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.

Processo de seleção do sexo de espermatozóides mamíferos e método de controle de qualidade de doses de sêmen sexado congelado

A presente invenção permite produzir por centrifugação em gradiente de densidade, em empresas especializadas na produção e comercialização de sêmen congelado, doses de sêmen enriquecidas com espermatozóides portadores do cromossomo X ou Y, sem comprometer a capacidade fecundante destes espermatozóides. Pela presente invenção, doses de espermatozóides contendo ambos espermatozóides X e Y podem ser separadas para produzir sub populações de espermatozóides enriquecidas em portadores do cromossomo X ou Y, as quais são substancialmente puras em relação ao espermatozóide desejado e substancialmente livres do outro tipo de espermatozóide.

Qualidade da pulverização em volume reduzido para o controle do bicho-mineiro Leucoptera coffeella (Guérin-Mèneville & Perrottet, 1842) (Lepidoptera: Lyonetiidae)

Pós-graduação em Agronomia (Entomologia Agrícola) - FCAV

Controle de qualidade em equipamentos mamográficos

Nowadays the mammography is the most effective way of revealing early breast cancer. The image in this kind of exam is gotten trough a x-ray sheaf of low energy, however, the suitable visualization of the interesting structures by the radiologist is not always possible due several factors that appears since the mamma composition until the equipments limitation. The regulation 453/98 sets quality control tests and limits of acceptation that guarantee a good development of the mammographys. The purpose of this study is the 3D principle ( Diagnostic, Dose and Dollar), that means, an improved diagnosis, a dose reduction in the patient and a cost decrease for the Institution. In this study was made the quality control tests set by the Regulation in two mammography equipments from Hospital das Clínicas da Faculdade de Medicina de Botucatu (HCFMB - UNESP). The results reached in this research were used in the renovation process of quality stamp in mammography granted by Colégio Brasileiro de Radiologia (CBR) to the diagnosis by image from the HCFMB – UNESP

Controle de qualidade em equipamentos de tomografia computadorizada

The computed tomography, devised by Godfrey Hounsfield and Allan Cormack, is in its fourth decade of the clinical use and has presented to be a very useful tool in the diagnosis of several pathologies. For this reason, its use is increasing each day, due to technological progress since its creation. Due to be more and more utilized, the equipment must be in good operating conditions, because it is subject to variance and wearing, damage the quality of diagnosis. To evaluate whether the performance of the scanner remains constant along the time and the dose received by the patient is within the desired limits, periodic tests of quality control must be performed. For this subject, the regulation 453 (June 01, 1998) was created, which determines the need of the implementation of a program for quality assurance (PGQ), where, in addition to the tests of quality control, are established the necessary measurements for the proper functioning of the equipment, generating a trustworthy diagnosis, reducing the dose for the patient and the costs. In this document, are presented tests of quality control carried out in hospitals of the city of Sao Paulo carried out together with the Technical Section of Applications by Imaging Diagnostic (STADI) of the Institute of Electrotechnics and Energy of the University of São Paulo (IEE/USP)

Avaliação da qualidade de comprimidos de captopril 50 mg comercializados no Brasil

O captopril foi o primeiro agente desenvolvido para o tratamento da hipertensão, doença que acomete grande parte da população adulta mundial, a qual requer cuidados especiais quanto à farmacoterapia e ajuste de doses. Assim sendo, este trabalho tem como objetivo avaliar a qualidade de comprimidos de captopril 50 mg comercializados no Brasil através da realização da equivalência farmacêutica entre duas marcas de comprimidos não revestidos de captopril 50 mg (um genérico G e um similar S) em relação ao medicamento referência (R) Capoten® Bristol Myers Squibb 50 mg, utilizando os requisitos descritos na monografia individual do fármaco da Farmacopeia Brasileira e da Farmacopeia Americana. Medicamentos referência são produtos inovadores, cuja eficácia, segurança e qualidade foram comprovadas cientificamente; os chamados similares são os que contêm as mesmas substâncias ativas, mesma concentração, forma farmacêutica, via de administração, posologia e indicação terapêutica do medicamento de referência e são identificados por nome comercial ou por sua marca; os medicamentos genéricos são intercambiáveis com o produto referência e, geralmente, são produzido após a expiração ou renúncia da proteção patentária do mesmo, ele deve ser designado pela DCB (Denominação Comum Brasileira) ou, na ausência desta, pela DCI (Denominação Comum Internacional). Os dois medicamentos analisados, medicamento similar e medicamento genérico, apresentaram resultados satisfatórios quanto à determinação de peso médio, resistência mecânica e tempo de desintegração dos comprimidos, identificação, doseamento, limite de dissulfeto de captopril, uniformidade de doses unitárias, teste de dissolução e perfil de dissolução do fármaco, com relação ao seu medicamento referência correspondente, ou seja, estes são equivalentes farmacêuticos e apresentam qualidade... (Resumo completo, clicar acesso eletrônico abaixo)

Dosimetria Física e Controle de Qualidade em Radioterapia

Radiotherapy is a multidisciplinary speciality which uses complex equipment and radiation sources for delivery of treatment, using high-energy ionizing radiation to treat cancer at several stages of complexity. Since radiation therapy is a technique which involves a precalculated radiation dose, it shall be established quality assurance programs that provide an efficient and safety treatment. The International Commission on Radiation Units and Measurements (ICRU) report No. 50 has recommended dose uniformity between 5% of the prescribed dose throughout the region of interest. This is one of the most primordial points that justify the importance of a suitable attendance of the equipments quality and performance. For quality control, the medical physicist will be involved with establishing and running a Quality Control Program (QCP). He must adapt or develop the procedures of equipment acceptance and commissioning, besides verifying the use of principles and accepted protocols of national and international reports to assure the correct quality, quantity, and placement of radiation during the performance of a radiological procedure, establishing adequate protocols to ensure accurate patient dosimetry. This present work consists of a description of the activities carried through the Sectors of Radiation Therapy of the Hospital of Clinics of the Campinas State University (Unicamp), particularly in the implementation of the Quality Control Program

Controle de qualidade em radioterapia: dosimetria de fótons em acelerador linear – Mevatron MXT

The treatment of a tumor with ionizing radiation is an ongoing process with well differentiated stages. These ones include the tumor diagnosis and location, the decision on the treatment strategy, the absorbed dose planning and calculation, the treatment administration, the absorbed dose verification and the evaluation of results in short and long terms. The quality of a radiotherapy procedure is closely linked to factors that may be classified as clinical, such as the diagnosis, the tumor location, the treatment strategy chosen and the continuous treatment reassessment; dosimetric or physical, such as the uncertainty in the dose calculation, its optimization and verification, the suitability of the equipment to provide a radiation beam consistent with the treatment planning; finally, others which are related to the practical application of radiotherapy treatment and the handling of the patient. In order to analyze the radiotherapy quality, one should realize that the three aspects (medical, physical or dosimetric and practical application) should be considered in a combined way. This means that numerous actions of the radiotherapists, medical physicists and technicians in radiotherapy should be held jointly and their knowledge level will significantly affect the treatment quality. In this study, the main physical parameters used in dosimetry are defined as well as determined experimentally for a linear accelerator Mevatron - MXT. With this, it is intended to provide recommendations for the physical aspects of Quality Assurance (QA) in the radiotherapy treatments, and these will usually be applied by professionals in Medical Physics. In addition to these instructions, it is recommended that additional texts are prepared to address in detail the clinical aspects of the treatments QA

Coleta de dados, modelagem e controle de qualidade do sistema de planejamento pinnacle3

Qualidade na coleta de dados do feixe de radiação, modelagem por meio do sistema de planejamento de tratamento (SPT) e controle da qualidade do processo envolvido são cruciais à fidedignidade do serviço de radioterapia de forma a contribuir à eficácia do tratamento e segurança do principal ente envolvido no final de toda essa sistemática, o paciente. Para isso foi proposto nesse presente trabalho a coleta de dados do feixe de raios-x de 6MV seguido da introdução desses dados ao SPT para processo de modelagem computacional que teve agregado, a todo esses processos, o controle da qualidade segundo critérios de aceitação

Comparação entre metodologias de controle de qualidade em mamografia digital

The best way to detect breast cancer is by screening mammography. The mammography equipments are dedicated and require a rigorous quality control in order to have a good quality image and to early detect this disease. The digital equipment is relatively new in the market and there isn’t a national rule for quality control for several types of digital detectors. This study has proposed to compare two different tests manuals for quality control provided by the manufacturers of digital mammography equipments, and also compare them to the “European guidelines for quality assurance in breast cancer screening and diagnosis “(2006). The studied equipments were: Senographe 2000D from General Electric (GE) and the Hologic Selenia Lorad. Both were digital mammography equipments, the GE unit presents an indirect digital system and the other presents a direct digital system. Physical parameters of the image have been studied, such as spatial resolution, contrast resolution, noise, signal-tonoise ratio, contrast-to-noise ratio and modulation transfer function. After that, a study of the importance of quality control and the requirement to implement a Quality Assurance Program has been done. One data collection was done to compare those manual, it was done by checking which tests are indicated and the minimum frequency which they should be conducted in accordance with each manufacturer. The tests were performed by different methodologies and the results were compared. The examined tests were: the breast entrance skin dose, mean glandular dose, contrast-to-noise ratio, signal-to-noise ratio, automatic exposure control and automatic control of density, modulation transfer function, equipment resolution, homogeneity and ghost

Processamento e qualidade higiênico-sanitária do pescado: se tiver subtitulo

The fishery products are sources of protein of high biological value and an important component in a balanced diet. However, they are highly subject to deterioration, which represents a serious risk to public health. Thus, rigorous methods are needed for quality assurance of fish in all stages of the production chain. Traditionally, the Brazilian population does not have the habit of eating fish, although the country presents a great potential for aquaculture, which is underexploited. The consumption of fish is limited by socio-economic factors. Currently, the search for food security is a global trend. Thus, it is necessary to change the profile of the consumer, by offering a competitive and safe food. In this paper, we address issues related to quality, hygiene and health of fish

Otimização de procedimentos de controle de qualidade em equipamentos radiográficos convencionais do Instituto de Eletrotécnica e Energia - USP

Radiography is currently an important method of diagnosis, both medical, dental and veterinary. The image in this type of survey is obtained using an X-ray beam, where the radiologist can possibly view structures of interest. It isn't always possible to get the desired images due to various factors, such as equipment limitations. The Administrative Law 453/98, the State Resolution SS 625/94, and other standards require testing and quality control acceptance limits that guarantee a good performance of the equipment for the security and quality of care, giving service users greater effectiveness in exams. This study were performed in the accompaniment of testing procedures for quality control established by Administrative Law 453/98 in several X-ray equipment to make a comparison and optimization in the descriptions of the procedures used by the Institute for Electrical Energy and the University of São Paulo (IEE / USP / SP).The optimization of the procedures were performed with the aid of a current literature, the Resolution 453/98, State Resolution SS 625/94 and other international standards. On this basis it was possible to observe the importance of regular monitoring of tests for an update, following the technological development of instruments used in the service

Análise de polimorfismos da região controle do DNA mitocondrial em indivíduos residentes na região da grande São Paulo para utilização na identificação humana

A identificação humana através da análise de DNA utiliza o perfil genético de um indivíduo baseado na combinação de diversos marcadores que são herdados de seus progenitores. Esses marcadores são geralmente diferenças nas sequências de DNA nuclear entre os indivíduos (polimorfismos). Em alguns casos, entretanto, a análise do DNA nuclear não pode ser aplicada, isso ocorre quando o DNA da amostra apresenta-se degradado ou em casos onde o material biológico não apresenta o DNA nuclear. Nestes casos, a análise do DNA mitocondrial (DNA mt) é o método de escolha (PANETO, 2010). O objetivo deste trabalho foi estudar os polimorfismos presentes na região controle do DNA mt em 60 indivíduos, residentes na região da Grande São Paulo, para utilização na identificação humana. A extração de sangue foi realizada utilizando o FTA Reagente e a região controle do DNA mt foi amplificada por PCR e sequenciada em ambas as fitas utilizando o BigDye v.3.1. Posteriormente, as amostras foram submetidas à eletroforese capilar em sequenciador ABI 3500. As amostras foram analisadas estatisticamente e classificadas em haplogrupos. De um total de 57 amostras com seqüenciamento de qualidade, 56 haplótipos diferentes foram encontrados quando analisamos toda a região hipervariável do DNA mt. E a análise da região HV3 associada às outras regiões hipervariáveis aumentou o poder discriminatório entre os indivíduos Assim, pretende-se utilizar os resultados do projeto no auxílio da elucidação de casos forenses pela polícia científica

Controle de qualidade em estruturas na construção civil

This work is to control the quality of the structures, procedures for addressing the assembly of the formwork, scaffolding and the frame of pillars, beams and slabs. He had also intended to show that the vibration of launch and concrete items are also important, if poorly implemented can undermine the structure. This work also shows that the mapping becomes essential if there is some problem in the concrete, where concrete was launched, could be identified. And finally check the product where the structure will be evaluated for how much their quality

Testes de Controle de Qualidade em Sistema de Processamento Computadorizado FUJI

Computed Radiography (CR) is a term used to describe the system that electronically records a radiographic image. CR systems use receivers or IP (imaging plate) to capture the analog signals and then allow the readers to do the image processing and converted into digital information. With the increasing expansion of the CR for medical diagnostics it is necessary that these systems receive the same type of monitoring related to Quality Control and Acceptance to the conventional processing systems. The current legislation fails to specify the parameters and procedures to be tested, allowing that somehow, some equipment is not fully able to use in clinical routine. In this project we used the standard AAPM Report Number 93, which is already fully established outside the country and displays all test parameters in CR. From there were chosen three types of tests that were performed in a satisfactory sampling of IP´s. With this procedure it was possible to establish which of those IP's should be out of use, which reveals the important purpose of the study, demonstrating the need for Quality Control Testing and Acceptance in Computerized Radiography as soon as possible are included in the legislation regulator in the country