A utilização de materiais de referência certificados em análise química é requisito importante em sistemas de garantia da qualidade, pois permite que métodos analíticos sejam validados e que seja obtida a rastreabilidade metrológica de resultados. Isso permite que se obtenham resultados válidos e comparáveis entre si, tanto no espaço quanto no tempo. Neste trabalho, foram realizadas todas as etapas para o preparo de um material de referência de mexilhão nacional, desde a coleta até as etapas de processamento tais como liofilização, moagem, envase e esterilização. Foram utilizados princípios internacionalmente aceitos para a avaliação da homogeneidade e da estabilidade do material, utilizando-se as técnicas analíticas de análise por ativação neutrônica instrumental e espectrometria de absorção atômica. Por meio da organização de programa colaborativo, com a participação de laboratórios nacionais e estrangeiros, foi realizada a caracterização química do material de referência de mexilhão, com determinação de elementos que ocorrem na faixa de porcentagem em massa a mg kg-1, no total de 47 elementos, além de alguns radionuclídeos naturalmente presentes no material. Com a aplicação de técnicas estatísticas adequadas, considerou-se que há possibilidade de certificação de 11 desses elementos: As, Ca, Cl, Co, K, Mg, Mn, Na, Se, Th e Zn. Esse estudo pode ser considerado passo importante no desenvolvimento metrológico nacional, pois demonstra que a produção e caracterização de materiais de referência biológicos, de mexilhão em particular, é viável no Brasil, como ferramenta de garantia da qualidade para estudos ambientais e nutricionais realizados no país. / The use of certified reference materials in chemical analysis is an important requirement in quality assurance systems, as it allows the validation of analytical methods and the realization of the metrological traceability of results. Then, it is possible to obtain valid and comparable results not only in space, but also in time. In this study, all the steps for the preparation of a national mussel reference material were attained, from the collection of the bulk material to processing steps such as freeze-drying, grinding, bottling and sterilization. Internationally accepted principles were applied for the homogeneity and stability assessment of the material, using instrumental neutron activation analysis and atomic absorption spectrometry as analytical techniques. By means of a collaborative program with participation of Brazilian and foreign laboratories, the chemical characterization of the material was performed. Element content in the mass percentage to mg kg-1 range was determined for 47 elements and some radionuclides, naturally present in the material. With the application of suitable statistical treatment to the data, it was considered that the content of 11 of those elements may be certified: As, Ca, Cl, Co, K, Mg, Mn, Na, Se, Th and Zn. This study may be considered an important step in the national metrological development, as it shows that the production and characterization of biological reference materials, mussel in particular, is feasible in Brazil, as a tool for quality assurance of environmental and nutritional studies performed in the country.

In der vorliegenden Arbeit wurden fünf typische Sedimentgesteine, zwei Sandsteine („Grès a Meules“, Fontainebleau), eine Kreide und zwei Kalksteine (Tuffeau, Vuillicin) im Hinblick auf ihre Porosität, Mineralbestand und Transporteigenschaften von Flüssigkeiten und Gasen untersucht. Das Ziel der Arbeit bestand zuerst in der Bestimmung von Standardabweichungen Strukturparameters und in der Aufklärung von Zusammenhängen zwischen den verschiedenen Messergebnissen. Mineralzusammensetzung und Transporteigenschaften Mehrere Zusammenhänge mit Hilfe von Wasser- und Quecksilberporosimetrie, Gasadsorption, Computertomographie, Licht- und Elektronmikroskopie, Wasseraufnahme- und Permeabilitätsmessungen, und mit Hilfe von Porenmodellen konnten nachgewiesen werden. Insbesondere wurde der Einfluss von Tonmineralien auf die Porenstruktur, die Permeabilität und die kapillare Wasseraufnahme nachgewiesen. Der Einfluss der Porenstrukturparameter auf die Wasser- und Gastransporteigenschaften wurde am Beispiel ausgewählter Sedimentgesteine ebenfalls nachgewiesen. Auf der Basis der experimentellen Ergebnisse wurden für die einzelnen Sedimentgesteine typische Porenmodelle entwickelt, die den Zusammenhang zwischen Porenstruktur im weitesten Sinne und den Transporteigenschaften bezüglich Wasser und Gasen wiedergeben. Ein wichtiger Aspekt der Arbeit war die Fragestellung, ob ausgewählte Sedimentgesteine als Referenz- bzw. Standardmaterialien für die Bewertung von Messverfahren oder von anderen Geomaterialien dienen können. Dazu wurden umfassende Homogenitätsuntersuchungen durchgeführt. Es zeigte sich, dass eine Gesteinsart (Vuillecin-Kalkstein) unabhängig von der Probengröße inhomogen war und daher in keinem Falle als Geo-Standard in Betracht kommen kann. Bei den anderen hier untersuchten Sedimentgesteinen wurde gefunden, dass sie für Messverfahren, die ein relativ großes Probenvolumen (> 15 cm3) benötigen (z. B. die Wasserporosimetrie oder die Kapillaraufstiegsmethode an Bohrkernen) als hinreichend homogen bezüglich des Einsatzes als mögliche Geo-Referenzmaterialien einzustufen sind. Damit könnten sie u. a. zur Entwicklung oder Überprüfung z. B. von Modellen für Transporteigenschaften von Geomaterialien oder als Untersuchungsmaterial für Ringversuche verwendet werden. Im Falle von Messverfahren, die ein kleineres Probenvolumen (weniger als 2 oder 3 cm3) voraussetzen, beispielsweise die Gasadsorption oder die Quecksilberporosimetrie, war die gefundene Homogenität aller fünf hier untersuchten Sedimentgesteine nicht mehr ausreichend, um als Kandidatenmaterial für eine Referenzmaterial-Zertifizierung zu dienen. Dies spiegelte sich deutlich in den wesentlich größeren Streuungen der Messresultate gegenüber "synthetischen" zertifizierten Referenzmaterialien für die Gasadsorption und die Hg-Porosimetrie wieder. Damit entfällt auch ein möglicher Einsatz für die Kalibrierung von Messapparaturen oder für Methodenvalidierungen. / In this study, five typical sedimentary rocks, two sandstones (Fontainebleau, “Grès à Meules”), a chalk and two limestones (tuffeau, Vuillecin) were analyzed with regards to their porous structure, mineral structure and fluid transport properties. The aim of this study was first to assess the different characteristics of the rocks regarding their variations and their inter-dependences. Relationships were established using techniques such as water and mercury porosimetry, gas adsorption, X-ray computed tomography, optical and electron microscopy, and performing gas permeability and water imbibition measurements and pore model analyses. In particular, the role of clay mineral concentrations was exposed and the porous structure parameters, on which the fluid transport properties significantly depend, were identified regarding the degree of their influence. Furthermore, new ideal pore models were schematized. These models describe the fluid transport behaviours of the rocks either for gas flow or water imbibition. The second main goal was to express if or not these geomaterials could become useful reference materials or standards. It was shown that the degrees of homogeneity of the rocks were low in comparison with any existing certified reference materials, which are industrially synthesized. For this major reason, the possibilities of the elaboration of useful reference values using the rocks were found to be restraint. For instance, it was evident that the Vuillecin limestone had a too low homogeneity degree to be reasonably used in any way as reference material. The variations of many structure parameters of the other rocks were low for big samples (over 15 cm³). In this case, standards could be elaborated using methods such as the water porosimetry or the capillary water imbibition kinetics. Such standards would be useful in the field of geomaterial research for qualitative inter-comparisons and for the control or the development of pore models applied to the analysis of fluid transport properties. For small sample volumes (generally below 2 or 3 cm³) measured using techniques such as mercury porosimetry or gas adsorption, the accuracy of the structure parameters was too low and the rocks were found to be unsuitable for elaborating reference or standard values in the aim of the calibrating instruments, testing the efficiency of apparatus or validating new methods.

O Brasil é um dos grandes produtores mundiais de minério de ferro e exporta a maior parte da sua produção. No comércio internacional é importante assegurar a comparabilidade dos resultados analíticos obtidos em diferentes laboratórios. Uma variação de 0,1 % na média do teor de ferro pode aumentar ou diminuir em muito o valor de um grande carregamento de minério. Assim, os sistemas de garantia da qualidade dos laboratórios necessitam de materiais de referência. Este trabalho estudou a preparação de um lote de minério de ferro (pelotizado) como material de referência, certificando os teores de vários constituintes por meio de um programa interlaboratorial. Treze laboratórios participaram do programa e dezoito componentes do minério tiveram seus teores certificados: Fetotal (65,1%), SiO2 (2,76%), Al2O3 (0,46%), TiO2 (0,056%), P (0,026%), S (0,003%), MnO (0,094%), CaO (3,31%), MgO (0,043%), K2O (0,013%), Ba (0,004%), Zn (13 mg/kg), Cu (10 mg/kg), Co (12 mg/kg), Cr (56 mg/kg), Pb (15 mg/kg), Ni (14 mg/kg), V (48 mg/kg). / Brazil is one of the great worldwide iron ore producers and exports most of its production. In the international trade it is important to make sure the comparison of the analytical results among different laboratories. A variation of 0,1% in the average of the iron content can increase or decrease the value of a large ore shipment. Thus, the quality guarantee systems of the laboratories need certified reference materials. The aim of this work was the preparation an amount of iron ore (pellets) as reference material, being certified content of some constituents through an interlaboratory program. Thirteen laboratories participated of the program and eighteen components of the ore had its content certified: Fetotal (65,1%), SiO2 (2,76%), Al2O3 (0,46%), TiO2 (0,056%), P (0,026%), S (0,003%), MnO (0,094%), CaO (3,31%), MgO (0,043%), K2O (0,013%), Ba (0,004%), Zn (13 mg/kg), Cu (10 mg/kg), Co (12 mg/kg), Cr (56 mg/kg), Pb (15 mg/kg), Ni (14 mg/kg), V (48 mg/kg).

A utilização de materiais de referência certificados em análise química é requisito importante em sistemas de garantia da qualidade, pois permite que métodos analíticos sejam validados e que seja obtida a rastreabilidade metrológica de resultados. Isso permite que se obtenham resultados válidos e comparáveis entre si, tanto no espaço quanto no tempo. Neste trabalho, foram realizadas todas as etapas para o preparo de um material de referência de mexilhão nacional, desde a coleta até as etapas de processamento tais como liofilização, moagem, envase e esterilização. Foram utilizados princípios internacionalmente aceitos para a avaliação da homogeneidade e da estabilidade do material, utilizando-se as técnicas analíticas de análise por ativação neutrônica instrumental e espectrometria de absorção atômica. Por meio da organização de programa colaborativo, com a participação de laboratórios nacionais e estrangeiros, foi realizada a caracterização química do material de referência de mexilhão, com determinação de elementos que ocorrem na faixa de porcentagem em massa a mg kg-1, no total de 47 elementos, além de alguns radionuclídeos naturalmente presentes no material. Com a aplicação de técnicas estatísticas adequadas, considerou-se que há possibilidade de certificação de 11 desses elementos: As, Ca, Cl, Co, K, Mg, Mn, Na, Se, Th e Zn. Esse estudo pode ser considerado passo importante no desenvolvimento metrológico nacional, pois demonstra que a produção e caracterização de materiais de referência biológicos, de mexilhão em particular, é viável no Brasil, como ferramenta de garantia da qualidade para estudos ambientais e nutricionais realizados no país. / The use of certified reference materials in chemical analysis is an important requirement in quality assurance systems, as it allows the validation of analytical methods and the realization of the metrological traceability of results. Then, it is possible to obtain valid and comparable results not only in space, but also in time. In this study, all the steps for the preparation of a national mussel reference material were attained, from the collection of the bulk material to processing steps such as freeze-drying, grinding, bottling and sterilization. Internationally accepted principles were applied for the homogeneity and stability assessment of the material, using instrumental neutron activation analysis and atomic absorption spectrometry as analytical techniques. By means of a collaborative program with participation of Brazilian and foreign laboratories, the chemical characterization of the material was performed. Element content in the mass percentage to mg kg-1 range was determined for 47 elements and some radionuclides, naturally present in the material. With the application of suitable statistical treatment to the data, it was considered that the content of 11 of those elements may be certified: As, Ca, Cl, Co, K, Mg, Mn, Na, Se, Th and Zn. This study may be considered an important step in the national metrological development, as it shows that the production and characterization of biological reference materials, mussel in particular, is feasible in Brazil, as a tool for quality assurance of environmental and nutritional studies performed in the country.

A participação de laboratórios nacionais em ensaios de proficiência internacionais expõe a fragilidade técnica na produção de Materiais de Referência (MR) no Brasil, devido à insuficiência desse tipo de material, tanto para ensaio de proficiência quanto para a rotina laboratorial. A capacitação de um Laboratório Central de Saúde Pública (LACEN) como produtor de MR, em bioquímica laboratorial, permitirá a disponibilização para toda rede de laboratórios públicos do estado de São Paulo, contribuindo na melhoria da qualidade das análises laboratoriais em bioquímica. A Secretaria de Estado da Saúde (SES) poderá padronizar a qualidade desses exames em toda rede pública estadual, detendo a tecnologia necessária para o controle de qualidade. O objetivo desse estudo foi mostrar a viabilidade de produção de MR candidatos à certificação para os perfis: lipídico, renal, hepático, glicêmico, cardíaco e ósseo e a utilização como controle de qualidade em laboratórios clínicos de bioquímica. A produção foi feita a partir de soro de origem animal, estabilizado e liofilizado, com caráter específico para dosagens bioquímicas, seja em metodologia manual, semi-automatizada ou automatizada. Para a análise quantitativa dos dados foi utilizado o aplicativo Action Act versão 8.2.1. O modelo possibilitará o uso para desenvolvimento de outros programas de ensaio de proficiência. A implementação resultará em um ganho de qualidade a baixo custo e incentivo para a implantação de sistemas de qualidade que garantam a confiabilidade dos exames laboratoriais da rede de laboratórios públicos estadual / The participation of national laboratories in International Proficiency Testing demonstrates the technical weakness in the production of Reference Materials (RM) in Brazil, due to the failure of this type of material for use both as proficiency testing for the routine laboratory. It is vital to encourage training providers to produce reference materials control serum, high quality and low cost in clinical biochemistry and encourage the implementation of quality systems to ensure the reliability of clinical laboratory. Accreditation biochemical testing and qualification of a Central Public Health Laboratory (LACEN) as a producer of Reference Materials for proficiency testing in clinical biochemistry allow it to be available for the entire network of public laboratories in the State of São Paulo, contributing to improving the quality of laboratory analyzes biochemical processes for measurands and accredited. The State may standardize the quality of clinical examinations in all public schools, holding the technology needed to quality control. The aim of this study is to show the viability of producing candidates for certification for the profiles: renal, hepatic, lipid, glucose, cardiac and bone and the use in biochemistry laboratories. The reference material in biochemistry will be produced from biological material of animal origin, stabilized and lyophilized serum with specific character to be used in biochemical, whether in methodology manual, semi-automated or automated. For the quantitative analysis of the data the Action Act version 8.2.1 application was used. The implementation will result in a gain of quality at low cost and incentive for the implementation of quality systems to ensure the reliability of laboratory tests of state public health laboratories network

This thesis describes the in vitro production of drug metabolites using fungi of the Cunninghamella species. The metabolites were characterized with mainly liquid chromatography-mass spectrometry using ion-trap and quadrupole-time-of-flight instruments. A fungal in vitro model has several advantages e.g., it is easily up-scaled and ethical problems associated with animal-based models are avoided. The metabolism of bupivacaine and the selective androgen receptor modulators (SARMs) S1, S4 and S24 by the fungi Cunninghamella elegans and Cunninghamella blakesleeana was investigated. The detected metabolites were compared with those formed in vitro and in vivo by human and horse and most phase I metabolites formed by mammals were also formed by the fungi. The higher levels of bupivacaine metabolites in the fungal samples allowed an extensive mass spectrometric structural characterization which shows that the fungi are relevant metabolic models. Glucuronides are important drug metabolites but they are difficult to synthesize. The discovery that the fungus Cunninghamella elegans formed large amounts of glucosides led to the idea that they could be used to form glucuronides. A new concept was developed where a fungal incubate containing a SARM S1 glucoside was mixed with the free radical tetramethylpiperidinyl-1-oxy (TEMPO), sodium bromide and sodium hypochlorite which produced a glucuronide. Isolation and characterization by nuclear magnetic resonance spectroscopy proved that the new method could produce glucuronides for use as reference material. An investigation of reactive metabolite formation of the drugs paracetamol, mefenamic acid and diclofenac by the fungus Cunninghamella elegans was performed. It was demonstrated for the first time that the fungus could produce glutathione, glutathione ethyl-ester, cysteine and N-acetylcysteine conjugates that are indicative of a preceding formation of reactive intermediates. A comparison with conjugates formed by human liver microsomes showed that both models formed identical metabolites. The presented investigations prove that Cunninghamella fungi are relevant drug metabolism models. They show that the fungi to a large extent forms the same metabolites as mammals and that they can produce metabolites for use as reference material in, e.g. doping control. It was also demonstrated that the fungal model can be used in the important assessment of drug toxicity.

Submitted by Alexandre Sousa (alexandre.sousa@incqs.fiocruz.br) on 2015-04-07T11:49:38Z No. of bitstreams: 1 Dissertação_Danielle_Almeida.pdf: 2650975 bytes, checksum: 80a18514ce2bd91e7361e6eacc16a783 (MD5) / Approved for entry into archive by Alexandre Sousa (alexandre.sousa@incqs.fiocruz.br) on 2015-04-07T11:49:55Z (GMT) No. of bitstreams: 1 Dissertação_Danielle_Almeida.pdf: 2650975 bytes, checksum: 80a18514ce2bd91e7361e6eacc16a783 (MD5) / Approved for entry into archive by Alexandre Sousa (alexandre.sousa@incqs.fiocruz.br) on 2015-04-07T11:50:12Z (GMT) No. of bitstreams: 1 Dissertação_Danielle_Almeida.pdf: 2650975 bytes, checksum: 80a18514ce2bd91e7361e6eacc16a783 (MD5) / Made available in DSpace on 2015-04-07T11:50:12Z (GMT). No. of bitstreams: 1 Dissertação_Danielle_Almeida.pdf: 2650975 bytes, checksum: 80a18514ce2bd91e7361e6eacc16a783 (MD5) Previous issue date: 2014 / Fundação Oswaldo Cruz. Instituto Nacional de Controle de Qualidade em Saúde / Vacinas são os únicos meios para interromper a cadeia de transmissão de doenças imunopreviníveis. A vacina tríplice viral (contra sarampo, caxumba e rubéola), fornecida por Bio-Manguinhos, é constituída da mistura dos vírus vivos atenuados do sarampo, caxumba e rubéola. É de grande importância o efetivo controle da qualidade deste produto antes do seu ingresso no mercado, sendo necessária a realização do ensaio de potência biológica com a utilização de uma vacina de referência. O presente estudo teve como objetivo principal avaliar um lote vacinal como material de referência de trabalho (MRT) candidato (cMRTBio) para ser utilizado na rotina da determinação de potência da vacina tríplice viral em substituição a vacina disponibilizada pela GlaxoSmithKline (GSK) empregada anteriormente.Este estudo foi baseado nas normativas de compêndios que preconizam os estudos de caracterização do lote candidato quanto à homogeneidade e estabilidade, utilizando-se ferramentas estatísticas adequadas,visando à atribuição do seu valor, atendendo aos propósitos desejados e agregando maior confiabilidade aos ensaios de potência realizados pelo laboratório. O lote designado de 131VVA002Z utilizado como cMRTBio apresentou características como integridade, composição e potência em conformidade com as especificações exigidas. No estudo de homogeneidade, os resultados obtidos foram considerados homogêneos intra-frascos e inter-frascos, já que todos os coeficientes de variação obtidos foram inferiores a 10%, estando dentro do limite de aceitação. A potência estimada de cada componente viral do cMRTBio foi de: 3,73 log10 CCID50 / DH para o vírus do sarampo, 4,75 log10 CCID50 / DH para o vírus da caxumba e 3,67 (log10 CCID50 / DH) para o vírus rubéola, estando dentro das especificações previstas. No estudo de estabilidade verificamos um pequeno decaimento de potência, sendo estes valores considerados irrelevantes, uma vez que a potência encontrada ainda se encontrava dentro dos valores determinados para a especificação da vacina. De acordo com os resultados obtidos, verificamos que o cMRTBio apresentou todas as características exigidas para ser utilizado como MRT, sendo este material protocolado na Instituição como MRT(B)TVV001/13. / Vaccines are the only means to interrupt the transmission chain of transmission of immune predictable diseases. The MMR vaccine (measles, mumps and rubella), supplied by Bio-Manguinhos, is composed of a mixture of live attenuated viruses of measles, mumps and rubella. It is of great importance to the effective control of the quality of this product before its market entrance because it is necessary to perform the test of biological power with the use of a reference vaccine. The main objective of this study was to evaluate a batch vaccine as work reference material (MRT) candidate (cMRTBio) to be used in the routine determination of power of the MMR vaccine in replacing the vaccine made by GlaxoSmithKline (GSK), which was previously employed. This study was based on normative compendia that advocate the studies of characterization of candidate batch homogeneity and stability, using appropriate statistical tools, aiming the allocation of its value, taking into account the purposes intended and aggregating greater reliability to tests of power performed by the laboratory. The batch designated as 131AWV002Z used as cMRTBio presented characteristics such as integrity, composition and power in accordance with the required specifications. In the homogeneity study, the results obtained were considered homogeneous intra-bottles and inter-bottles, considering that all coefficients of variation obtained were lower than 10 %, while within the limit of acceptance. The estimated power of each viral component of cMRTBio was: 3.73 log10 CCID50 / DH for the measles virus, 4.75 log10 CCID50 / DH for the mumps virus and 3.67 (log10 CCID50 / DH) for the rubella virus, being within the specifications provided. In the study of stability we noticed a small decay of power, being these values considered irrelevant, since the power found was still within the values determined for the specification of the vaccine. According to the results obtained, we can notice that the cMRTBio presented all the required characteristics to be used as MRT, being this material filed in the Institution as MRT(B)TVV001/13.

O Brasil é um dos grandes produtores mundiais de minério de ferro e exporta a maior parte da sua produção. No comércio internacional é importante assegurar a comparabilidade dos resultados analíticos obtidos em diferentes laboratórios. Uma variação de 0,1 % na média do teor de ferro pode aumentar ou diminuir em muito o valor de um grande carregamento de minério. Assim, os sistemas de garantia da qualidade dos laboratórios necessitam de materiais de referência. Este trabalho estudou a preparação de um lote de minério de ferro (pelotizado) como material de referência, certificando os teores de vários constituintes por meio de um programa interlaboratorial. Treze laboratórios participaram do programa e dezoito componentes do minério tiveram seus teores certificados: Fetotal (65,1%), SiO2 (2,76%), Al2O3 (0,46%), TiO2 (0,056%), P (0,026%), S (0,003%), MnO (0,094%), CaO (3,31%), MgO (0,043%), K2O (0,013%), Ba (0,004%), Zn (13 mg/kg), Cu (10 mg/kg), Co (12 mg/kg), Cr (56 mg/kg), Pb (15 mg/kg), Ni (14 mg/kg), V (48 mg/kg). / Brazil is one of the great worldwide iron ore producers and exports most of its production. In the international trade it is important to make sure the comparison of the analytical results among different laboratories. A variation of 0,1% in the average of the iron content can increase or decrease the value of a large ore shipment. Thus, the quality guarantee systems of the laboratories need certified reference materials. The aim of this work was the preparation an amount of iron ore (pellets) as reference material, being certified content of some constituents through an interlaboratory program. Thirteen laboratories participated of the program and eighteen components of the ore had its content certified: Fetotal (65,1%), SiO2 (2,76%), Al2O3 (0,46%), TiO2 (0,056%), P (0,026%), S (0,003%), MnO (0,094%), CaO (3,31%), MgO (0,043%), K2O (0,013%), Ba (0,004%), Zn (13 mg/kg), Cu (10 mg/kg), Co (12 mg/kg), Cr (56 mg/kg), Pb (15 mg/kg), Ni (14 mg/kg), V (48 mg/kg).

A participação de laboratórios nacionais em ensaios de proficiência internacionais expõe a fragilidade técnica na produção de Materiais de Referência (MR) no Brasil, devido à insuficiência desse tipo de material, tanto para ensaio de proficiência quanto para a rotina laboratorial. A capacitação de um Laboratório Central de Saúde Pública (LACEN) como produtor de MR, em bioquímica laboratorial, permitirá a disponibilização para toda rede de laboratórios públicos do estado de São Paulo, contribuindo na melhoria da qualidade das análises laboratoriais em bioquímica. A Secretaria de Estado da Saúde (SES) poderá padronizar a qualidade desses exames em toda rede pública estadual, detendo a tecnologia necessária para o controle de qualidade. O objetivo desse estudo foi mostrar a viabilidade de produção de MR candidatos à certificação para os perfis: lipídico, renal, hepático, glicêmico, cardíaco e ósseo e a utilização como controle de qualidade em laboratórios clínicos de bioquímica. A produção foi feita a partir de soro de origem animal, estabilizado e liofilizado, com caráter específico para dosagens bioquímicas, seja em metodologia manual, semi-automatizada ou automatizada. Para a análise quantitativa dos dados foi utilizado o aplicativo Action Act versão 8.2.1. O modelo possibilitará o uso para desenvolvimento de outros programas de ensaio de proficiência. A implementação resultará em um ganho de qualidade a baixo custo e incentivo para a implantação de sistemas de qualidade que garantam a confiabilidade dos exames laboratoriais da rede de laboratórios públicos estadual / The participation of national laboratories in International Proficiency Testing demonstrates the technical weakness in the production of Reference Materials (RM) in Brazil, due to the failure of this type of material for use both as proficiency testing for the routine laboratory. It is vital to encourage training providers to produce reference materials control serum, high quality and low cost in clinical biochemistry and encourage the implementation of quality systems to ensure the reliability of clinical laboratory. Accreditation biochemical testing and qualification of a Central Public Health Laboratory (LACEN) as a producer of Reference Materials for proficiency testing in clinical biochemistry allow it to be available for the entire network of public laboratories in the State of São Paulo, contributing to improving the quality of laboratory analyzes biochemical processes for measurands and accredited. The State may standardize the quality of clinical examinations in all public schools, holding the technology needed to quality control. The aim of this study is to show the viability of producing candidates for certification for the profiles: renal, hepatic, lipid, glucose, cardiac and bone and the use in biochemistry laboratories. The reference material in biochemistry will be produced from biological material of animal origin, stabilized and lyophilized serum with specific character to be used in biochemical, whether in methodology manual, semi-automated or automated. For the quantitative analysis of the data the Action Act version 8.2.1 application was used. The implementation will result in a gain of quality at low cost and incentive for the implementation of quality systems to ensure the reliability of laboratory tests of state public health laboratories network

L’objectif principal du présent mémoire est d’observer le processus de traduction d’un texte de nature juridique mis en oeuvre par deux groupes d’étudiants, cinq étudiants inscrits au baccalauréat en traduction et quatre inscrits au baccalauréat en droit. Tout d’abord, nous analyserons les différences qui existent entre les deux groupes dans leur utilisation des ouvrages de référence. Nous observerons entre autres la diversité générale des ouvrages consultés et la connaissance antérieure des ouvrages papier, la répartition par type d’ouvrages (dictionnaire bilingue, monolingue ou autres), la répartition par support d’ouvrages (électronique ou papier), l’utilisation des correcteurs, l’intensité des recherches effectuées et, finalement, le premier ouvrage consulté selon le type et le support. Ces données seront recueillies grâce à la méthode de verbalisation à voix haute et à l’enregistrement de l’écran d’ordinateur, au moyen du logiciel WebEx. Ensuite, nous évaluerons la qualité des traductions en faisant une distinction entre deux types d’erreurs, soit les erreurs de traduction et les erreurs de langue. Nous tenterons par la suite d’établir des liens entre l’utilisation des ouvrages de référence et la qualité des traductions. Nous observerons que les deux groupes utilisent les ouvrages de référence différemment et que les traducteurs ont semblé mieux outillés que les juristes pour remettre une traduction de qualité. / The main goal of this paper is to observe the translation process of a legal text translated by two groups of students: five undergraduate students in translation, and four in the LLB. First, we analyze the differences between the two groups in their use of reference material. Among other aspects, we observe the overall diversity of reference material consulted and previous knowledge of paper reference material, its use by type (bilingual dictionary, monolingual or others), by media (electronic or paper), the use of spellcheckers, the intensity of research and, finally, the first reference material consulted by type and support. These data were collected by using the think-aloud method and by recording the computer screen with a screen recording software: WebEx. Then, we evaluate the quality of the translations by distinguishing between two types of errors, translation errors and language errors. We then try to establish links between the use of reference material and translation quality. We observed that the two groups used reference material differently and that the translators seemed better equipped than the lawyers to deliver a better translation.