932 resultados para Good Manufacturing Practice
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Global G.A.P. is a one of the most influential private standards in the area of food safety and sustainability. With increasing impacts of Global G.A.P., many Asian countries have introduced the country versions of GAPs; China GAP, Japan GAP, Viet GAP, Thai GAP and ASEAN GAP. Each has been influenced by Global G.A.P. but ways of implementation, implementation bodies as well as focus differ from each other. This paper examines the development and motivation behind how the Asian GAPs have been introduced both from current situation and from historical perspectives. Then we compare current situation of different Asian GAPs.
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The high number of import rejections of food commodities suggests that producers in exporting countries are not complying with established standards. To understand why this is the case, we explore the behavior of producers and consumers in developing countries. First, we examine the successful transformation of production practices adopted by shrimp producers in Thailand. In support of the dramatic change in practices, we observe an important role played by the public sector in providing a means to visualize chemical residues and to control processes upstream of the supply chain via a registration system and a traceability system called Movement Document. Furthermore, very active information sharing by the private sector contributes to the dissemination of useful technical and market information among producers. We also examine the knowledge and perceptions of consumers with respect to food safety in Vietnam. We find that consumers in Hanoi and Ho Chi Minh City behave differently toward the third-party certification VietGAP, probably owing to differences in the history of market mechanisms between the two cities.
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Thesis (Master's)--University of Washington, 2016-06
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This article analyses the way newspapers and journalists sometimes fail to acknowledge and resolve some of the contentious ethical dilemmas associated with reporting news. Its focus is on not exploiting and vilifying the vulnerable, especially people with mental illness, through sensationalism and inaccurate and imprecise use of medical terminology such as "psycho ". "schizo" or "lunatic ". Because ethics is central to our understanding of professionalism, this article uses professions and professionalism as benchmarks aginst which to analyse and critique how journalists and newspapers define and report news.Sometimes journalists fail the test of good ethical practice in terms of negative. outdated and inaccurate expressions they use in the news stories they report. Likewise, regulators of news industry standards appear not to recognize and sanction such reporting. The apparent inability to resolve these ethical dilemmas creates a context conducive to tolerance for, not acceptance of. unethical news reporting.
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Monocyte-derived dendritic cells (MoDCs) in clinical use for cancer immunotherapy are ideally generated in serum-free medium (SFM) with inclusion of a suitable maturation factor toward the end of the incubation period. Three good manfacturing practice (GMP) grade SFMs (AIM-V, X-VIVO 15, and X-VIVO 20) were compared with RPMI-1640, supplemented with 10% fetal bovine serum or 10% human serum. DCs generated for 7 days in SFM were less mature and secreted less interleukin (IL) 12p70 and IL-10 than DCs generated in 10% serum. DC yield was comparable in SFMs, and a greater proportion of cells was viable after maturation. Toll-like receptor (TLR) ligands were compared for their ability to induce cytokine secretion under serum-free conditions in the presence of interferon (IFN) gamma. With the exception of Poly I:C, TLR ligands stimulated high levels of IL-10 secretion. High levels of IL-12p70 were induced by two TLR4-mediated stimuli, lipopolysaccharide and Ribomunyl, a clinical-grade bacterial extract. When T-cell responses were compared in allogeneic mixed leukocyte reaction, DCs stimulated with Ribomunyl induced higher levels of IFN gamma than DCs stimulated with the cytokine cocktail: tumor necrosis factor-alpha, IL-1 beta, IL-6, and prostaglandin E-2. In the presence of IL-10 neutralizing antibodies, DC IL-12p70 production and T-cell IFN gamma were increased in vitro. Similarly, DCs stimulated with Ribomunyl, IFN gamma, and anti-IL-10 induced high levels of tetanus toxoid-specific T-cell proliferation and IFN gamma secretion. Thus, MoDCs generated ill SFM efficiently stimulate T-cell IFN gamma production after maturation in the presence of a clinical-grade TLR4 agonist and IL-10 neutralization.
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This paper reports the initial results of a joint research project carried out by Aston University and Lloyd's Register to develop a practical method of assessing neural network applications. A set of assessment guidelines for neural network applications were developed and tested on two applications. These case studies showed that it is practical to assess neural networks in a statistical pattern recognition framework. However there is need for more standardisation in neural network technology and a wider takeup of good development practice amongst the neural network community.
The effective use of implicit parallelism through the use of an object-oriented programming language
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This thesis explores translating well-written sequential programs in a subset of the Eiffel programming language - without syntactic or semantic extensions - into parallelised programs for execution on a distributed architecture. The main focus is on constructing two object-oriented models: a theoretical self-contained model of concurrency which enables a simplified second model for implementing the compiling process. There is a further presentation of principles that, if followed, maximise the potential levels of parallelism. Model of Concurrency. The concurrency model is designed to be a straightforward target for mapping sequential programs onto, thus making them parallel. It aids the compilation process by providing a high level of abstraction, including a useful model of parallel behaviour which enables easy incorporation of message interchange, locking, and synchronization of objects. Further, the model is sufficient such that a compiler can and has been practically built. Model of Compilation. The compilation-model's structure is based upon an object-oriented view of grammar descriptions and capitalises on both a recursive-descent style of processing and abstract syntax trees to perform the parsing. A composite-object view with an attribute grammar style of processing is used to extract sufficient semantic information for the parallelisation (i.e. code-generation) phase. Programming Principles. The set of principles presented are based upon information hiding, sharing and containment of objects and the dividing up of methods on the basis of a command/query division. When followed, the level of potential parallelism within the presented concurrency model is maximised. Further, these principles naturally arise from good programming practice. Summary. In summary this thesis shows that it is possible to compile well-written programs, written in a subset of Eiffel, into parallel programs without any syntactic additions or semantic alterations to Eiffel: i.e. no parallel primitives are added, and the parallel program is modelled to execute with equivalent semantics to the sequential version. If the programming principles are followed, a parallelised program achieves the maximum level of potential parallelisation within the concurrency model.
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The societal cost for the average health authority in the United Kingdom for the care of wet age-related macular degeneration (AMD) has been suggested to be around £7.4 million. It is vital that the best possible care based on the best available evidence is provided to reduce the impact of AMD on patients' lives and the financial cost to the health-care system. This study explored the experiences of AMD patients treated with intravitreal ranibizumab injections. Three semistructured interviews were conducted with seven participants over the course of 18 months. Transcripts were analysed using interpretative phenomenological analysis. Analysis identified four themes: preparing for treatment, the treatment process, patient-provider communication, and results of treatment. Patient experiences highlighted the need to move away from the reliance on letters for information provision, and the need for clearer guidelines about when to cease AMD treatment. Interviews highlighted the need for the inclusion of rigorous qualitative evidence with experiential data in future good clinical practice guideline development for AMD. © The Author(s) 2013.
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The surface microflora (902 isolates) of Livarot cheeses from three dairies was investigated during ripening. Yeasts were mainly identified by Fourier transform infrared spectroscopy. Geotrichum candidum was the dominating yeast among 10 species. Bacteria were identified using Biotype 100 strips, dereplicated by repetitive extragenic palindromic PCR (rep-PCR); 156 representative strains were identified by either BOX-PCR or (GTG) 55-PCR, and when appropriate by 16S rDNA sequencing and SDS-PAGE analysis. Gram-positive bacteria accounted for 65% of the isolates and were mainly assigned to the genera Arthrobacter, Brevibacterium, Corynebacterium, and Staphylococcus. New taxa related to the genera Agrococcus and Leucobacter were found. Yeast and Gram-positive bacteria strains deliberately added as smearing agents were sometimes undetected during ripening. Thirty-two percent of the isolates were Gram-negative bacteria, which showed a high level of diversity and mainly included members of the genera Alcaligenes, Hafnia, Proteus, Pseudomonas, and Psychrobacter. Whatever the milk used (pasteurized or unpasteurized), similar levels of biodiversity were observed in the three dairies, all of which had efficient cleaning procedures and good manufacturing practices. It appears that some of the Gramnegative bacteria identified should now be regarded as potentially useful in some cheese technologies. The assessment of their positive versus negative role should be objectively examined.
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To explore the views of pharmacy and rheumatology stakeholders about system-related barriers to medicines optimisation activities with young people with long-term conditions. A three-phase consensus-building study comprising (1) focus groups with community and hospital pharmacists; (2) semi-structured telephone interviews with lay and professional adolescent rheumatology stakeholders and pharmacy policymakers, and (3) multidisciplinary discussion groups with community and hospital pharmacists and rheumatology staff. Qualitative verbatim transcripts from phases 1 and 2 were subjected to framework analysis. Themes from phase 1 underpinned a briefing for phase 2 interviewees. Themes from phases 1 and 2 generated elements of good pharmacy practice and current/future pharmacy roles for ranking in phase 3. Results from phase 3 prioritisation and ranking exercises were captured on self-completion data collection forms, entered into an Excel spreadsheet and subjected to descriptive statistical analysis. Institutional ethical approval was given by Aston University Health and Life Sciences Research Ethics Committee. Four focus groups were conducted with 18 pharmacists across England, Scotland and Wales (7 hospital, 10 community and 1 community/public health). Fifteen stakeholders took part in telephone interviews (3 pharmacist commissioners; 2 pharmacist policymakers; 2 pharmacy staff members (1 community and 1 hospital); 4 rheumatologists; 1 specialist nurse, and 3 lay juvenile arthritis advocates). Twenty-five participants took part in three discussion groups in adolescent rheumatology centres across England and Scotland (9 community pharmacists; 4 hospital pharmacists; 6 rheumatologists; 5 specialist nurses, and 1 physiotherapist). In all phases of the study, system-level issues were acknowledged as barriers to more engagement with young people and families. Community pharmacists in the focus groups reported that opportunities for engaging with young people were low if parents collected prescriptions alone, which was agreed by other stakeholders. Moreover, institutional/company prescription collection policies – an activity largely disallowed for a young person under 16 without an accompanying parent - were identified by hospital and community pharmacists as barriers to open discussion and engagement. Few community pharmacists reported using Medicines Use Review (England/Wales) or Chronic Medication Service (Scotland) as a medicines optimisation activity with young people; many were unsure about consent procedures. Despite these limitations, rheumatology stakeholders ranked highly the potential of pharmacists empowering young people with general health care skills, such as repeat prescription ordering. The pharmacy profession lacks vision for its role in the care of young people with long-term conditions. Pharmacists and rheumatology stakeholders identified system-level barriers to more engagement with young people who take medicines regularly. We acknowledge that the modest number of participants may have had a specific interest and thus bias for the topic, but this underscores their frank admission of the challenges. Professional guidance and policy, practice frameworks and institutional/company policies must promote flexibility for pharmacy staff to recognise and empower young people who are able to give consent and take responsibility for medicines activities. This will increase mutual confidence and trust, and foster pharmacy’s role in teaching general health care skills. In this way, pharmacists will be able to build long-term relationships with young people and families.
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Background Sweet cherries (Prunus avium L.) are a nutritious fruit which are rich in polyphenols and have high antioxidant potential. Most sweet cherries are consumed fresh and a small proportion of the total sweet cherries production is value added to make processed food products. Sweet cherries are highly perishable fruit with a short harvest season, therefore extensive preservation and processing methods have been developed for the extension of their shelf-life and distribution of their products. Scope and Approach In this review, the main physicochemical properties of sweet cherries, as well as bioactive components and their determination methods are described. The study emphasises the recent progress of postharvest technology, such as controlled/modified atmosphere storage, edible coatings, irradiation, and biological control agents, to maintain sweet cherries for the fresh market. Valorisations of second-grade sweet cherries, as well as trends for the diversification of cherry products for future studies are also discussed. Key Findings and Conclusions Sweet cherry fruit have a short harvest period and marketing window. The major loss in quality after harvest include moisture loss, softening, decay and stem browning. Without compromising their eating quality, the extension in fruit quality and shelf-life for sweet cherries is feasible by means of combination of good handling practice and applications of appropriate postharvest technology. With the drive of health-food sector, the potential of using second class cherries including cherry stems as a source of bioactive compound extraction is high, as cherry fruit is well-known for being rich in health-promoting components.
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A research work entitled: “Microbiological analysis of traditionally fermented milk (Ikivuguto) sold in Kinigi Sector of Musanze District,” was carried out at Higher Learning Institution of Applied Sciences (INES-Ruhengeri) Laboratory of Microbiology located near Volcanoes in the Northern Province of Rwanda. The main objective of this work was to determine the microbiological quality of traditionally fermented milk, which is consumed by Kinigi Center local people. The hypothesis was to analyze if traditionally fermented milk commercialized in Kinigi restaurants contained pathogenic bacteria such as fecal coliforms and Escherichia coli , in addition to staphylococci and yeasts. Milk samples were collected from Kinigi sector and examined in the microbiology laboratory in order to assess the microbiological quality and safety of traditionally fermented milk in rural areas. The samples were analyzed qualitatively and quantitatively for the microbes found in fermented milk sold in Kinigi Center, and the results were as follows: 7.21x107 CFU/ml for total counts; 3.89x107 CFU/ml for Lactobacillus ; 2.77x107 CFU/ml for yeasts; 1.196x105 CFU/ml for total coliforms; 9.63x104 CFU/ml for fecal coliforms and 8.92x103 CFU/ml for staphylococci. Biochemical tests were carried out and the results showed that identified pathogens were E. coli, Providencia alcalifaciens , and the staphylococci group. It was found that fermented milk contained genera and species of Staphylococcus haemolyticus , Staphylococcus aureus , Staphylococcus intermedius , Staphylococcus xylosus and Staphylococcus saprophyticus . Findings showed that the commercial milk samples were cross-contaminated by different pathogens from environment. These contaminations could have been due to improper handling, presence of flies, soil erosion, dust from atmosphere, as well as contaminated milk vessels or pots, stirrers and unpasteurized water. It was concluded that local farmers and milk retailers did not adhere to required hygienic conditions for milk safety. In this regard, the sold traditional fermented milk does not meet health and safety standards because people did not respect good manufacturing practices. The hypothesis and main objective were confirmed, because traditionally fermented milk of Kinigi was cross-contaminated before consumption. Thus, it would be better to train farmers in the areas of product hygiene, sanitation and safety during milking, processing and marketing.
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Introdução: O burnout é uma síndrome psicológica, caracterizada por elevada exaustão emocional, elevada despersonalização e baixa realização profissional, que conduz à erosão dos valores pessoais, profissionais e de saúde. Este estudo reporta a prevalência do burnout em profissionais de saúde Portugueses. Material e Métodos: Os níveis de burnout foram estimados pelo Maslach Burnout Inventory - Human Services Survey numa escala ordinal de zero (nunca) a seis (sempre) pontos. A amostra foi constituída por 1 262 enfermeiros e 466 médicos com médias de idade de 36,8 anos (DP = 12,2) e 38,7 (DP = 11,0), respetivamente. Os participantes foram provenientes de todos os distritos nacionais (35% Lisboa; 18% Porto; 6% Aveiro, 6% Setúbal, 5% Coimbra; 5% regiões autónomas), com atuação em meio hospitalar (54%), centros de saúde (Unidade de Saúde Familiar - 30%; Unidades de Cuidados de Saúde Primários - 8%) e outras instituições públicas/privadas (8%). Resultados: A análise dos níveis de burnout revelou que ambas as categorias profissionais apresentaram níveis moderados a elevados de burnout (M = 3,0; DP = 1,7) não sendo significativas as diferenças entre as duas profissões. Vila Real (M = 3,8; SD = 1,7) e a Madeira (M = 2,5; DP = 1,5) são as regiões onde os níveis de burnout são mais e menos elevados, respetivamente. Os níveis de burnout não diferiram significativamente entre Hospitais, Unidades de Cuidados de Saúde Personalizados e Unidades de Saúde Familiares. Os profissionais com maior tempo na função são menos acometidos por burnout (r = -0,15) não ocorrendo associação significativa com a duração da jornada de trabalho (r = 0,04). A má qualidade das condições de trabalho foi o melhor preditor do burnout (r = -0,35). Discussão: A ocorrência da síndrome de burnout em profissionais de saúde portugueses é frequente, estando associada à percepção de más condições de trabalho e à menor duração do tempo de serviço. A incidência de burnout apresenta diferenças regionais que podem estar associadas ao aumento do stress imposto pelo exercício da profissão em condições sub-ótimas para a prestação dos cuidados de saúde. Os resultados alertam para a necessidade de intervenções para melhorar as condições de trabalho e formação inicial dos profissionais de saúde de forma a garantir a qualidade do serviço prestado aos utentes e o bem-estar pessoal destes profissionais. Conclusões: A nível nacional, entre 2011 e 2013, 21,6% dos profissionais de saúde apresentaram burnout moderado e 47,8% burnout elevado. A perceção de más condições de trabalho foi o principal preditor da ocorrência de burnout nos profissionais de saúde Portugueses.
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Il settore farmaceutico è regolato da numerose norme e linee guida al fine di tutelare la salute del consumatore. Infatti, il principio generale che governa lo sviluppo e l’operabilità di un impianto farmaceutico prevede che l’utilizzatore debba fornire l’evidenza documentale che il sistema sia “qualificato” e che il processo produttivo che in esso risiede sia “convalidato” e mantenuto in tale stato. Sulla base di quanto detto risulta essenziale, prima dell'accettazione alla produzione di un nuovo farmaco, che venga confermata una valutazione esatta e affidabile per la sua realizzazione e per la sicurezza degli utilizzatori, garantendone la qualità. Tale elaborato è volto ad analizzare suddetta gestione delle richieste normative in ambito di qualifica dei sistemi farmaceutici, come frutto di un’esperienza formativa svolta presso lo stabilimento di Termoli (CB) della F.I.S. – Fabbrica Italiana Sintetici S.p.A. Il processo di qualifica è stato messo in atto per l’installazione di una nuova centrifuga e per la mappatura termo-igrometrica del nuovo magazzino automatizzato dello stabilimento. Nello specifico, i due casi studio esaminati sono stati individuati grazia ad una prima presentazione del sistema inquadrato nella produzione di principi attivi farmaceutici, seguita dall’analisi dei protocolli (standard e non) di qualifica da compilare nella fase esecutiva. Nell’elaborato sono stata presentate e comparate le normative e le linee guide vigenti del settore, quali EU GMP Guidelines, ISPE Baseline Guide e UNI EN ISO 9001:2015 per la gestione della qualità, e le procedure aziendali, nell’ottica delle norme di buona documentazione e del rispetto del data integrity. L’esecuzione dei due progetti ha permesso l’avvio e la messa in esercizio di sistemi critici per la produzione di principi attivi farmaceutici, garantendo il miglioramento delle prestazioni complessive dell’impianto.
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