In drug, medical, and consumer products businesses, leaders should establish strategies that ensure production of quality products and drive profitability. Sales of defective or substandard products carry a potential risk of unintended effects on the consumer. The purpose of this single case study was to explore the strategies used by leaders to influence a culture of quality and compliance, leading to production of saleable products, and business profitability. The conceptual framework of the theory of constraints served to guide the scope and data analysis for this study. Participants included ten individuals with a minimum of 5 years of experience at the study company, based in the northeast region of the U.S., in director, manager, and technical leader roles who participated in individual, telephone-based interviews. Additional data sources for methodological triangulation included observations during a tour of the headquarters site, and analysis of policies, procedures, annual reports, and publicly available information. Data analysis included coding of the data and analysis to identify themes and patterns that identify the strategies leaders use to embed a culture of quality. The emergent themes in this study included: leadership, culture and habits, communications, and management systems and data analysis. The findings of this study may contribute to positive social change and improved business practice by providing tools and skills needed by business leaders to ensure product quality and business success. By consistently delivering quality products to the market, the organization builds a sustainable business where the community can benefit from a stable supply of jobs and the consumer from a reliable supply of products that safely meet customer needs.

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior / Rupatadine is a second generation antihistamine H1, from the pyperidinic group, which inhibits both the histamine and platelet activating factor effects, and is clinically used for the treatment of allergic rhinitis and chronic urticaria. The methods for the evaluation of rupatadine in pharmaceutical products were developed and validated in the present work. The reversed-phase liquid chromatography (RP-LC) analysis was carried out using a Gemini C18 column (150 mm x 4.6 mm), maintained at 30 oC. The mobile phase consisted of ammonium acetate buffer 0.01 M, pH 3.0 with 0.05% of 1-heptanosulfonic acid/acetonitrile (71.5:28.5 v/v), run at a flow rate of 1.0 mL/min with detection at 242 nm. The chromatographic separation was obtained within 7 min and it was linear in the concentration range of 0.5-400 μg/mL (r2=0.9999). The capillary electrophoresis method was developed and validated, using the micellar electrokinetic chromatography (MEKC) as the separation mode, and nimesulide as internal standard (IS). The analysis were performed on a fused-silica capillary (50 μm id, effective length, 40 cm), maintained at 35ºC, using electrolyte solution consisted of 15 mM borate buffer and 25 mM anionic detergent SDS solution at pH 10, with detection by photodiode array detector set at 205 nm. The injection was performed using the hydrodynamic mode at 50 mbar for 5 s, and a constant voltage of 25 kV was applied during the analysis. The electrophoretic separation was obtained within 6 min and it was linear in the oncentration range of 0.5-150 μg/mL (r2=0.9996). The procedures were validated evaluating parameters such as the specificity, linearity, precision, accuracy, limits of detection and quantitation, robustness, and system suitability test, giving results within the acceptable range. The proposed methods were applied for the analysis of pharmaceutical products, showing significant correlation (P>0.05) of the results. Therefore, the procedures can be applied to improve the quality control of pharmaceutical products and to assure the safety and therapeutic efficacy of the drug. / A rupatadina é um anti-histamínico H1 de segunda geração pertencente ao grupo piperidínico, que inibe os efeitos da histamina e do fator ativador plaquetário, sendo utilizada clinicamente no tratamento de rinite alérgica e urticária crônica. No presente trabalho foram desenvolvidos e validados métodos para avaliação de rupatadina em produtos farmacêuticos. As análises por cromatografia líquida em fase reversa (CL-FR) foram realizadas utilizando coluna Gemini C18 (150 mm x 4,6 mm), mantida a 30 oC. A fase móvel foi composta de tampão acetato de amônio 0,01 M, pH 3,0 com 0,05% de ácido 1-heptanosulfônico/acetonitrila (71,5:28,5, v/v), eluída na vazão de 1,0 mL/min com detecção no ultravioleta a 242 nm. A separação cromatográfica foi obtida no tempo de 7 min, sendo linear na faixa de concentração de 0,5-400 μg/mL (r2=0,9999). Paralelamente, desenvolveu-se e validou-se método por eletroforese capilar, utilizando modo de separação por cromatografia eletrocinética micelar (MEKC) e nimesulida como padrão interno (PI). Executaram-se as análises em capilar de sílica fundida (50 μm id, comprimento efetivo de 40 cm), mantido a 35ºC, utilizando solução eletrolítica composta de tampão borato 15 mM e tensoativo aniônico SDS 25 mM, pH 10, com detecção no ultravioleta a 205 nm. A injeção foi realizada no modo hidrodinâmico a 50 mbar durante 5 s e voltagem constante de 25 kV foi aplicada durante as análises. A separação eletroforética foi obtida em 6 min, sendo linear na faixa de concentração de 0,5-150 μg/mL (r2=0,9996). Os procedimentos foram validados, avaliando-se os parâmetros de especificidade, linearidade, precisão, exatidão, limite de detecção e quantificação, robustez e teste de adequabilidade do sistema, cujos resultados cumpriram os requisitos preconizados. Os métodos propostos foram aplicados na análise de produtos farmacêuticos, demonstrando correlação significativa dos resultados (P>0,05). Desse modo, estabeleceram-se procedimentos que podem ser aplicados para aprimorar o controle da qualidade de medicamentos, bem como garantir a segurança e eficácia no uso terapêutico.

Etoricoxib is a non-steroidal anti-inflammatory drug, from the coxibs group, that represents a second-generation of COX-2 inhibitors, used for the treatment of arthritis and pain. The methodologies for the evaluation of etoricoxib in pharmaceutical products and plasma were developed and validated in the present work. The reversed-phase liquid chromatography (RP-LC) analysis was carried out using a Synergi fusion C18 column (150 mm x 4.6 mm), maintained at a controlled-ambient temperature. The mobile phase consisted of phosphoric acid 0.01 M, pH 3.0/acetonitrile (62:38, V/V), run at a flow rate of 1.0 mL/min with detection at 234 nm. The chromatographic separation was obtained within 7.0 min and it was linear in the concentration range of 0.02-150 µg/mL. The liquid chromatography-tandem mass spectrometry (LC-MS/MS) method was developed and validated using a Luna C18 column (50 mm x 3.0 mm), maintained at 40 ºC and the mobile phase consisted of acetonitrile:water (95:5, V/V)/ 0.1% acetic acid (90:10, V/V), run at flow rate of 0.4 mL/min. The mass spectrometer, equipped with electrospray positive source, was used in multiple reaction monitoring mode (MRM), monitoring the transitions of 359.3>280.0 and 332.0>95.0, for etoricoxib and piroxicam (internal standard), respectively. The chromatographic separation was obtained within 2.0 min and it was linear in the concentration range of 1-5000 ng/mL. The procedures were validated evaluating parameters such as the specificity, linearity, precision, accuracy, robustness, limit of detection and limit of quantitation. Besides, for the bioanalytical method, the matrix effects, recovery and stability studies were also analyzed, giving results within the acceptable range. The proposed methods were applied for the analysis of pharmaceutical products, showing significant correlation (r=0.9999) of the results. Moreover, the liquid-liquid and solid phase extraction methods developed and optimized allowed high mean recoveries of etoricoxib and internal standard from the plasma samples. The procedures can be applied for the biovailability studies and for the quality control of pharmaceutical products. / Etoricoxibe é um antiinflamatório não esteroidal, pertencente ao grupo dos coxibes, que representa a segunda geração dos inibidores seletivos da cicloxigenase-2. É indicado para o tratamento de artrites e dor aguda. No presente trabalho foram desenvolvidas e validadas metodologias para avaliação de etoricoxibe em produtos farmacêuticos e plasma humano. As análises por cromatografia líquida em fase reversa (CL-FR) foram realizadas utilizando coluna Synergi fusion C18 (150 mm x 4,6 mm), mantida a temperatura ambiente. A fase móvel foi composta de ácido fosfórico 0,01 M, pH 3,0/acetonitrila (62:38, V/V) na vazão de 1,0 mL/min e detecção no ultravioleta a 234 nm. A separação cromatográfica foi obtida no tempo de 7 minutos, sendo linear na faixa de concentração de 0,02-150 µg/mL. Paralelamente, desenvolveu-se e validou-se método por cromatografia líquida combinada à espectrometria de massas (CL-EM/EM). Realizaram-se as análises utilizando Luna C18 (50 mm x 4,6 mm), mantida a 40 ºC e fase móvel composta de acetonitrila:água (95:5, V/V)/ 0,1% ácido acético (90:10, V/V), na vazão de 0,4 mL/min. O espectrômetro de massas, equipado com fonte de electrospray positivo, foi empregado no modo de monitoramento de reação múltipla (MRM), monitorando as transições de 359,3>280,0 e 332,0>95,0, para o etoricoxibe e piroxicam (padrão interno), respectivamente. A separação cromatográfica foi obtida em 2 minutos, sendo linear na faixa de concentração de 1-5000 ng/mL. Os procedimentos foram validados, avaliando-se os parâmetros de especificidade, linearidade, precisão, exatidão, robustez, limite de detecção e quantificação, incluindo para o método bioanalítico os efeitos de matriz, a recuperação e estudos de estabilidade, cujos resultados cumpriram os requisitos preconizados. Os métodos propostos foram utilizados na análise de produtos farmacêuticos, demonstrando correlação significativa dos resultados (r=0,9999). Além disso, os métodos de extração líquido-líquido e em fase sólida desenvolvidos e otimizados propiciaram significativas percentagens de recuperação do etoricoxibe e do padrão interno nas amostras de plasma. Os procedimentos pesquisados podem ser aplicados para estudos de biodisponibilidade e para aprimorar o controle da qualidade de medicamentos.

Ezetimibe selectively inhibits the intestinal absorption of dietary cholesterol and related plant sterols, from the 2-azetidinones group, and is used for the treatment of hypercholesterolemia and phytosterolemia. The methodologies for the evaluation of ezetimibe in pharmaceutical products and plasma were developed and validated in the present work. The reversed-phase liquid chromatography (RP-LC) analysis was carried out using a Synergi fusion C18 column (150 mm x 4.6 mm), maintained at 45 oC. The mobile phase consisted of potassium phosphate buffer 0.03 M, pH 4.5/acetonitrile (35:65, V/V), run at a flow rate of 0.6 mL/min with detection at 234 nm. The chromatographic separation was obtained within 15 min and it was linear in the concentration range of 0.5-200 Hg/mL. The method was sucessfuly applied for the simultaneous determination of ezetimibe and simvastatin in pharmaceutical products. The liquid chromatography-tandem mass spectrometry (LCMS/ MS) method was developed and validated using a Luna C18 column (50 mm x 3.0 mm) and the mobile phase consisted of acetonitrile:water (85:15, V/V), run at a flow rate of 0.4 mL/min. The mass spectrometer, equipped with electrospray positive source, was used in multiple reaction monitoring mode (MRM), monitoring the transitions of 392.0>161.0 and 359.3>280.0, for ezetimibe and etoricoxib (internal standard), respectively. The chromatographic separation was obtained within 2 min and it was linear in the concentration range of 0.25-20 ng/mL (ezetimibe) and 1-300 ng/mL (ezetimibe and its glucuronide matabolite). The procedures were validated evaluating parameters such as the specificity, linearity, precision, accuracy, robustness, limit of detection and limit of quantitation. Besides, for the bioanalytical method, the matrix effects, recovery and stability studies were also analyzed, giving results within the acceptable range. The proposed method was applied for the analysis of pharmaceutical products, showing significant correlation (P>0.05) of the results. Moreover, the liquid-liquid extraction method developed and optimized allowed high mean recoveries of ezetimibe and internal standard from the plasma samples. The procedures can be applied for the biovailability studies and for the quality control of pharmaceutical products. / Ezetimiba é um inibidor seletivo da absorção intestinal do colesterol e de fitosteróis, pertencente ao grupo das 2-ezetidinonas, indicado para o tratamento da hipercolesterolemia e fitosterolemia. No presente trabalho foram desenvolvidas e validadas metodologias para avaliação de ezetimiba em produtos farmacêuticos e plasma humano. As análises por cromatografia líquida em fase reversa (CL-FR) foram realizadas utilizando coluna Synergi fusion C18 (150 mm x 4,6 mm), mantida a 45 oC. A fase móvel foi composta de tampão fosfato de potássio 0,03 M, pH 4,5/acetonitrila (35:65, V/V), eluída na vazão de 0,6 mL/min e detecção no ultravioleta a 234 nm. A separação cromatográfica foi obtida no tempo de 15 minutos, sendo linear na faixa de concentração de 0,5-200 Hg/mL. O método foi aplicado para análise simultânea de ezetimiba e sinvastatina em produtos farmacêuticos comerciais. Paralelamente, desenvolveu-se e validou-se método por cromatografia líquida combinada à espectrometria de massas (CL-EM/EM). Executaram-se as análises utilizando coluna Luna C18 (50 mm x 4,6 mm) e fase móvel composta de acetonitrila:água (85:15, V/V) na vazão de 0,4 mL/min. O espectrômetro de massas, equipado com fonte de electrospray positivo, foi empregado no modo de monitoramento de reação múltipla (MRM), monitorando as transições de 392,0>161,0 e 359,3>280,0, para a ezetimiba e etoricoxibe (padrão interno), respectivamente. A separação cromatográfica foi obtida em 2 minutos, sendo linear nas faixas de concentração de 0,25-20 ng/mL (ezetimiba) e 1-300 ng/mL (ezetimiba e seu metabólito). Os procedimentos foram validados, avaliando-se os parâmetros de especificidade, linearidade, precisão, exatidão, robustez, limite de detecção e quantificação, incluindo para o método bioanalítico os efeitos de matriz, recuperação e estudos de estabilidade, cujos resultados cumpriram os requisitos preconizados. O método proposto foi utilizado na análise de produtos farmacêuticos, demonstrando correlação significativa dos resultados (P>0,05). Além disso, o método de extração líquido-líquido desenvolvido e otimizado propiciou significativa percentagem de recuperação da ezetimiba, seu metabólito e do padrão interno nas amostras de plasma. Os procedimentos pesquisados podem ser aplicados para estudos de biodisponibilidade e para aprimorar o controle da qualidade de medicamentos.

The Graduation thesis concerns with the topic of the transport of supplier -- customer operations in the pharmaceutical group Zentiva. At first the thesis describes in detail the legislative arrangement for the pharmaceutical group not only in the Czech Republic but also in the European Union. The reader gets the conception of the processing in the Purchasing department in the pharmaceutical company and also of the transport of raw materials to the production plants. Another part is dealing with the the distribution of pharmaceutical products (medicaments) to the several regions, where Zentiva is distributing its products. The most current and interesting subject matter in these days newly introduced distribution of consolidated products of Zentiva and Sanofi-aventis from the production plants to the several pharmacies in the Czech Republic. Sanofi-aventis ordered this new way of distribution to Zentiva, as Sanofi-aventis is the majority shareholder of Zentiva from the spring of 2009. The direct distribution of pharmaceutical products from the producer to pharmacies is very specific. Zentiva is not only the first pharmaceutical company in the Czech Republic but also one of the firsts companies in Europe, which will carry out this type of distribution beginning January 2010.

This study is aimed at analyzing the effectiveness of state intervention in the form of pharmaceutical external price referencing (EPR) in selected EU countries, as well as the description of drug policy and EPR in the analyzed countries. Among the analyzed countries, the United Kingdom and Sweden have been selected as representatives who don't use EPR regulation. On the other hand, the Czech Republic, Hungary, Austria, Spain and the Netherlands are countries that regulate using EPR. The prices of selected pharmaceutical products in all of those states are converted into producer prices, on which most countries concentrate EPR. Prices are analyzed after the conversion of nominal and real exchange rates. The lowest prices are found in the Netherlands and the UK. This proves that EPR doesn't bring lower prices for medicine in the countries which use it. Further rankings vary based on the exchange rates used. The paper also analyzes the achievement of price ceilings in the Czech Republic, where the maximum prices set by regulators of EPR (including VAT) are compared with the average prices in pharmacies. All analyzed medicinal product prices are below the ceilings, which also proves the ineffectiveness of this intervention.

En este trabajo de investigación se desarrollará el plan de negocios de Medifácil, una nueva empresa que busca ingresar al mercado de aplicaciones móviles con su metabuscador de productos farmacéuticos. La constante innovación tecnológica ha contribuido con el incremento de emprendimientos que se apoyan en la tecnología para brindar soluciones virtuales a las personas. Ese es el caso del sector farmacéutico, pues debido a la pandemia de la Covid-19, las farmacias y boticas han implementado o mejorado sus aplicaciones móviles y webs para atender la necesidad de adquirir medicamentos sin salir de casa. Sin embargo, si bien existen empresas de venta y reparto de medicinas en el mercado, estas presentan inconvenientes con respecto a la falta de stock, o el largo tiempo que les toma a los clientes comparar los precios entre farmacias. Por esa razón, Medifácil trae una propuesta que mitigará esos inconvenientes y mejorará la experiencia de búsqueda y compra de medicamentos. Así, en una sola aplicación se podrá buscar el medicamento requerido y el metabuscador listará las farmacias y boticas que cuenten con stock en tiempo real, para que se puedan comparar los precios y se elija la mejor opción para el consumidor. Medifácil se podrá descargar gratis en los mercados oficiales de Google y Apple, por lo que la principal fuente de ingresos provendrá de una comisión cobrada a cada farmacia y botica afiliada que concrete ventas gracias a la redirección del metabuscador. Inicialmente, la cobertura será en Lima Metropolitana y hasta 40 kilómetros alrededor, pero se proyecta ingresar a La Libertad y Arequipa luego en el tercer año de operación. Se requiere de un socio inversionista que aporte el 30% del capital equivalente a S/ 45,382. Este, servirá para cubrir todos los gastos de la puesta en marcha del negocio, y se recuperará en menos de dos años. / This research work will develop the business plan of Medifácil, a new company that seeks to enter the mobile applications market with its metasearch for pharmaceutical products. The constant technological innovation has contributed to the increase of ventures that rely on technology to provide virtual solutions to people. This is the case of the pharmaceutical sector, because due to the Covid-19 pandemic, pharmacies and drug stores have implemented or improved their mobile applications and websites to cover the need to purchase medicines without leaving home. However, although there are companies that sell and distribute medicines in the market, they have problems with regards to shortage of stock, or the long time it takes for customers to compare prices between pharmacies. For that reason, Medifácil brings a proposal that will mitigate these problems and improve the experience of searching and buying medicines. According to that, in a single application the required drug can be searched, and the metasearch will list the pharmacies and drugstores that have stock in real time, so that prices can be compared, and the costumer can choose the best option. Medifácil can be downloaded for free in the official Google and Apple markets, so the main source of income will come from a commission charged to each affiliated pharmacy and drugstore that makes sales thanks to the redirection of the metasearch. At the beginning, the coverage will be in Metropolitan Lima and up to 40 kilometers around, but it is planned to enter La Libertad and Arequipa in the third year of operation. An investor partner is required to contribute 30% of the capital equivalent to S / 45,382. This will be used to cover all the expenses of the start-up of the business and will be recovered in less than two years. / Trabajo de investigación

Los medicamentos cumplen un rol fundamental en la sociedad debido a que contribuyen a la salud de las personas gracias a sus componentes químicos. Es precisamente por su composición que, cuando se eliminan incorrectamente, estos productos podrían llegar a generar numerosos problemas debido a la toxicidad y contaminación por las sustancias químicas que contienen, representando un riesgo para la vida humana además de generar que la contaminación ambiental incremente. En ese sentido, el presente estudio se titula Análisis de la logística inversa en los importadores de la industria farmacéutica de la partida del sistema armonizado 30.03 en lima metropolitana durante el periodo 2015-2019 y tiene como objetivo: Comprender la aplicación de la logística inversa en las empresas importadoras de la industria farmacéutica de la partida del sistema armonizado 30.03 en Lima Metropolitana durante el periodo 2015-2019. Mediante un enfoque cualitativo se recolectó información de los actores involucrados como representantes de asociaciones, laboratorios importadores de la partida en cuestión y expertos en logística inversa mediante la realización de entrevistas. Gracias a ello, se obtuvo el resultado de que las empresas importadoras del sector farmacéutico sí emplean la logística inversa en sus procesos, mediante la correcta eliminación de los residuos. / Pharmaceutical products play a fundamental role in society because they contribute to people's health thanks to their chemical components. It is precisely because of their composition that, when improperly disposed of, these products could generate numerous problems due to toxicity and contamination by the chemical substances they contain, representing a risk to human life as well as increasing environmental pollution. In this sense, the present study is entitled Analysis of reverse logistics in importers of the pharmaceutical industry of the harmonized system item 30.03 in metropolitan lima during the period 2015-2019 and has the objective: To comprehend the application of reverse logistics in importing companies of the pharmaceutical industry of the harmonized system item 30.03 in Metropolitan Lima during the period 2015-2019. Using a qualitative approach, information was collected from key stakeholders such as representatives of associations, importing laboratories and experts in reverse logistics through interviews. As a result, it was found that importing companies in the pharmaceutical sector do use reverse logistics in their processes, through the correct disposal of waste. / Tesis

"Zimbabwe and South Africa are facing an HIV/AIDS epidemic of such proportions that the populations of these countries will markedly decline in the next ten years despite the existence of effective drugs to treat the symptoms of AIDS and dramatically lower the communicability of the virus. These drugs are under patent protection by companies in the developed world and the patents raise the prices above the level of affordability for HIV infected persons in South Africa and Zimbabwe. Zimbabwe has declared a national emergency on HIV/AIDS, apparently in conformance with TRIPS and has issued compulsory licenses to a local company that has started to manufacture and sell cheap anti-retroviral drugs. South Africa has not declared a national emergency and has not invoked the TRIPS flexibilities or utilized flexibilities inherent in its own legislation. However, while thousands of people die every week in the two countries, neither government has yet provided an effective HIV/AIDS policy. Extensive litigation and public pressure in South Africa has led the government to announce a policy of supplying free HIV drugs in public hospitals while the Zimbabwean government has announced the provision of the same drugs, also in public hospitals, apparently utilising the state of emergency. The TRIPS agreement under which the two governments undertook to protect international patents allows compulsory licensing under certain circumstances (not limited to a national emergency) and the Doha Declaration on TRIPS and Public Health, and subsequent agreements by the Ministerial Council of the WTO allow the manufacture and, in limited circumstances, the parallel importation of generic drugs. These provisions provide a theoretical mechanism for poor countries to ensure their citizens' rights of access to health (care). The research is aimed at identifying the extent of the effectiveness of the legal norms created by Articles 20 and 31 of TRIPS, the Doha Declaration and subsequent Council of Ministers' decisions, which together ostensibly provide a framework to allow provision of generic drugs. It is further aimed at investigating how the state of emergency in Zimbabwe has been utilised to provide cheap generic drugs to Zimbabweans and whether this would be an option for South Africa. A comparison of the legal provisions governing the provision of drugs in the two countries will also be undertaken to examine the extent to which international and national constitutional and legal provisions may be utilised to give effect to the right to health." -- Introduction. / Thesis (LLM (Human Rights and Democratisation in Africa)) -- University of Pretoria, 2004. / Prepared under the supervision of Dr. Enid Hill at the American University in Cairo. / http://www.chr.up.ac.za/academic_pro/llm1/dissertations.html / Centre for Human Rights / LLM

[pt] vO objetivo da dissertação é propor um modelo de autoavaliação para empresas farmacêuticas no Brasil, que possa ser utilizado para verificar sua capacidade em relação ao cumprimento das diretrizes e requisitos das Boas Práticas de Fabricação (BPF) de Medicamentos no Brasil, segundo a RDC número 301/2019 da Anvisa. Busca-se demonstrar a aplicabilidade do modelo mediante o desenvolvimento de um estudo empírico em uma empresa farmacêutica selecionada para este propósito. A pesquisa pode ser considerada aplicada, descritiva e metodológica. Quanto aos meios de investigação, a metodologia compreende: (i) pesquisa bibliográfica e análise documental sobre os temas centrais da pesquisa; (ii) construção da estrutura analítica hierárquica em alinhamento aos requisitos e itens da RDC número 301/2019 da Anvisa; (iii) aplicação do método Analytic Hierarchy Process (AHP) para definição dos pesos dos requisitos e itens da RDC número 301/2019; (iv) definição e aplicação do instrumento de autoavaliação junto ao Gerente Industrial da empresa selecionada para o estudo empírico e apuração do nível da capacidade da empresa quanto ao cumprimento de cada requisito/item da RDC número 301/2019; e (v) emprego do método Importance-Performance Analysis (IPA) para identificação dos requisitos/itens que devam ser priorizados em um plano de ação, visando a obtenção do certificado de BPF de medicamentos pela Anvisa. Destaca-se como resultado principal desta dissertação uma sistemática inovadora de autoavaliação de empresas farmacêuticas, na perspectiva de apoiar processos decisórios referentes à certificação dessas empresas segundo a RDC número 301/2019 da Anvisa. / [en] The dissertation aims to propose a self-assessment model for pharmaceutical firms that can verify their capacity to meet the requirements established in the Anvisa RDC n. 301/2019, concerned with the Good Manufacturing Practices for Pharmaceutical Products. It seeks to demonstrate the model s applicability by developing an empirical study in a pharmaceutical company selected for this purpose. The methodology comprises: (i) literature review and documentary analysis on the central research themes; (ii) definition of the analytical structure based on the Analytic Hierarchy Process (AHP) method, aligned with Good Manufacturing Practices (GMP) for Pharmaceutical Products; (iii) application of the AHP method for assigning weights to the requirements of Anvisa RDC n. 301/2019; (iv) application of the self-assessment instrument addressed to the Industrial Manager of the mentioned pharmaceutical firm and determination of its capacity level to meet each requirement/item of the RDC; and (v) employment of the Importance-Performance Analysis (IPA) method to identify requirements that should be prioritized aiming future certification by Anvisa. An innovative self-assessment model based on Good Manufacturing Practices for Pharmaceutical Products stands out as the main result of this dissertation. It can support decision-making processes related to the certification of pharmaceutical firms by Anvisa.