A pré-qualificação de medicamentos: análise comparativa entre OMS e Anvisa

The production of medicines with quality, safety and efficacy is essential to meet national and international requirements, aiming at subsidizing pharmaceutical care within the public health. Given the strategic role in which the public health industrial complex is inserted, compliance with Good Manufacturing Practices (GMP) of the World Health Organization (WHO) is essential to export its drugs via international organizations. The objectives of this article were to identify the main technical requirements recommended by WHO and enforced by the Brazilian Health Regulatory Agency (Anvisa), for compliance and recognition of GMP for medicinal products, and to compare them critically, to obtain the prequalification of medicines. This literature and documentary review promoted a comprehensive approach on national regulations and WHO guidelines. This work enabled to show a high degree of harmonization concerning the topics/subtopics compared between WHO and the national standards guides imposed by Anvisa about GMP, which demonstrates an integration of the national legislation in the international context, corroborating the alignment between Anvisa and WHO regarding compliance with GMP.A produção de medicamentos com qualidade, segurança e eficácia é fundamental para atender às demandas nacionais e internacionais, com o fito de subsidiar a assistência farmacêutica no âmbito da saúde pública. Diante do papel estratégico em que o complexo fabril público de saúde está inserido, o cumprimento das Boas Práticas de Fabricação (BPF) da Organização Mundial de Saúde (OMS) é essencial para a exportação de seus medicamentos via organismos internacionais. Os objetivos deste artigo foram identificar os principais requisitos técnicos recomendados pela OMS e exigidos pela Agência Nacional de Vigilância Sanitária (Anvisa), para o cumprimento e reconhecimento das BPF de medicamentos, e compará-los, de maneira crítica, em prol da obtenção da pré-qualificação de medicamentos. A metodologia empregada promoveu uma abordagem abrangente acerca das regulamentações nacionais e dos guias da OMS, por intermédio da seguinte técnica de coleta de dados: pesquisa bibliográfica e documental. O presente trabalho possibilitou evidenciar um alto grau de harmonização acerca dos tópicos/subtópicos comparados entre os guias da OMS e a normatização nacional imposta pela Anvisa em BPF, o que demonstra uma inserção da legislação nacional no contexto internacional, corroborando o alinhamento entre a Anvisa e OMS, no tocante ao cumprimento das BPF

The drug Prequalification: comparative analysis between WHO Good Manufacturing Practice and ANVISA

Made available in DSpace on 2015-08-19T13:52:56Z (GMT). No. of bitstreams: 2 15.pdf: 2031861 bytes, checksum: 32edc08872af428837658b461b80f2a7 (MD5) license.txt: 1748 bytes, checksum: 8a4605be74aa9ea9d79846c1fba20a33 (MD5) Previous issue date: 2014Fundação Oswaldo Cruz. Instituto de Tecnologia em Fármacos/Farmanguinhos. Rio de Janeiro, RJ, Brasil.A produção de medicamentos com qualidade, segurança, eficácia é fundamental para atender às demandas nacionais e internacionais, com o fito de subsidiar a assistência farmacêutica no âmbito da saúde pública. Diante do papel estratégico em que o complexo fabril público de saúde está inserido, caracterizado pela necessidade de produção de medicamentos destinados ao tratamento de doenças negligenciadas, a Gestão da Qualidade dentro de um Laboratório Farmacêutico Oficial, fundamentada nas Boas Práticas de Fabricação e reconhecida pela Organização Mundial de Saúde é essencial para a exportação de seus medicamentos via organismos internacionais. No caso de Farmanguinhos/FIOCRUZ, maior laboratório de medicamentos da rede pública oficial, a busca pelo aprimoramento contínuo dos processos produtivos dos seus produtos, visa à obtenção de vantagens competitivas para a organização, por intermédio de sua entrada no mercado externo de medicamentos e destaque de sua posição estratégica no processo de cooperação internacional em saúde, expandindo o protagonismo da política externa nacional. Os objetivos deste trabalho foram identificar os principais requisitos técnicos recomendados pela Organização Mundial de Saúde e exigidos pela Agência Nacional de Vigilância Sanitária, para o cumprimento e reconhecimento das Boas Práticas de Fabricação de medicamentos, e compará-los, de maneira crítica, em prol da obtenção da pré-qualificação de medicamentos. Os elementos de análise escolhidos foram divididos em tópicos e subtópicos, estabelecendo-se tabelas comparativas entre aOrganização Mundial de Saúde e a Agência Nacional de Vigilância Sanitária. A metodologia empregada na pesquisa em questão é classificada como exploratória, uma vez que foi realizada uma abordagem abrangente acerca das regulamentações nacionais e dos guias da Organização Mundial de Saúde, por intermédio da seguinte técnica de coleta de dados: pesquisa bibliográfica e documental. Os resultados obtidos permitiram constatar o alinhamentoentre as recomendações da Organização Mundial de Saúde e as exigências da Agência Nacional de Vigilância Sanitária e, por conseguinte, concluir a inserção da legislação nacional no cenário internacional, no tocante as Boas Práticas de Fabricação de medicamentos.Em seguida, foram traçados os principais entraves, recomendações e as perspectivas a serem inseridas ou redirecionadas, para que este projeto atenda às necessidades de Farmanguinhos. Pretende-se, com a elaboração desta proposta, contribuir com a Gestão Institucional de Farmanguinhos, em destaque, capacitá-la para obter a pré-qualificação da Organização Mundial de Saúde, promover uma reflexão ampla e servir de referência no âmbito da produção pública de medicamentos, fornecendo recomendações para a qualificação do complexo fabril estatal nacional, em consonância com as exigências regulatórias específicas da Agência Nacional de Vigilância Sanitária e recomendações da Organização Mundial de Saúde.The Production of medicines with quality, safety, efficiency is essential to meet national and international requirements, aiming at subsidizing pharmaceutical care within the public health. Given the strategic role that public health industrial complex is inserted, characterized by the need to produce drugs for the treatment of neglected diseases, Quality Management within a Pharmaceutical Laboratory Officer, based on Good Manufacturing Practices and recognized by the World Health Organization is essential to export their drugs via international organizations. Farmaguinhos/ FIOCRUZ, the biggest laboratory at the public network, searches for continuous improvement of its production processes, aiming to obtain competitive advantages for the organization, through its entry in the foreign market of medicines and highlighted strategic position in international health cooperation process, expanding the role of national foreign policy. The objectives of this study were to identify the main technical requirements recommended by the World Health Organization and enforced by the Brazilian Health Surveillance Agency (ANVISA), for compliance and recognition of Good Manufacturing Practice for medicinal products and compare them critically, to obtain the prequalification of medicines. The elements chosen for analysis were divided into topics and subtopics, establishing comparative tables between the World Health Organization and ANVISA. The methodology used in the research is classified as exploratory, since a comprehensive approach on national regulations and the World Health Organization guidelines, through the following technical data collection, was performed: literature and documents. The results revealed the alignment between the recommendations of the World Health Organization and the requirements of ANVISA and therefore entering the national legislation in the international scenario with regard to Good Manufacturing Practice for medicinal products. Then we trace the main barriers, recommendations and perspectives to be inserted or redirected, so that this project meets the needs of Farmaguinhos. It is intended to contribute with the Institutional Management Farmaguinhos to obtain prequalification from the World Health Organization, to promote a broad reflection and serve as a reference under the public production medications, providing recommendations for the qualification of th e public factory complex, in line with the specific regulatory requirements of ANVISA and recommendations of the World Health Organization

Núcleos de Ensino da Unesp: artigos 2007

Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP)Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq

Brazilian Flora 2020: Leveraging the power of a collaborative scientific network

International audienceThe shortage of reliable primary taxonomic data limits the description of biological taxa and the understanding of biodiversity patterns and processes, complicating biogeographical, ecological, and evolutionary studies. This deficit creates a significant taxonomic impediment to biodiversity research and conservation planning. The taxonomic impediment and the biodiversity crisis are widely recognized, highlighting the urgent need for reliable taxonomic data. Over the past decade, numerous countries worldwide have devoted considerable effort to Target 1 of the Global Strategy for Plant Conservation (GSPC), which called for the preparation of a working list of all known plant species by 2010 and an online world Flora by 2020. Brazil is a megadiverse country, home to more of the world's known plant species than any other country. Despite that, Flora Brasiliensis, concluded in 1906, was the last comprehensive treatment of the Brazilian flora. The lack of accurate estimates of the number of species of algae, fungi, and plants occurring in Brazil contributes to the prevailing taxonomic impediment and delays progress towards the GSPC targets. Over the past 12 years, a legion of taxonomists motivated to meet Target 1 of the GSPC, worked together to gather and integrate knowledge on the algal, plant, and fungal diversity of Brazil. Overall, a team of about 980 taxonomists joined efforts in a highly collaborative project that used cybertaxonomy to prepare an updated Flora of Brazil, showing the power of scientific collaboration to reach ambitious goals. This paper presents an overview of the Brazilian Flora 2020 and provides taxonomic and spatial updates on the algae, fungi, and plants found in one of the world's most biodiverse countries. We further identify collection gaps and summarize future goals that extend beyond 2020. Our results show that Brazil is home to 46,975 native species of algae, fungi, and plants, of which 19,669 are endemic to the country. The data compiled to date suggests that the Atlantic Rainforest might be the most diverse Brazilian domain for all plant groups except gymnosperms, which are most diverse in the Amazon. However, scientific knowledge of Brazilian diversity is still unequally distributed, with the Atlantic Rainforest and the Cerrado being the most intensively sampled and studied biomes in the country. In times of “scientific reductionism”, with botanical and mycological sciences suffering pervasive depreciation in recent decades, the first online Flora of Brazil 2020 significantly enhanced the quality and quantity of taxonomic data available for algae, fungi, and plants from Brazil. This project also made all the information freely available online, providing a firm foundation for future research and for the management, conservation, and sustainable use of the Brazilian funga and flora

NEOTROPICAL ALIEN MAMMALS: a data set of occurrence and abundance of alien mammals in the Neotropics

Biological invasion is one of the main threats to native biodiversity. For a species to become invasive, it must be voluntarily or involuntarily introduced by humans into a nonnative habitat. Mammals were among first taxa to be introduced worldwide for game, meat, and labor, yet the number of species introduced in the Neotropics remains unknown. In this data set, we make available occurrence and abundance data on mammal species that (1) transposed a geographical barrier and (2) were voluntarily or involuntarily introduced by humans into the Neotropics. Our data set is composed of 73,738 historical and current georeferenced records on alien mammal species of which around 96% correspond to occurrence data on 77 species belonging to eight orders and 26 families. Data cover 26 continental countries in the Neotropics, ranging from Mexico and its frontier regions (southern Florida and coastal-central Florida in the southeast United States) to Argentina, Paraguay, Chile, and Uruguay, and the 13 countries of Caribbean islands. Our data set also includes neotropical species (e.g., Callithrix sp., Myocastor coypus, Nasua nasua) considered alien in particular areas of Neotropics. The most numerous species in terms of records are from Bos sp. (n = 37,782), Sus scrofa (n = 6,730), and Canis familiaris (n = 10,084); 17 species were represented by only one record (e.g., Syncerus caffer, Cervus timorensis, Cervus unicolor, Canis latrans). Primates have the highest number of species in the data set (n = 20 species), partly because of uncertainties regarding taxonomic identification of the genera Callithrix, which includes the species Callithrix aurita, Callithrix flaviceps, Callithrix geoffroyi, Callithrix jacchus, Callithrix kuhlii, Callithrix penicillata, and their hybrids. This unique data set will be a valuable source of information on invasion risk assessments, biodiversity redistribution and conservation-related research. There are no copyright restrictions. Please cite this data paper when using the data in publications. We also request that researchers and teachers inform us on how they are using the data