Submitted by Jean Medeiros (jeanletras@uepb.edu.br) on 2018-05-24T13:45:49Z No. of bitstreams: 1 PDF - Inácio Costa Neto.pdf: 37706583 bytes, checksum: 2e6b9e65c5857fc8eda45146b4f4d0bb (MD5) / Approved for entry into archive by Secta BC (secta.csu.bc@uepb.edu.br) on 2018-06-05T11:34:00Z (GMT) No. of bitstreams: 1 PDF - Inácio Costa Neto.pdf: 37706583 bytes, checksum: 2e6b9e65c5857fc8eda45146b4f4d0bb (MD5) / Made available in DSpace on 2018-06-05T11:34:00Z (GMT). No. of bitstreams: 1 PDF - Inácio Costa Neto.pdf: 37706583 bytes, checksum: 2e6b9e65c5857fc8eda45146b4f4d0bb (MD5) Previous issue date: 2017-04-17 / This work seeks to perform a mapping of the production process for Good Manufacturing Practices in Additive Manufacturing in the Laboratory of Three Dimensional Technologies of the Nucleus of Technology for Health of the State University of Paraíba based on chapter five of RDC 16/13, in order to Possible future preparation of a manual of good manufacturing practices of this laboratory. This is a theoretical work in order to guarantee methodologies to extract the maximum quality of the process in question, aiming to provide guarantees of reliability, reproducibility and predictability of the biomodels produced, through standards, manuals, methods and resolutions when manufacturing medical products Such as surgical guides, temporary or permanent prostheses and orthoses. This work is justified on the assumption that biomodels are already being manufactured, but that they do not follow the necessary method in order to optimize the manufacturing process, thus spending too much time and financial resources. With this, it was possible to guarantee that the process is carried out following a layout for the laboratory that will facilitate the manufacture of the biomodel, and the creation of a flow chart proper to good manufacturing practices, allowing each agent to have its own function. / Este trabalho busca realizar um mapeamento do processo de produção para as Boas Práticas de Fabricação em Manufatura Aditiva no Laboratório de Tecnologias Tridimensionais do Núcleo de Tecnologia para Saúde da Universidade Estadual da Paraíba baseando-se no capítulo cinco da RDC 16/13, a fim de possibilitar a futura elaboração de um manual de boas práticas de fabricação deste laboratório. Trata-se e um trabalho teórico a afim de garantir metodologias que permitam extrair a máxima qualidade do processo em questão, objetivando proporcionar garantias de fidedignidade, reprodutibilidade e previsibilidade dos biomodelos produzidos, por meio de normas, manuais, métodos e resoluções ao fabricar produtos médicos específicos como guias cirúrgicos, próteses provisórias ou permanentes e órteses. Justifica -se esse trabalho a partir do pressuposto que já existem biomodelos sendo fabricados, mas que não seguem o método necessário a fim de avalizar a fabricação de maneira otimizada, gastando assim tempo e recursos financeiros em demasia. Com isso, foi possível garantir que o processo seja realizado seguindo um layout para o laboratório que facilitará a manufatura do biomodelo, e a criação de um fluxograma próprio para as boas práticas de fabricação, permitindo que cada agente tenha sua própria função.

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.