932 resultados para Good manufacturing practice
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ABSTRACT: Apprenticeship is a period of increased risk of developing work-related respiratory allergic diseases. There is a need for documents to provide appropriate professional advice to young adults aiming to reduce unsuitable job choices and prevent impairment from their careers. The present document is the result of a consensus reached by a panel of experts from European and non-European countries addressed to allergologists, pneumologists, occupational physicians, primary care physicians, and other specialists interested in this field, which aims to reduce work-related respiratory allergies (rhinoconjunctivitis and asthma) among allergic or nonallergic apprentices and other young adults entering the workforce. The main objective of the document is to issue consensus suggestions for good clinical practice based on existing scientific evidence and the expertise of a panel of physicians.
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La qualitat de vida s’està convertint en un concepte clau i unificador en l’atenció i educació de les persones amb discapacitat intel•lectual. Així mateix, la percepció actual sobre les persones amb discapacitat ha canviat substancialment. En el moment actual, cal plantejar-se quines són les aplicacions i les implicacions que tenen per l’atenció i educació de les persones amb discapacitat intel•lectual els principis derivats del nou concepte de discapacitat i de la qualitat de vida. Aquesta investigació pretén essencialment elaborar un conjunt d’instruments que permetin avaluar la qualitat de les pràctiques educatives dels centres d’educació especial. Amb aquest objectiu s’ha seguit un procediment estructurat i ordenat en l’elaboració dels instruments com en la seva valoració inicial. Per avaluar la qualitat dels centres d’educació especial es proposen una sèrie qüestionaris tant pels professionals, les famílies i els alumnes. Els resultats indiquen que el conjunt d’instruments d’avaluació permeten recollir informació àmplia i variada de les pràctiques d’un centre d’educació especial, determinar les seves fortaleses i debilitats i servir de base per establir plans de millora estretament relacionats amb el context particular del centre i amb el que es considera una bona pràctica educativa.
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This third and final report of the CEMACH national diabetes programme comes at an important time in the national drive to improve services for women with diabetes in pregnancy. The National Service Framework (NSF) for Diabetes requires the NHS to develop, implement and monitor policies that seek to empower and support women with diabetes to optimise the outcomes of their pregnancy. The CEMACH report shows that, whilst progress has been made in improving services for women with diabetes and their babies, there is much still to be done to meet the standards recommended by the NSF. Too many women continue to be poorly prepared for pregnancy in the critical areas of glycaemic control and folic acid supplementation. The report underlines the need for an increased focus on diabetes preconception care services and the development of strategies to educate women with diabetes of childbearing age. The growing proportion of women with type 2 diabetes during pregnancy, many of whom are from minority ethnic groups, presents an additional challenge for health services in developing responsive and accessible services.This CEMACH report has identifi ed several areas of good clinical practice during pregnancy in women with pre-existing diabetes. However, there continue to be areas where there is room for improvement, including antenatal fetal surveillance, glycaemic control during labour and delivery and postnatal diabetes care. The National Institute for Health and Clinical Excellence (NICE) is currently in the fi nal stages of development of its new guideline for the management of diabetes in pregnancy. This guideline, when taken together with the CEMACH report, will provide local health services with an unprecedented wealth of material on which to base their development of improved services for women with diabetes in pregnancy.��
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Transcatheter (or percutaneous) renal denervation is a novel technique developed for the treatment of resistant hypertension. So far, only one randomised controlled trial has been published, which has shown a reduction of office blood pressure. The Swiss Society of Hypertension, the Swiss Society of Cardiology, The Swiss Society of Angiology and the Swiss Society of Interventional Radiology decided to establish recommendations to practicing physicians and specialists for good clinical practice. The eligibility of patients for transcatheter renal denervation needs (1.) confirmation of truly resistant hypertension, (2.) exclusion of secondary forms of hypertension, (3.) a multidisciplinary decision confirming the eligibility, (4.) facilities that guarantee procedural safety and (5.) a long-term follow-up of the patients, if possible in cooperation with a hypertension specialist. These steps are essential until long-term data on safety and efficacy are available.
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En la asignatura de Farmacia Galénica III y Gestión de Calidad se ha llevado a cabo una actividad de campo en el curso 2011/2012, que consistía en una visita a 4 labo-ratorios farmacéuticos autorizados (Kern Pharma, Almirall, Reig Jofré y Novartis) para ver evidencias de cumplimientos de las NCF o GMP (Normas de Correcta Fa-bricación o Good Manufacturing Practices) en el entorno profesional y real.El objetivo del estudio es evaluar la capacidad analítica de los estudiantes de 4º cur-so de farmacia en cuanto a cumplimiento de las NCF. Para el desarrollo de la activi-dad se han organizado los estudiantes en diferentes grupos con la finalidad de “auditar”. La actividad implicaba preparar un cuestionario previo, realizar la visita y elaborar el informe final. Los resultados obtenidos han sido que aproximadamente un 97,1% de los alumnos han superado esta actividad con una nota media de 8,23. Se constata que la realización de esta actividad por parte de los estudiantes comporta una mejora de la calificación final de la asignatura respecto al curso previo.
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Aquest projecte s’emmarca dins els sistemes de sanejament i forma part del projecte GEISTTAR finançat pel Ministerio de Economía y Competitividad (MINECO) (CTM2011-27163) liderat per la investigadora Maite Pijuan, el qual te l’objectiu d’estudiar la formació de gasos d’efecte hivernacle que es produeixen en Estacions Depuradores d’Aigües Residuals (EDARs), concretament en el reactor biològic. Una tasca dins el projecte, liderada per l’investigador Lluís Corominas, és la modelització de processos biològics en l’EDAR de Granollers per ajudar a entendre els mecanismes de degradació de matèria orgànica i nitrogen. Aquest treball estableix les bases per poder realitzar aquesta modelització en estat estacionari, seguint els passos proposats pel Good Modelling Practice (GMP) Task Group de la IWA. Els objectius específics que es proposen són l’anàlisi i estudi dels resultats del test de traçadors realitzat per l’Institut Català de Recerca de l’Aigua (ICRA) i realitzar una bona recopilació de dades sobre l’EDAR de Granollers per facilitar els estudis posteriors a aquest projecte.
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Tutkimuksen tarkoitus on selvittää millaista tilintarkastuksen odotuskuilu on, mitkä syyt siihen johtavat ja miten odotuskuilua voidaan kaventaa. Aluksi käydään läpi tilintarkastusta, hyvää tilintarkastustapaa, mitä lakisääteiseen tilintarkastukseen sekä konsultointiin kuuluu ja mitä erikoisuuksia pk-yritysten tilintarkastamiseen kuuluu. Sen jälkeen käsitellään tilintarkastuksen odotuskuilua kirjallisuuden ja artikkelien perusteella. Tässä käydään tarkemmin läpi mitä tilintarkastuksen odotuskuilu on, mitkä syyt siihen johtavat sekä miten sitä voidaan kaventaa. Tämän jälkeen käydään tutkimuksen empiiristä osiota läpi, jossa auktorisoidut tilintarkastajat ovat vastanneet tilintarkastuksen odotuskuilua koskeviin kysymyksiin. Voidaan sanoa, että tilintarkastuksen odotuskuilu on kuilu yleisön odotuksista tilintarkastuksesta verrattuna siihen, mitä lakisääteinen tilintarkastus itse asiassa on. Odotuskuiluun on monia syitä, muun muassa tilintarkastuksen todennäköinen luonne ja yleisön ylisuuret odotukset. Odotuskuilua voidaan kaventaa kahdella tavalla: valistamalla yleisöä tai muuttamalla tilintarkastuksen luonnetta vastaamaan yleisön odotuksia.
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PRINCIPLES: The literature has described opinion leaders not only as marketing tools of the pharmaceutical industry, but also as educators promoting good clinical practice. This qualitative study addresses the distinction between the opinion-leader-as-marketing-tool and the opinion-leader-as-educator, as it is revealed in the discourses of physicians and experts, focusing on the prescription of antidepressants. We explore the relational dynamic between physicians, opinion leaders and the pharmaceutical industry in an area of French-speaking Switzerland. METHODS: Qualitative content analysis of 24 semistructured interviews with physicians and local experts in psychopharmacology, complemented by direct observation of educational events led by the experts, which were all sponsored by various pharmaceutical companies. RESULTS: Both physicians and experts were critical of the pharmaceutical industry and its use of opinion leaders. Local experts, in contrast, were perceived by the physicians as critical of the industry and, therefore, as a legitimate source of information. Local experts did not consider themselves opinion leaders and argued that they remained intellectually independent from the industry. Field observations confirmed that local experts criticised the industry at continuing medical education events. CONCLUSIONS: Local experts were vocal critics of the industry, which nevertheless sponsor their continuing education. This critical attitude enhanced their credibility in the eyes of the prescribing physicians. We discuss how the experts, despite their critical attitude, might still be beneficial to the industry's interests.
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Drying is a major step in the manufacturing process in pharmaceutical industries, and the selection of dryer and operating conditions are sometimes a bottleneck. In spite of difficulties, the bottlenecks are taken care of with utmost care due to good manufacturing practices (GMP) and industries' image in the global market. The purpose of this work is to research the use of existing knowledge for the selection of dryer and its operating conditions for drying of pharmaceutical materials with the help of methods like case-based reasoning and decision trees to reduce time and expenditure for research. The work consisted of two major parts as follows: Literature survey on the theories of spray dying, case-based reasoning and decision trees; working part includes data acquisition and testing of the models based on existing and upgraded data. Testing resulted in a combination of two models, case-based reasoning and decision trees, leading to more specific results when compared to conventional methods.
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Communication is an essential element of good medical practice also in pathology. In contrast to technical or diagnostic skills, communication skills are not easy to define, teach, or assess. Rules almost do not exist. In this paper, which has a rather personal character and cannot be taken as a set of guidelines, important aspects of communication in pathology are explored. This includes what should be communicated to the pathologist on the pathology request form, communication between pathologists during internal (interpathologist) consultation, communication around frozen section diagnoses, modalities of communication of a final diagnosis, with whom and how critical and unexpected findings should be communicated, (in-)adequate routes of communication for pathology diagnoses, who will (or might) receive pathology reports, and what should be communicated and how in case of an error or a technical problem. An earlier more formal description of what the responsibilities are of a pathologist as communicator and as collaborator in a medical team is added in separate tables. The intention of the paper is to stimulate reflection and discussion rather than to formulate strict rules.
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BACKGROUND: Clinical guidelines are essential in implementing and maintaining nationwide stage-specific diagnostic and therapeutic standards. In 2011, the first German expert consensus guideline defined the evidence for diagnosis and treatment of early and locally advanced esophagogastric cancers. Here, we compare this guideline with other national guidelines as well as current literature. METHODS: The German S3-guideline used an approved development process with de novo literature research, international guideline adaptation, or good clinical practice. Other recent evidence-based national guidelines and current references were compared with German recommendations. RESULTS: In the German S3 and other Western guidelines, adenocarcinomas of the esophagogastric junction (AEG) are classified according to formerly defined AEG I-III subgroups due to the high surgical impact. To stage local disease, computed tomography of the chest and abdomen and endosonography are reinforced. In contrast, laparoscopy is optional for staging. Mucosal cancers (T1a) should be endoscopically resected "en-bloc" to allow complete histological evaluation of lateral and basal margins. For locally advanced cancers of the stomach or esophagogastric junction (≥T3N+), preferred treatment is preoperative and postoperative chemotherapy. Preoperative radiochemotherapy is an evidence-based alternative for large AEG type I-II tumors (≥T3N+). Additionally, some experts recommend treating T2 tumors with a similar approach, mainly because pretherapeutic staging is often considered to be unreliable. CONCLUSIONS: The German S3 guideline represents an up-to-date European position with regard to diagnosis, staging, and treatment recommendations for patients with locally advanced esophagogastric cancer. Effects of perioperative chemotherapy versus chemoradiotherapy are still to be investigated for adenocarcinoma of the cardia and the lower esophagus.
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This work aimed to characterize the chemical composition of samples of alcoholic beverages fermented from jabuticaba produced in five successive crops. Up to 2005 most of the results didn't meet the current legal standards for wines and there was a negative correlation between parameters such as pH and volatile acidity, pH and total acidity, volatile acidity and alcohol content (p<0.01). The implementation of Good Manufacturing Practices and must sulfitation during the 2006 harvest lowered volatile acidity and more than 60% of the samples were in accordance with legislation. Also, a significant improvement in alcohol content was found (p<0.05)
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The aim of this work was the single-laboratory validation of a quantitative method for the determination of amoxicillin residues in support of cleaning control and validation. Linearity was demonstrated between 2.5 and 17.5 μg/mL, without matrix effects. Mean recoveries ranged from 84.00 to 103.74% and the relative standard deviation under repetitivity and within-reproducibility conditions were from 0.58 to 4.20% and from 0.79 to 4.39%, respectively. The theoretical limits of detection and quantification were 0.133 and 0.442 μg/mL, respectively. The studied method was suitable for cleaning control purpose within good manufacturing practices.
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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.