritage Research and Education

The University of Beira Interior (UBI) is one of the most recent Portuguese universities (1986). First polytechnic and then university it is structured in five faculties. The existing knowledge fields include engineering, social sciences, humanities, arts and letters, communication and health sciences. The Department of Civil Engineering and Architecture (DECA) is part of the Faculty of Engineering. The main degrees in the DECA-UBI are the Integrated Master degrees in Architecture and in Civil Engineering. These are a five year program which combines undergraduate and postgraduate study into a single course. The interdisciplinarity and interrelation, which link both research and education, are the basis for the production of knowledge at DECA-UBI. Built heritage is a very important cultural asset as the evidence of any society development and it is a field of interest at DECA-UBI. It refers to all aspects of the man-made environment such as houses, places of worship, commercial and office buildings, monuments and other places of historical significance. Built heritage helps to define a sense of place and identity for communities. It is not only about monuments of exceptional value but also includes small modest vernacular buildings that represent other equally important historical, social and cultural values. The attention paid to the built heritage has increased in Portugal. It should be emphasized that some of these buildings are now used for functions that did not exist when they were built. Furthermore, the actual technical requirements are not always compatible with the former building. A regular maintenance of these buildings may include preservation, rehabilitation, restoration, reconstruction, adaptation and interpretation. Balance needs to be achieved. The future of built heritage conservation is focused on the sustainable built environment. Conservation does not require buildings to be preserved in their original condition to accept contemporary use. It may change over time as community values evolve. However it is important, as a cultural asset, to retain its original heritage features. While heritage conservation is a key player in sustainability planning, interdisciplinary skills that are needed to deliver the heritage studies and projects of the new generation architects which combine aspects of cultural heritage with the best preventive conservation, projects, methodologies and practices. For this purpose it is important to link with engineering sciences. In this paper, the authors describe their experience concerning this link between research and education in the Integrated Master degree in Architecture, which is emphasized by the specific and multidisciplinary research performed as members of the faculty staff at DECA-UBI linking with other sciences of engineering as thermal comfort, acoustics and daylighting. A few examples presented are the analysis of the performance of acoustics and daylight of Cistercians churches, the acoustic analysis as a support for the architectural rehabilitation of an outdated theatre, the thermal performance of new housing of an adapted monastery, to perceive the user’s satisfaction of a vernacular housing through a post occupancy inquiry, the rehabilitation from vernacular ruins.info:eu-repo/semantics/publishedVersio

Genomic structure, promoter activity, and developmental expression of the mouse homologue of the Machado–Joseph disease (MJD) gene

Machado–Joseph disease (MJD) is a neurodegenerative disorder, caused by the expansion of the (CAG)n tract in the MJD gene. This encodes the protein ataxin-3, of unknown function. The mouse Mjd gene has a structure similar to that of its human counterpart and it also contains a TATA-less promoter. Its 5V flanking region contains conserved putative binding regions for transcription factors Sp1, USF, Arnt, Max, E47, and MyoD. Upon differentiation of P19 cells, the Mjd gene promoter is preferentially activated in endodermal and mesodermal derivatives, including cardiac and skeletal myocytes; and less so in neuronal precursors. Mouse ataxin-3 is ubiquitously expressed during embryonic development and in the adult, with strong expression in regions of the CNS affected in MJD. It is particularly abundant in all types of muscle and in ciliated epithelial cells, suggesting that it may be associated with the cytoskeleton and may have an important function in cell structure and/or motility.Fundação Luso-Americana para o Desenvolvimento - (Proc. 3.L./A.II/P.582/99Fundação para a Ciência e a Tecnologia (FCT) - (Project POCTI/MGI 33759/99), BD/9759/ 2003).Fundo Social Europeu (FSE) - Fundo Europeu de Desenvolvimento Regional (FEDER)

Aproximações sobre a realidade dos cursos de ensino superior em Educação Física no Estado do Pará

Approaches on the reality of higher education courses in Physical Education in the State of ParáResumoTrata-se de mapeamento sobre o Ensino Superior no campo da Educação Física no Estado do Pará. A questão problema que baliza este estudo assim se apresenta: qual a realidade dos cursos de Ensino Superior de graduação e pós-graduação em Educação Física no estado do Pará? Metodologicamente, configura-se como uma pesquisa documental e bibliográfica. Apresentamos dados sobre a conjuntura local do Ensino Superior, a quantidade de cursos, o grau e a modalidade de ensino, a quantidade de vagas e inexistência de cursos de pós-graduação. As análises e balanços apontam para algumas implicações da realidade, do debate sobre o estado de conhecimento da Educação Física, dos movimentos do campo de intervenção profissional e das diretrizes curriculares.Palavras-chave: Educação Física e Treinamento. Ensino Superior. Conhecimento. AbstractIt is a question of mapping about Higher Education in the field of Physical Education in the State of Pará. The problem question that this study bears is this: what is the reality of undergraduate and postgraduate courses in Physical Education in the State of For? Methodologically, it is configured as a documentary and bibliographical research. We present data on the local context of Higher Education, the number of courses, the degree and modality of education, the number of vacancies and the lack of postgraduate courses. The analyzes and balances point to some implications of reality, the debate about the state of knowledge of Physical Education, the movements of the field of professional intervention and the curricular guidelines.Keywords: Physical Education and Training. Higher education. Knowledg

A pré-qualificação de medicamentos: análise comparativa entre OMS e Anvisa

The production of medicines with quality, safety and efficacy is essential to meet national and international requirements, aiming at subsidizing pharmaceutical care within the public health. Given the strategic role in which the public health industrial complex is inserted, compliance with Good Manufacturing Practices (GMP) of the World Health Organization (WHO) is essential to export its drugs via international organizations. The objectives of this article were to identify the main technical requirements recommended by WHO and enforced by the Brazilian Health Regulatory Agency (Anvisa), for compliance and recognition of GMP for medicinal products, and to compare them critically, to obtain the prequalification of medicines. This literature and documentary review promoted a comprehensive approach on national regulations and WHO guidelines. This work enabled to show a high degree of harmonization concerning the topics/subtopics compared between WHO and the national standards guides imposed by Anvisa about GMP, which demonstrates an integration of the national legislation in the international context, corroborating the alignment between Anvisa and WHO regarding compliance with GMP.A produção de medicamentos com qualidade, segurança e eficácia é fundamental para atender às demandas nacionais e internacionais, com o fito de subsidiar a assistência farmacêutica no âmbito da saúde pública. Diante do papel estratégico em que o complexo fabril público de saúde está inserido, o cumprimento das Boas Práticas de Fabricação (BPF) da Organização Mundial de Saúde (OMS) é essencial para a exportação de seus medicamentos via organismos internacionais. Os objetivos deste artigo foram identificar os principais requisitos técnicos recomendados pela OMS e exigidos pela Agência Nacional de Vigilância Sanitária (Anvisa), para o cumprimento e reconhecimento das BPF de medicamentos, e compará-los, de maneira crítica, em prol da obtenção da pré-qualificação de medicamentos. A metodologia empregada promoveu uma abordagem abrangente acerca das regulamentações nacionais e dos guias da OMS, por intermédio da seguinte técnica de coleta de dados: pesquisa bibliográfica e documental. O presente trabalho possibilitou evidenciar um alto grau de harmonização acerca dos tópicos/subtópicos comparados entre os guias da OMS e a normatização nacional imposta pela Anvisa em BPF, o que demonstra uma inserção da legislação nacional no contexto internacional, corroborando o alinhamento entre a Anvisa e OMS, no tocante ao cumprimento das BPF

An In Silico Study of the Antioxidant Ability for Two Caffeine Analogs Using Molecular Docking and Quantum Chemical Methods

The antioxidant activity of molecules constitutes an important factor for the regulation of redox homeostasis and reduction of the oxidative stress. Cells affected by oxidative stress can undergo genetic alteration, causing structural changes and promoting the onset of chronic diseases, such as cancer. We have performed an in silico study to evaluate the antioxidant potential of two molecules of the zinc database: ZINC08706191 (Z91) and ZINC08992920 (Z20). Molecular docking, quantum chemical calculations (HF/6-31G**) and Pearson’s correlation have been performed. Molecular docking results of Z91 and Z20 showed both the lower binding affinity (BA) and inhibition constant (Ki) values for the receptor-ligand interactions in the three tested enzymes (cytochrome P450—CP450, myeloperoxidase—MP and NADPH oxidase—NO) than the control molecules (5-fluorouracil—FLU, melatonin—MEL and dextromethorphan—DEX, for each receptor respectively). Molecular descriptors were correlated with Ki and strong correlations were observed for the CP450, MP and NO receptors. These and other results attest the significant antioxidant ability of Z91 and Z20, that may be indicated for further analyses in relation to the control of oxidative stress and as possible antioxidant agents to be used in the pharmaceutical industry

Bioprospecting for microorganisms of biotechnological importance in soils contaminated with agrochemicals

The aim of the present study was to isolate microorganisms from soils contaminated with agrochemicals and to evaluate their potential for biodegradation and production of bioactive metabolites. For this, microorganisms were isolated from a soil sample by the serial dilution technique using four different media: potato dextrose agar (PDA), Mueller Hinton agar (MH), malt extract agar (MEA), and Bushnell Haas agar (BH). The isolated microorganisms were identified by their macro and micromorphological characteristics and were tested for their ability to use the DMA 806 BR agrochemical, by the dichlorophenol indophenol (DCPIP) method. Biosurfactant production and antimicrobial activity were evaluated in the selected microorganisms. The emulsifying activity was evaluated by the emulsification index (IE24) technique, while the antimicrobial activity was evaluated through the solid medium assay against pathogens of clinical interest. Among the media tested, MEA yielded the highest number of isolates, as well as a greater diversity of microbial groups, with a predominance of bacteria. Of the selected microorganisms, ten had the ability to use the agrochemical. Of these ten microorganisms, five presented emulsifying activity and two presented the capacity to produce secondary metabolites. Among them, the J5 and B48 strains were distinguished by their emulsifying and antimicrobial activity

Identification of Potential Inhibitors from Pyriproxyfen with Insecticidal Activity by Virtual Screening

Aedes aegypti is the main vector of dengue fever transmission, yellow fever, Zika, and chikungunya in tropical and subtropical regions and it is considered to cause health risks to millions of people in the world. In this study, we search to obtain new molecules with insecticidal potential against Ae. aegypti via virtual screening. Pyriproxyfen was chosen as a template compound to search molecules in the database Zinc_Natural_Stock (ZNSt) with structural similarity using ROCS (rapid overlay of chemical structures) and EON (electrostatic similarity) software, and in the final search, the top 100 were selected. Subsequently, in silico pharmacokinetic and toxicological properties were determined resulting in a total of 14 molecules, and these were submitted to the PASS online server for the prediction of biological insecticide and acetylcholinesterase activities, and only two selected molecules followed for the molecular docking study to evaluate the binding free energy and interaction mode. After these procedures were performed, toxicity risk assessment such as LD50 values in mg/kg and toxicity class using the PROTOX online server, were undertaken. Molecule ZINC00001624 presented potential for inhibition for the acetylcholinesterase enzyme (insect and human) with a binding affinity value of -10.5 and -10.3 kcal/mol, respectively. The interaction with the juvenile hormone was -11.4 kcal/mol for the molecule ZINC00001021. Molecules ZINC00001021 and ZINC00001624 had excellent predictions in all the steps of the study and may be indicated as the most promising molecules resulting from the virtual screening of new insecticidal agents.Federal University of Amapá, Program in Biotechnology and Biodiversity-Network BIONORTE, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES) and Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq) for funding in the publication of this article