Masters of Science / The aim of this study was to develop a Stock Control Assessment Tool for use in the public health care sector and then to apply it to identify problems in the stock control system. This would help authorities to optimize the system. The advantages experienced with such a dynamic Assessment Tool were many: The Tool was quick and easy to apply; it was user friendly; it provided an immediate SWOT analysis of a particular facility; it is in line with the SA NDP directives and it provides an indication of which structures are in place and whether they are functioning properly. Furthermore; it could determine the increase or decrease in performance of a facility (therefore identify trends within the functional status of a system) when data is collected over a period of time; and finally, it could also be used to prioritize drug policy directives. The following steps were established in the development of the Tool: A literature review of pharmaceutical stock control and Drug Supply Management was addressed to provide the background information for the motivation of this study and to identify the various elements that could influence stock control at a facility level. Observational studies were applied at selected private and public facilities to observe the impact of these identified stock control elements. An 'ideal' stock control system was then generated from the literature review and observational assessment. A structured questionnaire was developed and surveyed at these facilities to generate key areas of concern of a stock control system. A study and adaptation of the indicator methods used by the World Health Organization (WHO) to monitor drug use in health facilities resulted in the formulation of a practical Stock Control Assessment Tool based on 11 key indicators and a number of sub-indicators, all of which were objectively defined. The Tool was then applied at selected public facilities and the results were analyzed quantitatively, qualitatively and subjectively. Each of the indicators was then applied and results examined closely with a view to possible refinements of the indicator. The refinements were made and the Tool was re-applied at two selected facilities. These two facilities were randomly selected from the original six facilities included for the testing of the Tool. Final conclusions and specific recommendations were generated to improve the stock control systems at the selected public health care facilities.

[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.