955 resultados para Good manufacturing practices
Resumo:
The undisputed, worldwide success of chemotherapy notwithstanding, schistosomiasis continues to defy control efforts in as much rapid reinfection demands repeated treatment, sometimes as often as once a year. There is thus a need for a complementary tool with effect for the longer term, notably a vaccine. International efforts in this direction have been ongoing for several decades but, until the recombinant DNA techniques were introduced, antigen production remained an unsurmountable bottleneck. Although animal experiments have been highly productive and are still much needed, they probably do not reflect the human situation adequately and real progress can not be expected until more is known about human immune responses to schistosome infection. It is well-known that irradiated cercariae consistently produce high levels of protection in experimental animals but, for various reasons, this proof of principle cannot be directly exploited. Research has instead been focussed on the identification and testing of specific schistosome antigens. This work has been quite successful and is already at the stage where clinical trials are called for. Preliminary results from coordinated in vitro laboratory and field epidemiological studies regarding the protective potential of several antigens support the initiation of such trials. A series of meetings, organized earlier this year in Cairo, Egypt, reviewed recent progress, selecteded suitable vaccine candidates and made firm recommendations for future action including pledging support for large-scale production according to good manufacturing practice (GMP) and Phase I trials. Scientists at the American Centers for Disease Control and Prevention (CDC) have drawn up a detailed research plan. The major financial support will come from USAID, Cairo, which has established a scientific advisory group of Egyptian scientists and representatives from current and previous international donors such as WHO, NIAID, the European Union and the Edna McConnell Clark Foundation.
Resumo:
Some of the elements that characterize the globalization of food and agriculture are industrialization and intensification of agriculture and liberalization of agricultural markets, that favours elongation of the food chain and homogenization of food habits (nutrition transition), among other impacts. As a result, the probability of food contamination has increased with the distance and the number of “hands" that may contact the food (critical points); the nutritional quality of food has been reduced because of increased transport and longer periods of time from collection to consumption; and the number of food-related diseases due to changes in eating patterns has increased. In this context, there exist different agencies and regulations intended to ensure food safety at different levels, e.g. at the international level, Codex Alimentarius develops standards and regulations for the marketing of food in a global market. Although governments determine the legal framework, the food industry manages the safety of their products, and thus, develops its own standards for their marketing, such as the Good Agricultural Practices (GAP) programs. The participation of the private sector in the creation of regulatory standards strengthens the free trade of food products, favouring mostly large agribusiness companies. These standards are in most cases unattainable for small producers and food safety regulations are favouring removal of the peasantry and increase concentration and control in the food system by industrial actors. Particularly women, who traditionally have been in charge of the artisanal transformation process, can be more affected by these norms than men. In this project I am analysing the impcact of food safety norms over small farms, based on the case of artisanal production made by women in Spain.
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The availability of induced pluripotent stem cells (iPSCs)has created extraordinary opportunities for modeling andperhaps treating human disease. However, all reprogrammingprotocols used to date involve the use of products of animal origin. Here, we set out to develop a protocol to generate and maintain human iPSC that would be entirelydevoid of xenobiotics. We first developed a xeno-free cellculture media that supported the long-term propagation of human embryonic stem cells (hESCs) to a similar extent as conventional media containing animal origin products or commercially available xeno-free medium. We also derivedprimary cultures of human dermal fibroblasts under strictxeno-free conditions (XF-HFF), and we show that they can be used as both the cell source for iPSC generation as well as autologous feeder cells to support their growth. We also replaced other reagents of animal origin trypsin, gelatin, matrigel) with their recombinant equivalents. Finally, we used vesicular stomatitis virus G-pseudotyped retroviral particles expressing a polycistronic construct encoding Oct4, Sox2, Klf4, and GFP to reprogram XF-HFF cells under xeno-free conditions. A total of 10 xeno-free humaniPSC lines were generated, which could be continuously passaged in xeno-free conditions and aintained characteristics indistinguishable from hESCs, including colonymorphology and growth behavior, expression of pluripotency-associated markers, and pluripotent differentiationability in vitro and in teratoma assays. Overall, the resultspresented here demonstrate that human iPSCs can be generatedand maintained under strict xeno-free conditions and provide a path to good manufacturing practice (GMP) applicability that should facilitate the clinical translation of iPSC-based therapies.
Resumo:
Rhesus macaques (Macaca mulatta) have played a valuable role in the development of human immunodeficiency virus (HIV) vaccine candidates prior to human clinical trials. However, changes and/or improvements in immunogen quality in the good manufacturing practice (GMP) process or changes in adjuvants, schedule, route, dose, or readouts have compromised the direct comparison of T-cell responses between species. Here we report a comparative study in which T-cell responses from humans and macaques to HIV type 1 antigens (Gag, Pol, Nef, and Env) were induced by the same vaccine batches prepared under GMP and administered according to the same schedules in the absence and presence of priming. Priming with DNA (humans and macaques) or alphavirus (macaques) and boosting with NYVAC induced robust and broad antigen-specific responses, with highly similar Env-specific gamma interferon (IFN-gamma) enzyme-linked immunospot assay responses in rhesus monkeys and human volunteers. Persistent cytokine responses of antigen-specific CD4(+) and CD8(+) T cells of the central memory as well as the effector memory phenotype, capable of simultaneously eliciting multiple cytokines (IFN-gamma, interleukin 2, and tumor necrosis factor alpha), were induced. Responses were highly similar in humans and primates, confirming earlier data indicating that priming is essential for inducing robust NYVAC-boosted IFN-gamma T-cell responses. While significant similarities were observed in Env-specific responses in both species, differences were also observed with respect to responses to other HIV antigens. Future studies with other vaccines using identical lots, immunization schedules, and readouts will establish a broader data set of species similarities and differences with which increased confidence in predicting human responses may be achieved.
Resumo:
L’escola bressol és el primer centre educatiu on els infants tenen accés a l’era digital després de l’entorn familiar que és el primer que reben després del seu naixement. Aquests centres educatius també han de donar resposta a la societat digital que hi ha actualment per tal d’aconseguir un desenvolupament integral de l’infant. Per realitzar aquesta integració de les Tecnologies de la Informació i la Comunicació (TIC) al centre és important una bona formació per part dels docents i tenir clar quins són els elements que fan una bona pràctica TIC. En el present treball final de grau s’aprofundeix en les bones pràctiques educatives en l’ús de les TIC i, posteriorment, es realitza una proposta de transferència de les mateixes a una escola de nova creació.
Resumo:
If adequately designed and high quality material and good construction practices are used, portland cement concrete is very durable. This is demonstrated by the oldest pavement in Iowa (second oldest in the U.S.) paved in 1904, which performed well for 70 years without resurfacing. The design thickness is an important factor in both the performance and cost of pavement. The objective of this paper is to provide a 30-year performance evaluation of a pavement constructed to determine the required design thickness for low volume secondary roadways. In 1951 Greene County and the Iowa Highway Research Board of the Iowa Department of Transportation initiated a four-mile (6.4 km) demonstration project to evaluate thicknesses ranging from 4-1/2" (11.4 cm) to 6" (15.2 cm). The project, consisting of 10 research sections, was formed pavement placed on a gravel roadbed with very little preparation except for redistribution of the loose aggregate. Eight sections were non-reinforced except for centerline tie bars and no contraction joints were used. Mesh reinforcing and contraction joints spaced at 29' 7" (9.02 m) intervals were used in two 4-1/2" (11.4 cm) thick sections. The only air entrained section was non-reinforced. The pavement performed well over its 30-year life carrying a light volume of traffic and did not require major maintenance. There was substantial cracking with average slab length varying directly with thickness. The 4-1/2" (11.4 cm) thick non-air entrained, mesh-reinforced pavement with contraction joints has performed the best.
Resumo:
Presentem una caracterització de la distribució espacial de la contaminació per nitrats en els aqüífers de la plana del baix Fluvià. En concret, els valors de concentració més elevats s’han observat a l’aqüífer superficial, on sobrepassen, amb escreix, els límits de potabilitat aconsellats pel RD 1138/1990. L’àrea més afectada ocupa part dels termes municipals de Vilamacolum i Torroella de Fluvià, en els quals hi predominen concentracions que oscil·len entre 50 i 200 mg × L–1. Els focus de contaminació són de tipus puntual i difús. Documentada la presència anormal de nitrats en aquest aqüífer, es planteja el correcte maneig agrícola, en vistes a una doble finalitat: d’una banda, contribuir a la planificació d’unes bones pràctiques agrícoles tenint en compte la relació entre volums de reg i aportacions de nitrogen; d’altra banda, preveure una progressiva recuperació de la qualitat de l’aqüífer, a partir de l’ús de tecnologies que integrin la ubicació d’unes zones favorables on es pugui maximitzar l’extracció del recurs contaminat, i la ubicació d’uns sòls aptes per a l’aplicació d’aquest recurs, amb uns criteris agronòmics coherents.
Resumo:
El examen de una normativa para mejorar la información al consumidor plantea observaciones pragmáticas sobre buenas prácticas textuales. La orden 385/2003 de la Generalitat de Catalunya establece el tamaño mínimo de la letra en contratos para facilitar su legibilidad. La interpretación de esta normativa permite considerar el uso pragmático de la letra pequeña. Y se recoge también el ejemplo publicitario de una empresa energética que paradójicamente utiliza, en la actualidad, como recurso de prestigio la letra pequeña en documentos contractuales. GOOD TEXTUAL PRACTICES AND INTERPRETABILITY OF THE FINE PRINT IN CONTRACTS. The review of legislation to improve consumer information raises pragmatic observations on textual practices. The order 385/2003 of the Autonomous Government of Catalonia (Spain) sets the minimum font size in contracts for readability. The interpretation of these rules allows us to consider the pragmatic use of the fine print. And the paper also includes advertising from an energy company that paradoxically used as a resource for prestige the fine print in contract documents.
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In this paper, we present procedures for the treatment and final disposal of residual solutions containing chromium, in order to evaluate the effectiveness of chemical precipitation of the metal and the potential of the glass encapsulation technique, using broken laboratory glassware. The results demonstrated that pH-values convenient for chemical precipitation are between 10 - 11. With regard to Cr(OH)3 encapsulation, the leaching and solubilization tests allowed to classify the waste as non-dangerous and non-inert. Finally, it is pointed out that the adoption of waste management practices in universities should be encouraged, helping to train professionals skilled in good laboratory practices.
Resumo:
In the context of quality and good laboratory practices, the article recovers some historical data. From a specific Institutional situation (CPQBA/UNICAMP), is presented an experience of establishing and implementing a standard (NIT-DICLA-035) for good laboratory practice according to definitions of the Brazilian authority (INMETRO) responsible for regulating, monitoring, supervising and recognition in this area. The issue aims to focus on studies of pesticide residues in GLP parameters.
Resumo:
Three growing systems of Arabica coffee were evaluated under the energy perspective, in the state of Espírito Santo in Brazil. The systems are conventional cultivation (CC), cultivation with good agricultural practices (CGP) and organic farming (OF). It was made a comparison of the energy flows within these three systems to show sustainable levels of each one based on production average data of several family-farming units. Therefore, we analyzed crop yield, total energy efficiency reverse (TEER), energy efficiency of ripe coffee (EERC) and non-renewable energy efficiency (NREE). OF system had values for TEER, EERC and NREE of 3.3 4.7 and 7.9 respectively. Yet CC showed values of 1.8, 1.9 and 1.6 for TEER, EERC and NREE respectively. Furthermore, CGP presented values for TEER, EERC and NREE of 0.7, 1.3 and 1.4 respectively. The highest yield was observed in CGP, reaching an amount of 1794 kg ha-1(17,455 MJ); however, this system expends more energy than it converts. Thus, over those points, OF is the most sustainable system.
Resumo:
Diplomityön tavoitteena on selvittää rautatiealalla toimivien yritysten turvallisuuden hallinnan nykytilaa ja löytää keinoja sen parantamiseen. Tutkimuksen kannalta olennaisia teemoja ovat turvallisuuskulttuuri, turvallisuusjohtaminen ja turvallisuusvaatimukset. Työ tarkastelee rautatiealalla toimivia Liikenneviraston palveluntuottajayrityksiä ja heidän näkemyksiään turvallisuuden hallinnan nykytilanteesta edellä mainittujen teemojen ja työn teoriatutkimuksen avulla. Työn teoriaosuus esittelee laajasti rautatiealalla vallitsevia sääntöjä, määräyksiä, ohjeita ja standardeja. Näiden vaatimusten lisäksi teoriaosuus esittelee rautatiealan turvallisuusjohtamisjärjestelmää (TJJ), joka jaetaan turvallisuuden hallinnan osa-alueiksi. Näitä osa-alueita käytetään apuna tunnistettaessa rautatiealalla toimivien yritysten kannalta tärkeimmät turvallisuuden hallinnan osa-alueet. Työn empiirisessä osuudessa toteutetaan haastattelututkimus rautatiealalla toimiville yrityksille. Haastattelujen perusteella tunnistetaan turvallisuuden hallinnan kannalta tärkeitä kehittämiskohteita ja toimivia käytäntöjä turvallisuuteen liittyen. Näiden avulla luodaan kuva turvallisuuden nykytilasta, joka esitetään työn turvallisuusteemojen avulla. Työn tuloksena esitetään malli viidestä, rautatiealalla toimivien yritysten näkökulmasta keskeisestä, turvallisuuden hallinnan osa-alueesta. Mallia soveltamalla rautatiealalla toimivat yritykset pystyvät vastaamaan paremmin turvallisuusvaatimuksiin, kehittämään turvallisuustoimintojaan ja lisäämään koko yrityksen tietoisuutta turvallisuudesta rautatieympäristössä.
Resumo:
The objective of this study was to evaluate the hygienic-sanitary conditions of hospital nutrition and dietary services using external and internal auditors. Eleven hospitals were evaluated for their nutrition and dietary services using an evaluation checklist based on food safety requirements in the current legislation. The checklist was applied by an internal auditor (a technical supervisor) and an external auditor (a professional with experience in food services) between August and October 2011. According to the number of items on the evaluation checklist that were considered adequate, the hospital facilities were ranked as excellent, good, regular, bad, or very bad. The results obtained by the auditors were compared. According to these results, it can be said that most of the hospital nutrition and dietary services were rated as good for overall quality by the internal auditor, while the external auditor classified them as Regular. There was a clear difference between the evaluations of the auditors, both in terms of the number of items considered adequate and the overall requirements' average score. It can be concluded that hospital nutrition and dietary services should meet safety requirements in order to provide food. These facilities should have external audits conducted as a way to prevent routine problems from being perpetuated.
Resumo:
Työn aiheena on vaihteen pienoismallin suunnittelu ja toteutus 3d-tulostusta hyväksi käyttäen. Pienoismalli tehdään Moventas Gears Oy:n suunnittelemasta tuuliturbiinin vaihteesta. Vaihteen pienentämisestä johtuen malliin on suunniteltava uudet laakeripesät ja hammaspyörät. 3D-tulostuksen ja pienoismallin pienen koon ansiosta vaihdetta voidaan yksinkertaistaa suuresti ja näin vähentää tulostettavien osien määrää. Lisäksi työssä selvitetään, mitä ongelmia 3D-tulostus tuo valmistukseen ja suunnitteluun. Työn kirjallisessa osassa selvennetään planeettavaihteen toimintaa yleisesti sekä esitellään Exceed Series 3+ vaihdetta. Lisäksi kerrotaan 3D-tulostuksesta, sen periaatteesta, erilaisista tulostusmenetelmistä, tulostinlaitteesta ja mahdollisista ongelmista tulostuksessa. Kokeellinen osa koostuu pienoismallin suunnittelusta ja valmistuksesta. Valmistuksessa olleiden virheiden takia muutama osa jouduttiin tulostamaan uudelleen. Muutamia osia jouduttiin myös hieman jälkikäsittelemään tulostuksen jälkeen, jotta malli saatiin kasattua. Ongelmakohdaksi muodostui tulostimen ohjelmisto ja tulostustiedostot. Tulostusprosessi sujui kuitenkin hyvin. Lopputuloksena saatiin toimiva pienoismalli. 3D-tulostus toimii hyvin monimutkaisten kappaleiden tulostuksessa. Tulostuksen hinta nousi kuitenkin varsin korkeaksi. Tulostuslaitteistosta riippuen tulostuksen voisi mahdollisesti suorittaa myös halvemmallakin.
Resumo:
Pesticides in “PERA” orange samples (N = 57) from São Paulo City, Brazil were assessed and the pesticide intake contribution was estimated for chronic risk assessment. Seventy-six pesticides were evaluated by the gas chromatography multi-residue method, including isomers and metabolites (4.332 determinations). The mean recoveries at the limit of quantification level were in the range of 72-115% and the relative standard deviation for five replicate samples was 1-11%. The limits of detection and quantification ranged from 0.005 to 0.4 mg.kg−1 and from 0.01 to 0.8 mg.kg−1, respectively. Pesticides were found in 42.1% of the samples at levels ranging from 0.06 to 2.9 mg.kg−1. Of the contaminated samples, 3.5% contained residues (bifenthrin and clofentezine) above the maximum residue level and 12.3% contained unauthorized pesticides (azinphos-ethyl, parathion, myclobutanil, profenofos, and fenitrothion). The estimated risk characterization for orange intake by adults and children, respectively, ranged from 0.04 to 6.6% and from 0.1 to 26.5% of the acceptable daily intake. The detection of irregular residues emphasizes the need for better implementation of Good Agriculture Practices and greater control of formulated products. Other pesticides surveyed did not pose a health risk due to consumption.