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.

Caracterização higiênico-sanitária de restaurantes comerciais do município de Botucatu-São Paulo

Pós-graduação em Medicina Veterinária - FMVZ

Frequência da cisticercose bovina no abate como índice de adoção das boas práticas agropecuárias

Pós-graduação em Medicina Veterinária - FCAV

Facilidades e dificuldades apontadas por professores de matemática ao atingir algumas das boas práticas de ensino

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES)

Situação da cisticercose bovina no Brasil

The taeniasis-cysticercosis complex is a long known zoonotic parasitosis characteristic of underdeveloped countries. In addition to its public health significance, this parasitosis is cause of economic losses to the beef production chain, and synonymous of technical inadequacy in relation to the adoption of Good Agricultural Practices. The occurrences of both human teniasis and bovine cysticercosis could and should be controlled with basic sanitary measures. However, there is much variation in the occurrence of the disease in cattle, characterizing a low rate of technical development as well as problems related to the adoption of basic sanitation measures. This review describes, in details, the causative agent and its epidemiological chain, besides raising current information about the occurrence of bovine cysticercosis in different regions of Brazil, aiming at the adoption of prophylactic measures by different segments responsible.

Differential environmental impacts on small and medium size rivers from center of São Paulo State, Brazil, and regional management perspectives

Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq)

Aspectos Nutricionais na Doença Renal Crônica em Cães

It is understood by Chronic Renal Failure (CRF) or Stage IV Chronic Kidney Disease (CKD) the morbid state in which there is a substantial and irreversible loss of functional capacity, metabolic and endocrine function in both kidneys, leading to a framework of dehydration, azotemia, electrolyte imbalance, anemia, uremic syndrome, secondary hyperparathyroidism, among other conditions that make the patient's life without treatment unfeasible. An adequate nutritional support to patients with CKD at any stage aims to maintain a good clinical condition and an attempt to delay the progression of the disease. The basis of a diet for patients with CKD is the restriction in this protein being of high biological value, low-phosphorus, high energy density, fiber and antioxidants combined with a good dietary practices that allow the patient a good quality of life

A importância da reserva legal para a preservação da fauna e flora existentes nas propriedades rurais de Botucatu

The main objective of this study was elaborating a diagnosis of technical conditions of Legal Reserves situation on the rural properties in Botucatu. In addition, considering the characteristics of fauna and flora and the economic aspects of these areas, it was presented alternatives to encourage the correct implantation and the effective preservation of the Legal Reserves. Because these areas contribute to the maintenance of local biodiversity and to availability of environmental services essential for all living creatures. In this study it was observed the presence of native vegetation in 13% of the rural properties’ areas in Botucatu, it is therefore necessary the recovery (reforestation) of 7% of all the rural properties’ areas, to be achieved the 20% of native vegetation (minimum area to be preserved as Legal Reserve, as disposed in Federal Law nº 12.651/12) on rural properties. A viable and significant alternative for recovery these areas, reinforced by the new forestry law, is the practice of sustainable management, that must be carried in harmony with conventional farming practices existing in the remaining areas of rural properties

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.

Percepção de risco sanitário na bovinocultura de corte no estado de São Paulo

Pós-graduação em Medicina Veterinária - FCAV

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.

Influência do manejo do solo em atributos químicos, físicos e microbiológicos dos córregos Jaboticabal e Cerradinho

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES)

Boas práticas de laboratório e biossegurança: prevenção dos riscos ergonômicos

El control de los riesgos ergonómicos es parte del paquete de medidas de Buenas Prácticas de Laboratorio y Bioseguridad. De este modo, la mala postura, la iluminación o ventilación inadecuadas , prolongada jornada de trabajo, la monotonía y la actividad repetitiva, intensa rutina, el control de la productividad , el estrés y el trabajo por la noche son factores a los riesgos ergonómicos. Como se relacionan a los elementos físicos y de organización también pueden interferir con la comodidad y la salud del personal de laboratorio. Riesgos ergonómicos no sólo pueden generar trastornos psicológicos y fisiológicos que causan graves daños a la salud, sino también comprometer la productividad del laboratorio y reducir el equipo de seguridad , ya que producen cambios en el cuerpo y el estado emocional, tales como trastornos o lesiones relacionadas con el cansancio físico producido por el trabajo repetitivo, dolor muscular, alteraciones del sueño, diabetes, trastornos de los nervios , la taquicardia , las enfermedades del aparato digestivo (gastritis y úlcera ), tensión, ansiedad, problemas de espalda y la hipertensión. En este trabajo se propone una secuencia de actividad laboral (gimnasia) en el intervalo de tiempo pequeño, respetando las instalaciones y el espacio físico disponible en el ambiente del trabajo, como una estrategia para mejorar la calidad de vida laboral, para aumentar la productividad, mejorar la disposición a trabajar y para aumentar el conocimiento del cuerpo y de la interacción social.