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Rozprawy doktorskie na temat „GMP (good manufacturing practice)”

Autor: Grafiati

Data publikacji: 3 czerwca 2025

Data aktualizacji: 31 lipca 2025

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1

Schüler, Susanne. "Qualitätskontrolle von Blutkomponenten nach GMP ("Good Manufacturing Practice")." [S.l.] : [s.n.], 2000. http://deposit.ddb.de/cgi-bin/dokserv?idn=95979025X.

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Schüler, Susanne. "Qualitätskontrolle von Blutkomponenten nach GMP ("Good Manufacturing Practice")." Doctoral thesis, Humboldt-Universität zu Berlin, Medizinische Fakultät - Universitätsklinikum Charité, 2000. http://dx.doi.org/10.18452/14490.

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Um die Qualität von Blutprodukten nach GMP zu überprüfen, wurden 72 Blutspenden bzw. ihre Folgeprodukte Erythrozytenkonzentrat in PAGGS-M, gefiltertes Erythrozytenkonzentrat und Fresh Frozen Plasma untersucht. Zusätzlich wurden an jeweils 12 Blutderivaten, die z.T. nicht zum Routineprogramm des Blutspendedienstes der Abteilung für Klinische Hämostaseologie und Transfusionsmedizin in Homburg/Saar gehören, Messungen durchgeführt, um ihre Qualität am Herstellungstag und am Ende der Haltbarkeit zu bestimmen. Als letztes wurden schließlich auch rheologische Parameter an 21 Erythrozytenkonzentraten

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Schüler, Susanne [Verfasser], E. [Gutachter] Morgenstern, F. [Gutachter] Jung, and H. [Gutachter] Kiesewetter. "Qualitätskontrolle von Blutkomponenten nach GMP ("Good Manufacturing Practice") / Susanne Schüler ; Gutachter: E. Morgenstern, F. Jung, H. Kiesewetter." Berlin : Humboldt-Universität zu Berlin, 2000. http://d-nb.info/1207669490/34.

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Velasquez, Sarah Elspeth. "The adoption of good manufacturing practices in grain elevators." Thesis, Manhattan, Kan. : Kansas State University, 2007. http://hdl.handle.net/2097/463.

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Yakob, Olsson Benjamin, and Homam Zraki. "Utformning och framtagning av en organisationsförändring : En fallstudie på Astra Zeneca." Thesis, Södertörns högskola, Företagsekonomi, 2017. http://urn.kb.se/resolve?urn=urn:nbn:se:sh:diva-33214.

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Läkemedelsindustrin är en starkt reglerad industri där all tillverkning av läkemedel måste utföras efter regler och riktlinjer som går under benämning Good Manufacturing Practice, GMP. Dessa riktlinjer är avsedda för att minimera alla risker som finns och uppkommer med farmaceutisk tillverkning. Astra Zenecas tillverkningsenhet i Södertälje tillverkar mer än 30 olika läkemedel till fler än 100 marknader. Detta har lett till att denna tillverkningsenhet ständigt är uppvaktad av inspektioner från olika marknader och myndigheter, för att försäkra att all tillverkning av läkemedel genomdrivs utifr

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Costa, Neto Inácio. "Elaboração de um mapeamento de boas práticas de fabricação para manufatura aditiva no laboratório de tecnologias 3D do núcleo de tecnologias estratégicas em saúde da UEPB." Universidade Estadual da Paraíba, 2017. http://tede.bc.uepb.edu.br/jspui/handle/tede/3074.

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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)<br>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)<br>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 issu

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Machado, Maluza. "Adaptação de um checklist de boas práticas de fabricação para agroindústrias familiares com potencial de adesão ao SUSAF-RS." reponame:Biblioteca Digital de Teses e Dissertações da UFRGS, 2017. http://hdl.handle.net/10183/174515.

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Este projeto tem por objetivo desenvolver um checklist de boas práticas de fabricação (BPF) adaptado ao público das agroindústrias familiares de pequeno porte (AFPP) produtoras de embutidos, de modo que sirva como ferramenta de auxílio na recomendação das AFPP ao SUSAF-RS (Sistema Estadual Unificado de Sanidade Agroindustrial Familiar e de Pequeno Porte do RS). Foram visitadas 20 agroindústrias situadas nas regionais da Emater de Lajeado e Soledade, onde foi aplicado o checklist de BPF original (BRASIL, 2002) bem como o checklist adaptado desenvolvido. As agroindústrias foram classificadas em

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Antoni, Carlotta. "La Validazione GAMP5 di macchine automatiche per il settore farmaceutico: proposte migliorative." Master's thesis, Alma Mater Studiorum - Università di Bologna, 2021.

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Il settore farmaceutico è regolato da una serie di norme atte a garantire un elevato livello di qualità del prodotto, per salvaguardare la salute degli utilizzatori. Il rispetto di tali norme deve essere dimostrato attraverso l'attività di validazione, ed è obbligatorio per la commercializzazione dei farmaci. Le GMP, Good Manufacturing Practice sono l'insieme delle norme che regolano la produzione di prodotti farmaceutici. Vista la complessità delle GMP, le case farmaceutiche possono usufruire delle GAMP, Good Automated Manufacturing Practice, un insieme linee guida che forniscono indicazioni

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Mavumengwana, Bongeka Nomakhephu. "The evaluation of a handheld Raman Analyser for the good laboratory practise (glp) compliant identification of paracetamol raw materials, in a pharmaceutical manufacturing environment." Thesis, Nelson Mandela Metropolitan University, 2015. http://hdl.handle.net/10948/4243.

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The use of a handheld Raman analyser for the positive identification of raw materials in a manufacturing pharmaceutical company was evaluated using paracetamol as test raw material to evaluate whether such a system would meet Aspen’s regulatory requirements. The approach involved subjecting the chosen raw material to identification tests under a variety of conditions so as to evaluate robustness, and specificity of the system. Thus, raw material provided by different suppliers, different packages of one manufacturing batch, and raw materials subjected to different storage conditions were evalu

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Polchow, Bianca [Verfasser]. "Cryopreservation of human vascular umbilical cord cells under good manufacturing practice conditions for future cell banks / Bianca Polchow." Berlin : Medizinische Fakultät Charité - Universitätsmedizin Berlin, 2015. http://d-nb.info/1075757460/34.

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Zanette, Camila. "Estudo da produção do radiofármaco FLT-18F em sistema automatizado: contribuição para a avaliação do processo." Universidade de São Paulo, 2013. http://www.teses.usp.br/teses/disponiveis/85/85131/tde-04072013-140325/.

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O radiofármaco FLT-18F é um análogo do nucleosídeo timidina e um promissor marcador da proliferação tumoral para imagens em PET. A síntese deste radiofármaco não é simples e, muitas vezes, apresenta baixos rendimentos. Este radiofármaco já vem sendo estudado há alguns anos, porém, não há produção, nem estudos clínicos, no Brasil. O estudo do processo produtivo e a sua adequação às diretrizes de Boas Práticas de Fabricação (ANVISA) são de extrema importância. Este trabalho teve como objetivo estudar a síntese deste radiofármaco, avaliar os métodos de controle de qualidade que serão utilizados n

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Authier, Jean Philippe. "Etude comparative des éditions de 1977 et 1983 de la partie du guide anglais "Guide to good pharmaceutical manufacturing practice" concernant les préparations stériles." Paris 5, 1988. http://www.theses.fr/1988PA05P055.

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Sequeira, Susana Anjos. "Preparation and handling of investigational medicinal products." Master's thesis, Universidade de Aveiro, 2013. http://hdl.handle.net/10773/12556.

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Mestrado em Biomedicina Farmacêutica<br>Duo to all of the challenges related with the production and logistics of the investigational medicinal products, this project aims to make an overview about the development of an investigational medicinal product, and the main details that must be considered in the preparation, packaging, labelling and distribution of investigational medicinal products, in order to provide a quick reference tool in a professional and academic context. A review was made in the international literature to identify studies focusing on development and handling of investig

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14

Krčálová, Jana. "Řízení jakosti a řízení reklamací ve společnosti." Master's thesis, Vysoké učení technické v Brně. Fakulta podnikatelská, 2010. http://www.nusl.cz/ntk/nusl-222737.

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This masters thesis deals with the current state of quality control system and control of complaints. Based on the information obtained from the analysis of the current situation in the company there is proposal of options and methods for quality improvements and control of complaints in the distribution process.

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Nowakowska, Paulina [Verfasser], Beatrix [Akademischer Betreuer] Süß, Adam [Akademischer Betreuer] Bertl, and Torsten [Akademischer Betreuer] Tonn. "Establishment of a good manufacturing practice-compliant procedure for expansion of therapeutic doses of genetically modified, CAR expressing NK-92 cells for the treatment of ErbB2-positive malignancies / Paulina Nowakowska ; Beatrix Süß, Adam Bertl, Torsten Tonn." Darmstadt : Universitäts- und Landesbibliothek Darmstadt, 2016. http://d-nb.info/1121781799/34.

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Abreu, Rafael Almeida Ferreira de. "O capital humano e a segurança dos alimentos: um olhar humanista na prática da alimentação coletiva." Universidade de São Paulo, 2015. http://www.teses.usp.br/teses/disponiveis/10/10134/tde-29012016-103142/.

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O presente estudo teve por objetivos: 1) caracterizar o Perfil Socioeconômico dos colaboradores; 2) caracterizar o Clima Organizacional; 3) caracterizar Comprometimento Organizacional; e 4) caracterizar e mapear o comportamento organizacional e verificar suas influencias no cumprimento da Boas Práticas de Higiene e Manipulação dos Alimentos. Refere-se a um estudo de caso com enfoque participativo utilizando-se de entrevistas, por se tratar de uma pesquisa essencialmente qualitativa. Concluiram-se que: 1) a valorização profissional, as relações interpessoais, os benefícios e políticas de incent

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FERREIRA, Ilvana Abreu de Sousa. "Riscos à segurança alimentar e nutricional: percepções de manipuladores de panificadoras." Universidade Federal de Goiás, 2012. http://repositorio.bc.ufg.br/tede/handle/tde/1480.

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Made available in DSpace on 2014-07-29T15:23:45Z (GMT). No. of bitstreams: 1 Ilvana Abreu de Sousa Ferreira.pdf: 855420 bytes, checksum: 3624d867c3296af7517eb133b20189c0 (MD5) Previous issue date: 2012-05-30<br>The concept of food security and nutrition was limited to supply the appropriate amount. However, it was extended also incorporating universal access to food, the nutritional aspect and therefore the issues of composition, quality and biological utilization. This security should be discussed, also because of the risks to health caused by food, since the Foodborne Diseases are graduall

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Pokorná, Klára. "Systém procesních auditů v oblasti zdravotnického průmyslu." Master's thesis, Vysoké učení technické v Brně. Fakulta podnikatelská, 2010. http://www.nusl.cz/ntk/nusl-222735.

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The Master’s thesis deals with the area of conducting process audits in a large multinational corporation focused on manufacturing and distribution of medical devices, which has a subsidiary in the Czech Republic. The thesis discusses the analysis of the current set up of the internal audits‘ system in the corporation and there are changes of the quality system being proposed on the basis of the analysis, whose aim is to achieve a full compliance with the requirements of the US administration FDA, the standard ISO 13485 as well as the recent requirements on performing process audits. The empha

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Schüler, Susanne [Verfasser]. "Qualitätskontrolle von Blutkomponenten nach GMP ("Good Manufacturing Practice") / von Susanne Schüler." 2000. http://d-nb.info/95979025X/34.

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Lian, Shwu-Hwa, and 連淑華. "A study on Good Manufacturing Practices (GMP) in Taiwan~ An Approach From Structure-Process-Outcome Aspects." Thesis, 1997. http://ndltd.ncl.edu.tw/handle/91351433569799944027.

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碩士<br>國立臺灣大學<br>公共衛生學系<br>85<br>ABSTRACT Unlike other general commodities, the quality of pharmaceutical product is ts is incapable to be justified only from their appearances. The poor qualitydifficult to identify by their appearance. While the poor quality of general of general merchandise may cause economic loss in general , worse than this ccommodities may cost economic loss in consumers, pharmaceutical products with ncern , the poor quality

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Nogueira, Ana Pascoal. "Relatórios de Estágio e Monografia intitulada “Procedimentos para obtenção de Certificação GMP”." Master's thesis, 2021. http://hdl.handle.net/10316/99081.

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Relatório de Estágio do Mestrado Integrado em Ciências Farmacêuticas apresentado à Faculdade de Farmácia<br>No presente documento existe uma breve descrição dos trabalhos que realizei ao longo dos estágios curriculares que tive oportunidade de fazer e a monografia que elaborei no âmbito da Unidade Curricular “Estágio” da Faculdade de Farmácia da Universidade de Coimbra. O documento está dividido em três partes. A primeira refere-se ao estágio na Farmácia Seixo, sob orientação do Dr. Faraj Barah. A segunda é relativa ao estágio que realizei na Bluepharma Industria Farmacêutica, S.A., no departa

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Wahyu, Fitrianto, and 樺宇. "Good Manufacturing Practices (GMP) Influence on Product Standard Compliance in Small and Medium Food Industry in Indonesia – Tofu Industry as an Example." Thesis, 2017. http://ndltd.ncl.edu.tw/handle/6f6a8x.

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碩士<br>國立交通大學<br>工業工程與管理系所<br>105<br>Food quality and safety have become important topic in food industry for decades. Good Manufacturing Practices (GMP) is developed as basic requirements to achieve food safety. Meanwhile, product standards are widely used as reference for product quality in global trading. Small and medium industry (SMI) with its natural limitations has more difficulties to comply food quality and safety standard. In this research, we use Quality Function Deployment (QFD) to link GMP elements and product standard parameters in order to identify GMP influence on product standa

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Magwenzi, S., C. Woodward, K. S. Wraith, et al. "Oxidised LDL activates blood platelets through CD36/NOX2-mediated inhibition of the cGMP/protein kinase G signalling cascade." 2015. http://hdl.handle.net/10454/17793.

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No<br>Oxidized low-density lipoprotein (oxLDL) promotes unregulated platelet activation in dyslipidemic disorders. Although oxLDL stimulates activatory signaling, it is unclear how these events drive accelerated thrombosis. Here, we describe a mechanism for oxLDL-mediated platelet hyperactivity that requires generation of reactive oxygen species (ROS). Under arterial flow, oxLDL triggered sustained generation of platelet intracellular ROS, which was blocked by CD36 inhibitors, mimicked by CD36-specific oxidized phospholipids, and ablated in CD36(-/-) murine platelets. oxLDL-induced ROS generat

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Chiu, Chia-Wen, and 邱佳雯. "Driving Force of Policy Change: A Case Study of Food Good Manufacturing Practice." Thesis, 2016. http://ndltd.ncl.edu.tw/handle/ury8kh.

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碩士<br>淡江大學<br>公共行政學系公共政策碩士班<br>104<br>In recent years, there are many food safety problems of products or food companies which have GMP logo. Because of the problems, issue of GMP is suitable or not has been discussed frequently. Government transferred GMP to Taiwan Quality Food Association and changed the name to TQF in the meantime. This essay based on past literatures about policy change to discover the factors of policy change, classified them into two categories, external factor and policy factor. Found out the reasons caused the abolishment of GMP and its policy change type, meanwhile, k

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Cheng, Chin-Jen, and 鄭智仁. "A Study Of Current Good Manufacturing Practice (cGMP) Execution Methods - An Example Of Purify Water System Validation." Thesis, 2007. http://ndltd.ncl.edu.tw/handle/47711006923697565789.

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碩士<br>逢甲大學<br>工業工程與系統管理學研究所<br>95<br>The drugs primarily focused on providing mankind with diagnosing disease, therapy, reducing a symptom or preventing disease. It is related to birth, aging, disease and death of human beings. Its quality affects the health of consumers directly. In order to insure the drugs safe, effective, stable, accurate, uniform, convenient and non-misapplication, pharmaceutical industry has to strictly control the drugs from R&D, manufacturing to marketing. Therefore, to insure medicine safety, government always takes tight control the pharmaceutical industry by regular

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Liao, Bi-Ru, and 廖碧如. "Applying SPC in the Current Good Manufacturing Practice (cGMP) Methods-An Example of Purify Water System Validation." Thesis, 2012. http://ndltd.ncl.edu.tw/handle/rcp95y.

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碩士<br>國立虎尾科技大學<br>工業工程與管理研究所<br>100<br>People’s health relates to public health policy, the quality of medical care, equipment and medicines. For medicine safety, government always supervises pharmaceutical industry by regular audit & inspection in order to insure the drug’s identity, strength, quality & purity.This study applying SPC in the cGMP standards facilitate the qualification, validation andmonitoring procedures of purified water system in pharmaceutical industry to meet the quality control and continuos improvement. This research is a case study , the Data collection includes three p

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Prunera, Arantxa Blazquez. "Effect of a good-manufacturing- practice xeno-free medium on mesenchymal stromal cell properties: Multipotentiality, immunomodulation and recruitment." Doctoral thesis, 2017. https://hdl.handle.net/10216/110921.

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Prunera, Arantxa Blazquez. "Effect of a good-manufacturing- practice xeno-free medium on mesenchymal stromal cell properties: Multipotentiality, immunomodulation and recruitment." Tese, 2017. https://hdl.handle.net/10216/110921.

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Nowakowska, Paulina. "Establishment of a good manufacturing practice-compliant procedure for expansion of therapeutic doses of genetically modified, CAR expressing NK-92 cells for the treatment of ErbB2-positive malignancies." Phd thesis, 2016. https://tuprints.ulb.tu-darmstadt.de/5855/1/Doktorarbeit%20Nowakowska%20Paulina%20.pdf.

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The NK-92/5.28.z cell line is an ErbB2 (HER2) specific, CAR-expressing continuously growing derivative of the clinically applicable NK-92 line, and exhibits profound and highly specific cytotoxicity against ErbB2-expressing tumor targets which are resistant to parental NK-92 cells. This study aimed to establish good manufacturing practice procedures enabling the generation of therapeutic doses of ErbB2-CAR expressing NK-92 cells for upcoming phase I/II clinical trials in ErbB2-overexpressing malignancies. The concept of patient dose manufacturing presented here encompasses the generation of a

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Ferreira, Óscar Gaël Mendes. "Controlo de qualidade na indústria farmacêutica." Master's thesis, 2019. http://hdl.handle.net/10284/8755.

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Cabe ao controlo de qualidade numa indústria farmacêutica a avaliação da qualidade do medicamento ao longo do processo de produção de forma a garantir a sua segurança e eficácia. Este controlo abrange todas as matérias-primas, o fabrico e o produto acabado. O controlo de qualidade é uma área essencial na indústria farmacêutica que deverá ter laboratórios próprios, independentes dos da produção e com pessoal especializado na condução de todos os testes a que o produto farmacêutico terá que ser sujeito. Este trabalho tem como objetivo perceber o estado da arte relativamente ao controlo de qualid

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Rainho, Inês Margarida Louro. "Validação das Folhas de Cálculo Eletrónicas dos Produtos Acabados e de Estabilidade dos Laboratórios Vitória, S.A." Master's thesis, 2018. http://hdl.handle.net/10362/58225.

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As folhas de cálculo eletrónicas são bastante utilizadas na indústria farmacêutica no processamento e registo de informação, sendo equiparadas aos sistemas computadorizados e consideradas registos eletrónicos quando armazenadas eletronicamente, sendo fundamental que cumpram todas as Boas Práticas de Fabrico relativas a estes dois aspetos e que sejam validadas de modo a assegurar que estas são cumpridas e que as folhas de cálculo eletrónicas estão corretas. Assim, um dos principais objetivos deste trabalho é a validação das folhas de cálculo eletrónicas dos produtos acabados e de estabilidade

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Mader, Derek Kelvin. "The application of total quality principles to the South African pharmaceutical industry." Diss., 1994. http://hdl.handle.net/10500/17283.

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The traditional quality culture in the pharmaceutical industry is driven by the regulatory process of marketing authorisation and manufacturing authorisation. These components of the South African regulatory control system are exclusively technically-orientated, with no managerial focus. This study identifies several quality management principles which could find general application in the pharmaceutical industry. The research compares the current regulatory control system with the total quality concept, and highlights the positive contribution which the total quality approach is able

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