Boas práticas de fabricação (BPF) aplicadas nas etapas de beneficiamento de um packing house de laranjas: estudo de caso

Pós-graduação em Agronomia (Energia na Agricultura) - FCA

Boas práticas de fabricação (bpf), análise de tomate e água em restaurantes da cidade de Botucatu-SP

Pós-graduação em Agronomia (Energia na Agricultura) - FCA

Avaliação dos perigos microbiológicos em uma indústria de beneficiamento de pescados e sugestão de um sistema de gestão de qualidade

Entre os produtos de origem animal os peixes são um dos mais susceptíveis à deterioração e podem representar risco para a saúde, se estiverem contaminados por micro-organismos patogênicos. Desta forma, as indústrias de pescado precisam ter cuidados especiais durante todas as etapas do processamento. Este estudo avaliou os perigos microbiológicos na linha de beneficiamento e produtos em uma indústria de pescado e propõe a sua adequação aos pré-requisitos necessários para a implantação do sistema de Análise de Perigos e Pontos Críticos de Controle (APPCC). Foram realizadas análises microbiológicas e físico-químicas em 144 amostras (filés e postas) de peixes congelados de diferentes espécies coletadas diretamente na indústria; foram também submetidas a análises microbiológicas 12 amostras de gelo, 24 amostras de água e 340 amostras de superfícies (equipamentos, utensílios e luvas de manipuladores). As Boas Práticas de Fabricação (BPF) foram avaliadas por meio de uma lista de verificação aplicada durante cinco vistorias na indústria. Foram realizados treinamentos e avaliadas as temperaturas de matérias-primas e de produtos semi-elaborados. Foi então proposto um plano APPCC para a linha de processamento de filé de peixe congelado. Entre os patógenos avaliados somente Estafilococos coagulase positiva foi detectado em 2,7% das amostras de peixes, resultado que está dentro do limite estabelecido na legislação brasileira. entretanto valores acima do estabelecido na legislação nacional para pl-! e B VT foram detectados em 18,1% e em 3,5% das amostras, respectivamente. Nas amostras de gelo e água não foram detectadas a presença de coliformes a 35°C e a 45°C. Do total de amostras de equipamentos e utensílios analisadas, 50% e 81,82% estavam dentro da recomendação estabelecida pela OPAS, de 1,7 log UFC/cm2 para mesófilos aeróbios e ausência de coliformes a 45°C, no primeiro e segundo período de coleta, respectivamente. As luvas, no primeiro período de coleta apresentaram contagem acima de 4 log UFC/luva de mesófilos aeróbios em 76,67% das amostras e no segundo período em apenas 21,67%. a avaliação das BPF nas duas primeiras vistorias a indústria foi classificada como de Risco Alto, por ter apresentado percentual de conformidades abaixo de 50%, e como de Risco Médio nas vistorias subsequentes, por ter atendido de 51 a 75% dos itens preconizados na lista de verificação. Com os resultados obtidos foi possível constatar que as BPF não estão totalmente implantadas na indústria analisada, detectando-se diversas não conformidades. A elaboração do plano APPCC seguiu as etapas: formação da equipe, descrição do produto, elaboração do fluxograma de produção, análise dos perigos, identificação dos Pontos Críticos de Controle (PCCs), estabelecimento de limites críticos e ações corretivas, e procedimentos de monitoração, registros e de verificação. A implementação do plano APPCC proposto é aplicável e pode contribuir, significativamente, para a elaboração de produtos de pescado com melhor qualidade e segurança alimentar.

Regulamentação Sanitária de Medicamentos

A regulamentação sanitária de medicamentos é uma das oito diretrizes da Política Nacional de Medicamentos. Trata-se da fiscalização e regulamentação de registro de medicamentos e da autorização de funcionamento desde os produtores até o varejo de medicamentos, bem como das restrições àqueles sujeitos a controle especial. A regulamentação sanitária de medicamentos tem como objetivo garantir eficácia, segurança, qualidade e custo aos produtos farmacêuticos. Os estudos clínicos dos medicamentos de Referência, a bioequivalência ou biodisponibilidade relativa e testes de equivalência dos medicamentos similares e genéricos são meios de avaliar a eficácia e a segurança. A qualidade é garantida lote a lote pelas Boas Práticas de Fabricação e Controle dos produtos farmacêuticos e a certificação da empresa pela ANVISA. O custo é avaliado pela câmara técnica de medicamento (CMED), que estabelece os critérios para fixação e ajuste de preços dos produtos farmacêuticos. No pós-registro, a efetividade, segurança e qualidade dos produtos são avaliadas por meio das comprovações exigidas na renovação do registro e, principalmente, pelo programa de farmacovigilância. Palavras-chave: Registro de Produtos. Medicamentos de Referência. Medicamentos Similares. Medicamentos Genéricos. Alteração de Registro de Produtos. ABSTRACT Health Regulations for Drugs The health regulation of drugs is one of eight guidelines issued within the National Drug Policy. It refers to the supervision and regulation of drug registration and the approval of operations, from the manufacturers to the retailers of medicines, as well as the restrictions that apply to drugs under special control. The health regulation of medicines is aimed at controlling the effectiveness, safety, quality and cost of pharmaceutical products. Clinical studies of brand-name (innovator) medicines, bioequivalence or relative bioavailability and the equivalence tests of generic and ‘similar’ brand-name drugs are means used to assess efficacy and safety. Quality is assured on a batch-to-batch basis by compliance with the Good Manufacturing Practices and Control of pharmaceutical products and by the certification of companies offered by ANVISA. The cost of a medicine is assessed by the Technical Chamber of Medicine (CMED), which establishes the criteria for setting and adjusting the prices of pharmaceutical products. After registration, the effectiveness, safety and quality of products are monitored by means of the tests required on renewal of registration and especially by the pharmacovigilance program. Keywords: Product Registration. Original Brand-name Drugs. Similar Drugs. Generic Drugs. Modification of Product Registration.

Análise retrospectiva e tendências do serviço de inspeção do estado de São Paulo

Pós-graduação em Medicina Veterinária - FCAV

Avaliação das boas práticas de fabricação em linha de processamento de queijos Minas frescal e ricota

In order to assure the maintenance of foods integrity and quality, for avoiding chemical, physical or biological contamination, it is essential to follow the Good Manufacturing Practices (GMP). Among the techniques used for evaluating GMP there is the observational analysis carried out by means of a check-list form application. The present study evaluated the suitability of GMP in a dairy industry producer of Minas fresh and ricotta cheeses, located in São José do Rio Preto, SP, by applying a check-list form. A significant improvement in conformity was evidenced, increasing from 43% to 78%. Neither the blocks related to the handlers nor the existing documentation in the company showed any improvements, as poor conditions unchanged. All of the other evaluated blocks showed significant improvement after applying the GMPrelated corrective measures. Based on these findings, the observance of corrective measures by the dairy industry on dairy products, physical environment, GMP, and handlers training was crucial for assuring the improvements and to increase the product quality and consumers safety.

Microbiota contaminante em bebidas lácteas fermentadas comerciais

Lately, the acceptability of fermented dairy beverages has been increased, due to the nutritional benefits, the practical consumption and the low cost of product for the manufacturers, and consequently for final market price to the consumers. During the manufacturing process, these products can be susceptible to microbiological contamination. The present study investigated the contaminant microbiota in fermented dairy beverages produced by small- and medium-sized companies, by means of analyses on moulds and yeasts counting, determination of the Most Probable Number (MPN) of total and thermo tolerant coliforms, Escherichia coli and Salmonella spp. detection, and determination of pH value. In spite of the absence of Salmonella spp., a high counts of yeasts and moulds were found, and E. coli was detected in five samples (16.67 %); and the sample were classified as “products in poor sanitary conditions”, because they showed thermo-tolerant coliforms counting higher than the standard established by the legislation in force. Therefore, quality programs such as Good Manufacturing Practices (GMP) and Hazard Analysis and Critical Control Points (HACCP) should be employed to prevent any contamination risk, in order to provide safe products to consumers.

Genetic heterogeneity of Escherichia coli isolated from pasteurized milk in State of Paraná, Brazil

Food contamination caused by enteric pathogens is a major cause of diarrheal disease worldwide, resulting in high morbidity and mortality and significant economic losses. Bacteria are important agents of foodborne diseases, particularly diarrheagenic Escherichia coli. The present study assessed the genetic diversity and antimicrobial resistance of E. coli isolates from pasteurized milk processed in 21 dairies in northwestern State of Parana, Brazil. The 95 E. coli isolates were subjected to antimicrobial susceptibility testing according to the recommendations of the Clinical and Laboratory Standards Institute and assessed genotypically by Enterobacterial Repetitive Intergenic Consensus-Polymerase Chain Reaction (ERIC-PCR). The highest rate of resistance was observed for cephalothin (55.78%). ERIC-PCR revealed high genetic diversity, clustering the 95 bacterial isolates into 90 different genotypic patterns. These results showed a heterogeneous population of E. coli in milk samples produced in the northwestern region of Parana and the need for good manufacturing practices throughout the processing of pasteurized milk to reduce the risk of foodborne illnesses.

Perfil socioeconômico e profissional de manipuladores de alimentos e o impacto positivo de um curso de capacitação em Boas Práticas de Fabricação

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES)

Análise retrospectiva da implantação do serviço de inspeção municipal de Rio Verde – GO e de microrganismos patogenicos em produtos cárneos

Pós-graduação em Medicina Veterinária - FCAV

Diagnóstico de situação da produção de linguiça frescal suína no município de Rio Verde/GO

Pós-graduação em Medicina Veterinária - FCAV

Musculoskeletal tissue regeneration by human non-embryonic stem cells

The aim of this thesis was to investigate the regenerative potential of alternative sources of stem cells, derived from human dental pulp (hDPSCs) and amniotic fluid (hAFSCs) and, specifically, to evaluate their capability to be committed towards osteogenic and myogenic lineages, for the eventual applicability of these stem cells to translational strategies in regenerative medicine of bone and skeletal muscle tissues. The in vitro bone production by stem cells may represent a radical breakthrough in the treatment of pathologies and traumas characterized by critical bone mass defects, with no medical or surgical solution. Human DPSCs and AFSCs were seeded and pre-differentiated on different scaffolds to test their capability to subsequently reach the osteogenic differentiation in vivo, in order to recover critical size bone defects. Fibroin scaffold resulted to be the best scaffold promoting mature bone formation and defect correction when combined to both hDPSCs and hAFSCs. This study also described a culture condition that might allow human DPSCs to be used for human cell therapy in compliance with good manufacturing practices (GMPs): the use of human serum (HS) promoted the expansion and the osteogenic differentiation of hDPSCs in vitro and, furthermore, allowed pre-differentiated hDPSCs to regenerate critical size bone defects in vivo. This thesis also showed that hDPSCs and hAFSCs can be differentiated towards the myogenic lineage in vitro, either when co-cultured with murine myoblasts and when differentiated alone after DNA demethylation treatment. Interestingly, when injected into dystrophic muscles of SCID/mdx mice - animal model of Duchenne Muscular Dystrophy (DMD) - hDPSCs and hAFSCs pre-differentiated after demethylating treatment were able to regenerate the skeletal muscle tissue and, particularly, to restore dystrophin expression. These observations suggest that human DPSCs and AFSCs might be eventually applied to translational strategies, in order to enhance the repair of injured skeletal muscles in DMD patients.

Use of antimicrobials in food-producing animals in Switzerland and in the European Union (EU)

The intensive and inappropriate use of antibiotics in both medicine and agriculture has selected for antibiotic resistant bacteria that cause severe problems in antibiotic therapy. In animal husbandry, antibiotics are used for therapeutic and preventive treatments of infectious diseases and as growth promoters. In Europe, many antibiotics used as growth promoters were of the same classes as important antibiotics used in human medicine. The European Union withdrew the authorization for the use of the major antimicrobial growth promoters between 1996 and 1999. In 1999 Switzerland decided to ban the use of all antimicrobials as growthpromoting feed additives. The regulations concerning antibiotic use in animal husbandry and the chronological reasons for the ban of antimicrobial growth promoters are described. This ban led to a decrease of the antibiotic volume deployed in agriculture. This measure helps to reduce the amount of antibiotic resistant bacteria in food-producing animals. However, the use of medicated feed is still a common practice to prevent and to remedy bacterial infections and thus still leads to resistant pathogens. Surveillance programs, single animal treatment, good manufacturing practices and vaccinations are additional measures to be taken to keep the level of resistances in bacteria low.

Surface microbial consortia from Livarot, a French smear-ripened cheese

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.

MICROBIOLOGICAL ANALYSIS OF TRADITIONALLY FERMENTED MILK SOLD IN KINIGI SECTOR OF MUSANZE DISTRICT IN RWANDA

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.