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Littérature scientifique sur le sujet « Good Manufacturing »

Auteur : Grafiati

Publié le 2 juin 2025

Mis à jour le 19 juillet 2025

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Articles de revues sur le sujet "Good Manufacturing"

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SUGIHARA, M. "Good Manufacturing Practice." JAPANES JOURNAL OF MEDICAL INSTRUMENTATION 60, no. 5 (1990): 249–53. http://dx.doi.org/10.4286/ikakikaigaku.60.5_249.

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BOYD, LEE H. "Good Manufacturing Practices." Poultry Science 73, no. 9 (1994): 1419–22. http://dx.doi.org/10.3382/ps.0731419.

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Clark, Andrew P. Z., Hong Dixon, Norma L. Cantu, Larry A. Cabell, and Joe A. McDonough. "Good Manufacturing Practice." International Journal of Toxicology 32, no. 4_suppl (2013): 18S—29S. http://dx.doi.org/10.1177/1091581813490204.

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We have established a current good manufacturing practice (GMP) manufacturing process to produce a nanoparticle suspension of 1,1′-methylenebis-4-[(hydroxyimino)methyl]pyridinium dimethanesulfonate (MMB4 DMS) in cottonseed oil (CSO) as a nerve agent antidote for a Phase 1 clinical trial. Bis-pyridinium oximes such as MMB4 were previously developed for emergency treatment of organophosphate nerve agent intoxication. Many of these compounds offer efficacy superior to monopyridinium oximes, but they have poor thermal stability due to hydrolytic cleavage in aqueous solution. We previously developed a nonaqueous nanoparticle suspension to improve the hydrothermal stability, termed Enhanced Formulation (EF). An example of this formulation technology is a suspension of MMB4 DMS nanoparticles in CSO. Due to the profound effect of particle size distribution on product quality and performance, particle size must be controlled during the manufacturing process. Therefore, a particle size analysis method for MMB4 DMS in CSO was developed and validated to use in support of good laboratory practice/GMP development and production activities. Manufacturing of EF was accomplished by milling MMB4 DMS with CSO and zirconia beads in an agitator bead mill. The resulting bulk material was filled into 5-mL glass vials at a sterile fill facility and terminally sterilized by gamma irradiation. The clinical lot was tested and released, a Certificate of Analysis was issued, and a 3-year International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) stability study started. The drug product was placed in storage for Phase 1 clinical trial distribution. A dose delivery uniformity study was undertaken to ensure that the correct doses were delivered to the patients in the clinic.

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Ahmed, A. "Good manufacturing practices." ISBT Science Series 4, no. 1 (2009): 6–10. http://dx.doi.org/10.1111/j.1751-2824.2009.01207.x.

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Pradnya Santosh, Jadhav. "A Review on Good Manufacturing Practices for Radiopharmaceuticals." International Journal of Science and Research (IJSR) 10, no. 3 (2021): 1482–87. https://doi.org/10.21275/sr201220141632.

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Le Hir, Alain. "Good pharmaceutical manufacturing practices." Drug Development and Industrial Pharmacy 15, no. 6-7 (1989): 853–68. http://dx.doi.org/10.3109/03639048909043653.

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Zuck, TF. "Current good manufacturing practices." Transfusion 35, no. 11 (1995): 955–66. http://dx.doi.org/10.1046/j.1537-2995.1995.351196110902.x.

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Rooks, Brian. "A good week for manufacturing." Assembly Automation 20, no. 1 (2000): 46–51. http://dx.doi.org/10.1108/01445150010311680.

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Bizony, P. "Four wheels good? [car manufacturing]." Engineering & Technology 4, no. 16 (2009): 16–19. http://dx.doi.org/10.1049/et.2009.1600.

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Glaser, John A. "Good chemical manufacturing process criteria." Clean Technologies and Environmental Policy 16, no. 2 (2014): 217–23. http://dx.doi.org/10.1007/s10098-014-0725-8.

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Thèses sur le sujet "Good Manufacturing"

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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 in PAGGS-M und Fresh Frozen Plasma über einen Zeitraum von 28 Tagen gemessen und dokumentiert. Die Messung der Parameter, sowohl hämatologische als auch hämostaseologische und hämorheologische, erfolgte nach Standardmethoden. Die Ergebnisse waren insgesamt nicht zufriedenstellend. Ausschlaggebende Grundlage der Untersuchung sind die GMP-Richtlinien, die sich an den europäischen Normen orientieren. Zwar zeigten die Produkte, die routinemäßig hergestellt werden, wie auch die, die nur für diese Untersuchung produziert wurden, in vielen Bereichen ein Übereinstimmen mit den Vorschriften. Speziell auch die Qualität der gefilterten Erythrozytenkonzentrate, die besonders für Immunsupprimierte wegen ihres niedrigen Gehalts an Leukozyten verwendet werden, war in vielen Fällen gut. Die Ergebnisse der rheologischen Messungen glichen denen anderer Studien: so wurde ein Abfall der Fließfähigkeit über den Meßzeitraum hinweg beobachtet, was auf ein leichtes Schwellen der Zellen und eine Zunahme der Rigidität zurückzuführen ist. Fast durchgängig wich der Meßwert für den Hämatokrit der EK von der Richtlinie ab, am stärksten in PAGGS-M. Als Grund hierfür wurde eine Meßungenauigkeit des elektronischen Zellzählers bzw. die Methode der Bestimmung angesehen, so daß eine echte Abweichung als unwahrscheinlich anzusehen ist. Jedoch wurde die vorgeschriebene maximale Hämolyserate mit Ablauf der Haltbarkeit häufig überschritten, ebenso wie die gemessenen Leukozytenzahlen. Eine Vielzahl der Plasmen war durch Erythrozyten und Leukozyten kontaminiert. Durch häufige Waschvorgänge beim Auftauen von tiefgefrorenen EK wurde ein erhöhter Hb-Überstand erzeugt, das geforderte Mindestvolumen wurde dabei unterschritten. Daher ist festzuhalten, daß für jede untersuchte Produktgruppe Abweichungen festgestellt wurden, die in diesem Maße nicht tolerabel sind. Damit ist die Qualität der Produkte insgesamt als unzureichend zu bezeichnen. Der hier geführte Nachweis dieser Abweichungen ermöglichte die Einführung geänderter Herstellungsverfahren, so daß die heute erzeugten Produkte den Qualitätsvorschriften entsprechen.<br>72 blood donations and their follow-up products (red blood cell concentrates resuspended in PAGGS-M, leukocyte-reduced red cell concentrates and fresh frozen plasma) were investigated to check their quality. Additionally, tests were performed on blood components of which most were not part of the routine program in the Department of Hemostaseology and Transfusion Medicine in Homburg/Saar. Finally, rheological parameters of red blood cell concentrates in PAGGS-M and of fresh frozen plasma were measured and documented over a period of 28 days. The results were not satisfying. Both the routine products and the blood components which were only produced for this study met the GMP-guidelines in many cases. Especially the quality of leukocyte-reduced red blood cell concentrates which are used especially for the transfusion for immunocompromised patients was good. The results of the rheological measurements were similar to those of other studies: decreasing flow over a period of time which was put down to slight swelling of the cells and to a rise in erythrocyte rigidity. The average hematokrit of red cell concentrates was generally too low especially in PAGGS-M. The reason for this was thought to be the electronic cell counter or rather the method of measuring. Hemolysis after storage and mean leucocyte count often exceeded the official dates. Many samples of the FFP were contaminated with red and white blood cells. Repeated washing after thawing of frozen red blood cell concentrates caused an excess of extracellular haemoglobin and low concentrate volumes. Any deviation from the guidelines is not tolerable. After this study adjustments in the production could be made so blood products now meet all of the requirements.

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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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Singhvi, A. M. "Good governance for sustainable superior manufacturing performance : a novel model, methodology and roadmap." Thesis, Middlesex University, 2002. http://eprints.mdx.ac.uk/6360/.

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In the rapidly changing global scenario, it became increasingly clear that new thinking was required to make businesses competitive given the challenges of liberalised trade regimes, free flow of capital and knowledge. The prodigious marriage of computers, communications and technology provided lot more options to the consumers, competitors, employees, suppliers and providers of money alike. Customers and Consumers have become more demanding, not only in terms of product quality or costs but also innovations and detect free services. The Author, anticipating the change, advised the Chairman of the Aditya Birla Group, (with sales and assets in excess of 6 billion US dollars and having manufacturing sites in India, Thailand, Philippines, Thailand, Malaysia, Indonesia, Egypt and Canada), to focus on lifting the standards of Manufacturing in all his Units. The Author joined the Group in late 1996 as The President of World Class Manufacturing, a Corporate Function, as a direct reporter to the Chairman Some companies in the Group, which are making good profits, perceived themselves as World Class since they had obtained ISO Certification, and a few other Awards. Yet others were pursuing customers with their own definition of quality, costs and delivery. And some were pursuing improvement programs under external consultant's guidance. The business went on as usual, except more explanation of how competition was increasing, and generic statements like "ve are doing all we can to deal with the situation which should improve soon" It was in the above context that Author thought of trying holistic approach for Good Governance at all levels, at all locations, involving all employees and all activities with focus on Manufacturing since best of marketing efforts would be in vain if not backed up by a World Class product with right cost and delivery. Anticipating the future needs, Author wanted everyone to focus on Innovations and Intellectual Capital and highest levels of Productivity from the six Ms [we call it. Men or Women (People), Material, Machines, Methods, Measurement and Markets]. After studying current literature and case studies on the subject and interacting with his former employers in Europe, America, Africa and Asia, and his potential customers (the 67 Plants in 1997) Author devised a Model that was futuristic, holistic, simple to be understood as the 'Art of Managing the Workplace', small or big. This was supported by a detailed Road Map and Methodology for Implementation of the Revolution for Excellence in the Group. A set of unique actions that would change the Mindset and Inspire the troops were developed and applied. Each of the 67 Plants have developed and deployed its own actions for percolating the philosophy, concept, tools and technique for the Deployment, Assessment and Review for becoming a world class manufacturer (WCM) The results are most satisfying as, the Model, its Road Map and Methodology with actions for Sustaining the Momentum has led to significant improvements in Products, Processes, Mindset and Culture of the People; they have attained higher knowledge level in their work, become extremely customer focused and have sent positive signals to all the stakeholders about their ability to protect the future, enhancing the competitiveness of their business, and therefore the Nation, and thereby protect the future of the next generation of employees, investors as well as other stakeholders. The tangible savings (over a period of approximately 5 years) in both Indian rupees and UK Pounds Sterling are summarized here under. On an average there are savings of about 9.5 millions UK £ per year. The turnover of the group is about 5500 millions UK (E). The savings thus comes equivalent to about 0.2 % of the Group's turnover which is a substantial amount creating a big impact on bottom line.

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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 utili per ottenere la validazione GMP. Tale elaborato si pone l'obiettivo di esaminare il mondo della validazione farmaceutica, con focus sulla validazione OQ, Operational Qualification, di macchine automatiche per il packaging farmaceutico. Infine, viene fornita una proposta volta a migliorare la validazione OQ attraverso l'implementazione del Virtual Commissioning, una tecnologia che permette la messa in servizio virtuale di una macchina, utilizzando come caso studio un'azienda leader nella produzione di macchine automatiche per il confezionamento di prodotti farmaceutici.

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Poirier, Debra. "Implementation of six sigma at Company XYZ to eliminate finished good nonconformance." Online version, 2009. http://www.uwstout.edu/lib/thesis/2009/2009poirierd.pdf.

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Ngwa, Macceline Bih. "The application of good manufacturing practices as a quality approach to food safety in a food manufacturing establishment in the Western Cape South Africa." Thesis, Cape Peninsula University of Technology, 2017. http://hdl.handle.net/20.500.11838/2525.

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Thesis (MTech (Quality (Engineering)))--Cape Peninsula University of Technology, 2017.<br>Good Manufacturing Practices (GMP) is a segment of quality assurance which guarantees that food products produced are uniform and controlled to the appropriate quality standards for their required use and as expected by the marketing authority. A survey was carried out to assess the awareness and implementation level of GMP guidelines amongst manufacturers in the Western Cape, South Africa. Based on a literature review on GMP in the food manufacturing establishments a research problem was identified forming the crux of the research which reads as follows: “the lack of enforcement of approved standards within the food manufacturing establishments in the Western Cape Province, South Africa may result in the food product quality being questioned by consumers”. The objective of this study was to assess the awareness and implementation of GMP among food manufacturing establishments in the Western Cape. The literature was reviewed to discover what is currently known concerning GMP in the food manufacturing industries. Fresh food produce manufacturing establishments in the Western Cape Province South Africa were targeted for this study, with 52 responding to the questionnaires. Data was collected by means of self-administered structured questionnaires and individual face-to-face interviews with six of the establishments that participated in the questionnaires. Data for the questionnaires was analysed by means Statistical Package for Social Science (SPSS) version 19 software programme in order to generate descriptive statistical results and to determine potential areas for improvement in the establishments surveyed. Data for individual face-to-face interview was recorded by transcribing and analysed by inductive reasoning. In particular, Cronbach’s alpha was utilized to test the reliability of the key items of GMP.

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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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Löfman, Elin, and Caroline Jonsson. "Why are Companies Doing Good, and What Good Does it Do? : A Qualitative Study of Managers' Interpretations and Drivers of Adopting Sustainable Development Practices." Thesis, Umeå universitet, Företagsekonomi, 2016. http://urn.kb.se/resolve?urn=urn:nbn:se:umu:diva-122023.

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Despite being a fairly new concept, sustainable development is gaining more attention from social actors. The demand on companies to incorporate sustainable development practices is therefore increasing. Previous research has emphasized that companies are influential drivers of sustainable development practices and many claim to work actively with the issue, yet few have implemented such practices to a sufficient extent. Many companies who claim to be working actively with sustainable development were found to be uncertain of what it implies. Moreover, manufacturing companies tend to be greatly dependent on the consumption of raw material, energy and waste disposals and are therefore often affected by changes associated with sustainable development. Thus, the purpose of this study is to identify what drives manufacturing companies to commit to sustainable development practices. In the field Management of Sustainable Development, previous research has neglected drivers of sustainable development in relation to managers’ differing interpretations of the concept, constituting a research gap. It has also been suggested by previous research to investigate sustainable development from an organizational perspective, thus this study investigates individual managers’ interpretations and what drives companies to adopt sustainable development practices. The following research question has therefore guided this study: What drives manufacturing companies to adopt sustainable development practices and how do these drivers vary depending on managers’ interpretations of the term? In order to investigate this phenomenon and fulfill the purpose of our study, a qualitative approach was deemed most suitable. Six manufacturing companies in Västerbotten County were interviewed using a semi-structured approach. In addition, a triangulation method was used, where official and organizational documents were collected from each participating company to complement the interview data and decrease subjectivity. The analysis of our empirical data resulted in a compiled analysis of the key findings, where we found that manufacturing companies in Västerbotten perceive sustainable development as an ambiguous term and interpret it differently but consider environmental factors as a central feature of the term. Furthermore, we can conclude that the adoption of sustainable development practices is facilitated by establishing a separate sustainable development strategy or incorporating sustainable development into the company’s general business strategy.

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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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Livres sur le sujet "Good Manufacturing"

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Directorate, Canada Drugs. Good manufacturing practices. 3rd ed. Health and Welfare Canada = Santé et bien-être social Canada, 1989.

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Directorate, Canada Therapeutic Products, ed. Good manufacturing practices. 5th ed. Therapeutic Products Programme, Health Canada, 1998.

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Bunn, Graham P., ed. Good Manufacturing Practices for Pharmaceuticals. CRC Press, 2019. http://dx.doi.org/10.1201/9781315120669.

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D, Nally Joseph, ed. Good manufacturing practices for pharmaceuticals. 6th ed. Informa Healthcare, 2007.

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Rivera, Richard J. Device good manufacturing practices manual. 4th ed. U.S. Dept. of Health and Human Services, Public Health Service, Food and Drug Administration, Center for Devices and Radiological Health ; Washington, D.C. : For sale by the Supt. of Docs., U.S. G.P.O., 1987.

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Carson, Philip, and Nigel Dent, eds. Good Clinical, Laboratory and Manufacturing Practices. Royal Society of Chemistry, 2007. http://dx.doi.org/10.1039/9781847557728.

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Turksen, Kursad, ed. Stem Cells and Good Manufacturing Practices. Springer US, 2021. http://dx.doi.org/10.1007/978-1-0716-1327-6.

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Turksen, Kursad, ed. Stem Cells and Good Manufacturing Practices. Springer New York, 2015. http://dx.doi.org/10.1007/978-1-4939-2435-6.

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Manning. Food & Drink - Good Manufacturing Practice. Wiley-Blackwell, 2013. http://dx.doi.org/10.1002/9781118318225.

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Sibinga, C. Th Smit, P. C. Das, and H. J. Heiniger, eds. Good Manufacturing Practice in Transfusion Medicine. Springer US, 1994. http://dx.doi.org/10.1007/978-1-4615-2608-7.

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Chapitres de livres sur le sujet "Good Manufacturing"

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Ward, Owen P. "Good Manufacturing." In Bioprocessing. Springer US, 1991. http://dx.doi.org/10.1007/978-1-4615-3914-8_12.

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Nellis, David F., and Dennis F. Michiel. "Good Manufacturing Practices." In Encyclopedia of Cancer. Springer Berlin Heidelberg, 2015. http://dx.doi.org/10.1007/978-3-642-27841-9_2479-2.

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Nellis, David F., and Dennis F. Michiel. "Good Manufacturing Practices." In Encyclopedia of Cancer. Springer Berlin Heidelberg, 2016. http://dx.doi.org/10.1007/978-3-662-46875-3_2479.

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Nellis, David F., and Dennis F. Michiel. "Good Manufacturing Practices." In Encyclopedia of Cancer. Springer Berlin Heidelberg, 2011. http://dx.doi.org/10.1007/978-3-642-16483-5_2479.

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Nahler, Gerhard. "good manufacturing practice (GMP)." In Dictionary of Pharmaceutical Medicine. Springer Vienna, 2009. http://dx.doi.org/10.1007/978-3-211-89836-9_614.

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Oddgeirsson, Ólafur Sveinn. "Good Manufacturing Practice (GMP)." In Handbook of Food Safety Engineering. Wiley-Blackwell, 2012. http://dx.doi.org/10.1002/9781444355321.ch31.

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Parry, Dominic. "Worldwide Good Manufacturing Practices." In Good Manufacturing Practices for Pharmaceuticals. CRC Press, 2019. http://dx.doi.org/10.1201/9781315120669-23.

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Cramer, Michael M. "Employee Good Manufacturing Practices." In Food Plant Sanitation, 3rd ed. CRC Press, 2022. http://dx.doi.org/10.1201/9780429294341-9.

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Rieber, Robert W. "Being “Good” in “Bad” Places." In Manufacturing Social Distress. Springer US, 1997. http://dx.doi.org/10.1007/978-1-4899-0053-1_8.

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Levchuk, John W. "Compliance with Good Manufacturing Practice." In Chemists’ Views of Imaging Centers. Springer US, 1995. http://dx.doi.org/10.1007/978-1-4757-9670-4_11.

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Actes de conférences sur le sujet "Good Manufacturing"

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Miyaguchi, Kohei, Masao Joko, Rebekah Sheraw, and Tsuyoshi Idé. "Sequence-Aware Inline Measurement Attribution for Good-Bad Wafer Diagnosis : DM: Big Data Management and Machine Learning." In 2025 36th Annual SEMI Advanced Semiconductor Manufacturing Conference (ASMC). IEEE, 2025. https://doi.org/10.1109/asmc64512.2025.11010308.

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Seon, Guillaume, Yuri Nikishkov, Lauren Fergusson, and Andrew Makeev. "Predicting Formation of Manufacturing Defects in Contoured Composites." In Vertical Flight Society 74th Annual Forum & Technology Display. The Vertical Flight Society, 2018. http://dx.doi.org/10.4050/f-0074-2018-12815.

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Composite helicopter rotor components are typically thick and often have areas with a tight radius of curvature, which make them especially prone to process-induced defects, including wrinkles and voids at ply interfaces. Such flaws cause high rejection rates in production of flight-critical components and structure. This work seeks to fill the gaps in understanding generation of the noted defects in contoured polymer-matrix composite (PMC) laminates. In particular, understanding and modelling defect formation at the early stages of the manufacturing process might be the missing link to enable the development of practical engineering solutions allowing for better control of the manufacturing process of contoured composite parts. In this work, an approach based on a continuum description of the uncured prepreg material, including the initial bulk or void content, and finite element modelling (FEM) is used to simulate the consolidation process at the early stages of manufacturing of contoured laminates. The simulation predicts instabilities leading to formation of both wrinkles and voids at ply interfaces during laminate debulking or vacuum consolidation. Applicability of the method to consolidation in both closed-cavity and open-face tooling is also demonstrated. FEM results show good correlation with X-ray Computed Tomography data. This work also introduces a new simulation concept based on finite element and discrete modelling of voids at ply interfaces to improve accuracy of predicting their evolution during the debulking operations.

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Seon, Guillaume, Yuri Nikishkov, Lauren Fergusson, and Andrew Makeev. "Predicting Formation of Manufacturing Defects in Contoured Composites." In Vertical Flight Society 74th Annual Forum & Technology Display. The Vertical Flight Society, 2018. http://dx.doi.org/10.4050/f-0074-2018-12822.

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Composite helicopter rotor components are typically thick and often have areas with a tight radius of curvature, which make them especially prone to process-induced defects, including wrinkles and voids at ply interfaces. Such flaws cause high rejection rates in production of flight-critical components and structure. This work seeks to fill the gaps in understanding generation of the noted defects in contoured polymer-matrix composite (PMC) laminates. In particular, understanding and modelling defect formation at the early stages of the manufacturing process might be the missing link to enable the development of practical engineering solutions allowing for better control of the manufacturing process of contoured composite parts. In this work, an approach based on a continuum description of the uncured prepreg material, including the initial bulk or void content, and finite element modelling (FEM) is used to simulate the consolidation process at the early stages of manufacturing of contoured laminates. The simulation predicts instabilities leading to formation of both wrinkles and voids at ply interfaces during laminate debulking or vacuum consolidation. Applicability of the method to consolidation in both closed-cavity and open-face tooling is also demonstrated. FEM results show good correlation with X-ray Computed Tomography data. This work also introduces a new simulation concept based on finite element and discrete modelling of voids at ply interfaces to improve accuracy of predicting their evolution during the debulking operations.

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Sedighi, Somayeh, and Miklós Szanyi. "Good governance." In The Challenges of Analyzing Social and Economic Processes in the 21st Century. Szegedi Tudományegyetem Gazdaságtudományi Kar, 2020. http://dx.doi.org/10.14232/casep21c.10.

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Resource-rich countries experience a slow development rate in manufacturing sectors compared to countries with scarce resources. it has been a challenge to demystify the slow development in manufacturing sectors in those countries, therefore this study aimed to develop an efficient model to estimate the effects of good governance and natural resource rents on the performance of manufacturing export in countries endowed in natural resources. In this study world bank data for the year, 2000 to 2016 and the panel data model from 14 countries rich in natural resources were used alongside the six dependent variable indices including good governance, natural resource rents, real exchange rate, and gross domestic product (GDP). The results revealed that an increase in natural resources (NR), rule of low (RL), control of corruption (CC) as well as a reduction in inflation (INF) in countries under investigation will lead to increase in Manufacturing export. As well as an increase in Real Exchange Rate (RER) will lead to a reduction in the Manufacturing export of these countries. Hence demystify the slow development rate in manufacturing sectors in resource-rich countries.

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CHAN, JIMMY SF, YOLANDA YM CHOW, and WILLIAM CF CHEUNG. "A ROAD MAP TO GOOD MANUFACTURING PRACTICE." In Quality Management: A New Era - The First International Conference on Quality Management and Six Sigma. WORLD SCIENTIFIC, 2005. http://dx.doi.org/10.1142/9789812701930_0004.

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Cromley, Margaret. "APC system health indicators, or why Cpks aren't good enough." In Advanced Microelectronic Manufacturing, edited by Matt Hankinson and Christopher P. Ausschnitt. SPIE, 2003. http://dx.doi.org/10.1117/12.485302.

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Zeba, Gordana, Marina Dabic, Mirjana Cicak, and Tugrul Daim. "Artificial Intelligence in Manufacturing: Bibliometric and Content Analysis." In 2020 IEEE / ITU International Conference on Artificial Intelligence for Good (AI4G). IEEE, 2020. http://dx.doi.org/10.1109/ai4g50087.2020.9311087.

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Franceschini, F. "The ranking-aggregation problem in manufacturing: potential, pitfalls, and good practices." In Italian Manufacturing Association Conference. Materials Research Forum LLC, 2023. http://dx.doi.org/10.21741/9781644902714-33.

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Abstract. A number of experts, who individually rank a set of objects based on a certain attribute, and the need to aggregate the resulting (subjective) rankings into a collective judgement: these are the “ingredients” of the ranking-aggregation problem, which is typical of social choice, psychometrics and economics. This paper shows that the problem has many interesting applications even in manufacturing and must be approached with care, in order to avoid misleading results. Through a real-world case study concerning cobot-assisted manual (dis)assembly, the paper illustrates (i) a methodology to tackle the problem in a practical and effective way and (ii) various useful tools (e.g., for estimating the degree of concordance among experts, the consistency and robustness of collective judgment, etc.). The article is addressed to scientists and practitioners in the manufacturing field.

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Endoh, M., N. Shimizu, H. Yoda, and N. Waoatsuki. "Highly sensitive thin film magnetoresistive sensor with good linearity." In Fifth IEEE/CHMT International Electronic Manufacturing Technology Symposium, 1988, 'Design-to-Manufacturing Transfer Cycle. IEEE, 1988. http://dx.doi.org/10.1109/emts.1988.16179.

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Ing, Jeffrey, Jackie Hsieh, Dennis Hou, et al. "Edge-Cloud Collaboration Architecture for AI Transformation of SME Manufacturing Enterprises." In 2020 IEEE / ITU International Conference on Artificial Intelligence for Good (AI4G). IEEE, 2020. http://dx.doi.org/10.1109/ai4g50087.2020.9311075.

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Rapports d'organisations sur le sujet "Good Manufacturing"

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Iveson, Steven W. Good Manufacturing Practices (GMP) / Good Laboratory Practices (GLP) Review and Applicability for Chemical Security Enhancements. Office of Scientific and Technical Information (OSTI), 2014. http://dx.doi.org/10.2172/1259847.

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simpson, Andrew, Helen Beattie, Chrysanthi Lekka, et al. Wood dust exposures in manufacturing industries. HSE, 2024. http://dx.doi.org/10.69730/hse.23rr1211.

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Updated evidence on achievable exposure standards when good control practice measures are used in woodworking manufacturing. It consisted of two elements: site visits to companies to assess exposures and telephone interviews to better understand how to influence companies in improving exposure control

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Rao, Menaka, Kushagra Merchant, and Shantanu Menon. Good Business Lab: Designing for Wellbeing. Indian School Of Development Management, 2023. http://dx.doi.org/10.58178/2303.1019.

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This case study engages with the journey of Good Business Lab (GBL), a non-profit registered in Bengaluru in 2017 that today has offices across India, as well as the USA and Latin America. Good Business Lab aims to apply research to steer businesses (primarily in labor-intensive industries such as manufacturing), to invest in the wellbeing of their workers. Through its ability to marry rigorous research techniques to its concerted intent to strike the balance between business and worker, GBL today occupies a notable niche within the Indian social sector ecosystem. The case study explores the experience of GBL, which now includes almost 100 full-time employees, in designing an organization to operate at these edges and involving talent across different locations. For a young organization with a strong research and academic focus, GBL has paid unusually detailed attention to how it works within, how it can sustain itself and, in particular, how it can integrate lessons of the central conceptual strand of its research—wellbeing—into its own organizational precepts and practice.

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Ssebibubbu, Stuart, Moses Mulumba, Monalisa Chafewa, Maria Birungi, Nimrod Muhumuza, and Baguma Christopher. Analyzing the Capacities of National Medicines Regulatory Agencies To Regulate Vaccine Manufacturing in Africa. Afya na Haki, 2023. http://dx.doi.org/10.63010/k8nm.

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Pharmaceutical production and high-quality medical treatment require effective regulation. National Medicines Regulatory Authorities (NMRAs) oversee medicinal product manufacture, distribution, and sale. Analysing African NMRA capacity is necessary to identify gaps and improve regulatory mechanisms to ensure vaccination quality and public health. This paper employs qualitative methodology to analyze the legal, regulatory, and policy framework systems, which includes a desk review of relevant literature, a writing workshop, and key informant interviews as data sources in Eight countries, including Uganda, Rwanda, South Africa, Nigeria, Senegal, Malawi, Zimbabwe, and Ghana. The study employed thematic content analysis (TCA) to identify key themes or gaps related to the regulatory capacities of NMRAs in Africa. The study found that it is difficult for NMRAs in Africa to oversee the production of vaccines. Some of the challenges include inadequate infrastructure, varying levels of capacity, slow updates and revisions, and problems implementing Good Manufacturing Practice (GMP) standards that need to be addressed. The findings stress the need for regulatory harmonization, collaboration, and capacity building to strengthen Africa’s NMRAs. In conclusion, there is a need for amplification of NMRAs’ capabilities. The study recommends bolstering regulatory frameworks and systems, enhancing coordination and communication among agencies, establishing regional centers of excellence, utilizing technology to make data sharing more efficient, and encouraging partnerships and collaboration with industry stakeholders and international organizations.

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Uche, Chidi, Zita Ekeocha, Stephen Robert Byrn, and Kari L. Clase. Retrospective Study of Inspectors Competency in the Act of Writing GMP Inspection Report. Purdue University, 2021. http://dx.doi.org/10.5703/1288284317445.

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The research was a retrospective study of twenty-five Good Manufacturing Practice (GMP) inspection reports (from March 2017 through to December 2018) of a national medicine regulatory agency, drug Inspectorate, in West Africa, designed to assess the inspectors’ expertise in the act of inspection report writing. The investigation examined a paper-based tool of thirteen pre-registration Inspection reports and twelve GMP reassessment reports written prior and following an intervention program by external GMP trainers to enhance inspectors’ skill in pharmaceutical cGMP inspection. The study made use of quantitative analysis to investigate each team’s expertise in the act of writing GMP inspection report. Likewise, each report’s compliance with the requirements of three regulatory standards on GMP inspection report writing was ascertained. Impact of intervention program on lead inspectors’ competence was assessed. Lastly, gap in each team writing effectiveness, and lead inspectors’ abilities to deliver an effective report were determined. The results showed one of the inspection team (4.0%) wrote an excellent report. Two (8.0%) of the twenty-five inspection teams penned good inspection reports. Eleven (44.0%) teams drafted needs improvement reports and the remaining eleven teams (44.0%) prepared unacceptable reports. The excellent report and the two good reports had report format that meet expectation. One (50.0%) of the good reports showed the authors possess excellent knowledge of cGMP technical areas. The remain good report (50.0%) revealed the writers’ knowledge.as good. The excellent report showed the authors displayed partial mastery in the use of objective evidence while the two good reports disclosed theirs as having partial and evolving abilities. One of the teams (50.0%) that wrote good reports displayed good use of third person narrative past tense in report writing whereas the other team used the same tense and voice excellently. Generally, a sort of marginal level of performance was prominent among the inspection teams. A gap, if not tackled, will slow down regulatory process through increase report review, litigations that query report factual accuracy (AIHO, 2017) and delay in issuance of marketing authorization. In conclusion, trainings on quality attributes, such as technical content (Quality Management System (QMS) and Site), the use of objective evidence, assignment of risk levels to GMP violations and citing of applicable laws, regulation and guidelines that substantiate GMP observations, were recommended, to enhance knowledge sharing and regulators’ performance in the act of writing inspection report.

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Agu, Monica, Zita Ekeocha, Stephen Robert Byrn, and Kari L. Clase. The Impact of Mentoring as a GMP Capability Building Tool in The Pharmaceutical Manufacturing Industry in Nigeria. Purdue University, 2012. http://dx.doi.org/10.5703/1288284317447.

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Good Manufacturing Practices (GMP), a component of Pharmaceutical Quality Systems, is aimed primarily at managing and minimizing the risks inherent in pharmaceutical manufacture to ensure the quality, safety and efficacy of products. Provision of adequate number of personnel with the necessary qualifications/practical experience and their continuous training and evaluation of effectiveness of the training is the responsibility of the manufacturer. (World Health Organization [WHO], 2014; International Organization for Standardization [ISO], 2015). The classroom method of training that has been used for GMP capacity building in the pharmaceutical manufacturing industry in Nigeria over the years, delivered by experts from stringently regulated markets, have not yielded commensurate improvement in the Quality Management Systems (QMS) in the industry. It is necessary and long over-due to explore an alternative training method that has a track record of success in other sectors. A lot of studies carried out on mentoring as a development tool in several fields such as academia, medicine, business, research etc., reported positive outcomes. The aim of this study was to explore mentoring as an alternative GMP training method in the pharmaceutical manufacturing industry in Nigeria. Specifically, the aim of this study was to evaluate the impact of mentoring as a GMP capability building tool in the pharmaceutical manufacturing industry in Nigeria, with focus on GMP documentations in XYZ pharmaceutical manufacturing company located in South-Western region of Nigeria. The methodology comprised gap assessment of GMP documentation of XYZ company to generate current state data, development of training materials based on the identified gaps and use of the training materials for the mentoring sessions. The outcome of the study was outstanding as gap assessment identified the areas of need that enabled development efforts to be targeted at these areas, unlike generic classroom training. The mentees’ acceptance of the mentoring support was evident by their request for additional training in some other areas related to the microbiology operations that were not covered in the gap assessment. This result portrays mentoring as a promising tool for GMP capacity building, but more structured studies need to be conducted in this area to generate results that can be generalized.

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สังขะมาน, ศิริเชษฐ์. การสร้างมูลค่าเพิ่มของผลิตภัณฑ์แปรรูปข้าว : กรณีศึกษาจังหวัดยโสธร. จุฬาลงกรณ์มหาวิทยาลัย, 2016. https://doi.org/10.58837/chula.res.2016.65.

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โครงการวิจัย “การสร้างมูลค่าเพิ่มของผลิตภัณฑ์แปรรูปข้าว กรณีศึกษาจังหวัดยโสธร (Value creation for processed rice products: a case study of Yasothon Province)” นี้ มีวัตถุประสงค์เพื่อศึกษารูปแบบเชิงอุตสาหกรรมผลิตภัณฑ์แปรรูปข้าวเพื่อสร้างมูลค่าเพิ่ม ตั้งแต่ระดับต้นน้ำ กลางน้ำ และปลายน้ำ และจัดทำแนวทางในการผลักดันการพัฒนาอุตสาหกรรมผลิตภัณฑ์แปรรูปข้าวเพื่อสร้างมูลค่าเพิ่มในจังหวัดยโสธร ขอบเขตและวิธีการวิจัย ประกอบด้วยการศึกษาแนวทางการพัฒนาผลิตภัณฑ์แปรรูปข้าว และศักยภาพของจังหวัดยโสธรเพื่อรองรับการพัฒนาผลิตภัณฑ์แปรรูปข้าว โดยดำเนินการศึกษาทบทวนนโยบายยุทธศาสตร์การพัฒนาเศรษฐกิจอุตสาหกรรมที่เกี่ยวข้องกับพื้นที่ศึกษาโครงการฯ ทั้งในระดับชาติ ระดับหน่วยงาน และระดับพื้นที่ ตลอดจนการศึกษาการพัฒนาอุตสาหกรรมข้าวในพื้นที่โครงการฯ และเงื่อนไขการพัฒนาในเชิงพื้นที่ รวบรวมสถิติข้อมูล และการสำรวจภาคสนาม (Field Survey) มาวิเคราะห์ในประเด็นต่างๆ เพื่อจัดทำแนวทางการพัฒนาอุตสาหกรรมผลิตภัณฑ์แปรรูปข้าวในจังหวัดยโสธร อุตสาหกรรมข้าวของประเทศไทย ประกอบด้วยการผลิตข้าว อุตสาหกรรมแปรรูปข้าว และอุตสาหกรรมต่อเนื่องที่ใช้ผลิตภัณฑ์จากการแปรรูป แต่โดยส่วนใหญ่จะอยู่ในรูปของอุตสาหกรรมแปรรูปจากข้าวเปลือกเป็นข้าวสารแล้วจำหน่ายทั้งในประเทศและต่างประเทศ ส่วนอุตสาหกรรมต่อเนื่องที่ใช้ผลิตภัณฑ์จากการแปรรูปข้าวเป็นผลิตภัณฑ์ต่างๆเพื่อสร้างมูลค่าเพิ่มยังมีน้อย ดังนั้น การต่อยอดให้กับข้าวไทยเพื่อเป็นการสร้างมูลค่าเพิ่มให้กับผลผลิตข้าวสู่ “การผลิตข้าวเชิงคุณภาพ” และ "ผลิตภัณฑ์แปรรูปจากข้าว" นับเป็นทางเลือกที่จะทำให้ไทยก้าวพ้นจาก ผู้นำส่งออกข้าว “เชิงปริมาณ” ไปสู่การเป็นผู้นำที่ส่งออก “ข้าวเชิงคุณภาพและผลิตภัณฑ์แปรรูปจากข้าว” เพื่อเพิ่มโอกาสในการส่งออกท่ามกลางการแข่งขันในตลาดโลกที่มีแนวโน้มรุนแรงยิ่งขึ้น การจัดทำแนวทางการพัฒนาอุตสาหกรรมผลิตภัณฑ์แปรรูปจากข้าวของจังหวัดยโสธรนี้ มุ่งเน้นการเชื่อมโยงการพัฒนาเพื่อสร้างมูลค่าเพิ่ม (Value Added) และคุณค่าเพิ่ม (Value Creation) ของกระบวนการผลิตตั้งแต่แหล่งวัตถุดิบ (ต้นน้ำ) กระบวนการผลิตและแปรรูป (กลางน้ำตลอดจนการบริหารจัดการทางการตลาดเป้าหมาย (ปลายน้ำ) โดยมีระบบโลจิสติกส์และการคมนาคมขนส่งเป็นตัวกลางเชื่อมโยงกิจกรรมต่างๆ เข้าไว้ด้วยกัน โดย กระบวนการต้นน้ำ มุ่งเน้นดำเนินการพัฒนาและปรับปรุงการผลิตข้าวคุณภาพ ปลอดภัย มีโภชนาการสูงเพื่อสุขภาพ โดยนำเอางานวิจัยและนวัตกรรมใหม่ๆ เข้ามาดำเนินการให้มากขึ้น ส่งเสริมและสนับสนุนการขยายเครือข่ายเกษตรกรผู้ผลิตข้าวหอมมะลิอินทรีย์ และจัดทำระบบข้อมูลและสารสนเทศข้าวอินทรีย์ กระบวนการกลางน้ำ มุ่งเน้นดำเนินการสนับสนุนให้สถาบันการเงิน ปล่อยสินเชื่อดอกเบี้ยต่ำระยะสั้น ให้กับสหกรณ์การเกษตร/กลุ่มผู้ผลิตข้าว เพื่อการรวบรวมผลผลิตจากสมาชิกมาแปรรูปและจำหน่าย ส่งเสริมและสนับสนุนการพัฒนาผลิตภัณฑ์แปรรูปจากข้าวให้มีความหลากหลายมากขึ้นเพื่อสร้างมูลค่าเพิ่ม สนับสนุนให้นำความรู้ด้านเทคโนโลยีและนวัตกรรมที่มีอยู่แล้ว มาสร้างมูลค่าเพิ่มและคุณค่าเพิ่มจากการแปรรูปข้าว และสนับสนุนการพัฒนาบรรจุภัณฑ์สินค้าข้าวที่สามารถดึงดูดความสนใจจากผู้บริโภค และสร้างเอกลักษณ์ให้แก่ผลิตภัณฑ์ กระบวนการปลายน้ำ มุ่งเน้นดำเนินการสนับสนุนการเพิ่มช่องทางการตลาดในทุกระดับ สนับสนุนให้ผู้ผลิต/ผู้ประกอบการ สามารถเข้าถึงข้อมูลสารสนเทศด้านการตลาดที่จะนำมาวางแผนการผลิตและการตลาด และประชาสัมพันธ์เชิงรุก ให้ผู้บริโภคมีความเข้าใจข้าวอินทรีย์อย่างถูกต้อง เห็นถึงคุณค่า และประโยชน์ของข้าวและผลิตภัณฑ์จากข้าวอย่างต่อเนื่อง เพื่อกระตุ้นให้เกิดความต้องการจากผู้บริโภค สำหรับแนวทางการพัฒนาเชิงพื้นที่เพื่อเพิ่มขีดความสามารถทางการแข่งขันจะต้องได้รับการส่งเสริมและสนับสนุนจากภาครัฐในการผลักดันการพัฒนาเชิงพื้นที่ การวางแผนการใช้พื้นที่/ที่ดิน เพื่อรองรับการพัฒนาอุตสาหกรรม การขยายฐานการผลิตอุตสาหกรรม การพัฒนาเทคโนโลยีเพื่อเพิ่มประสิทธิภาพกระบวนการผลิตตามมาตรฐาน Good Manufacturing Practice (GMP) การพัฒนาโครงสร้างพื้นฐานและสิ่งอำนวยความสะดวกเพื่อสนับสนุนการค้าและการลงทุนของอุตสาหกรรมผลิตภัณฑ์แปรรูปข้าว เช่น การพัฒนาเครือข่ายคมนาคมขนส่ง ระบบโลจิสติกส์ ศูนย์กระจายสินค้าที่เชื่อมโยงทั้งในประเทศและต่างประเทศ เป็นต้น

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Williams. NR198603 Notched Tensile Test Procedure for Evaluating the Ductility of Seam Welds in ERW Pipe. Pipeline Research Council International, Inc. (PRCI), 1986. http://dx.doi.org/10.55274/r0011230.

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Although current manufacturing methods result in highly reliable welds in ERW pipe, occasional small bond line defects, difficult to detect with present nondestructive test techniques, still are found. The development of improved inspection techniques to permit the detection of such small defects is a difficult undertaking. An Alternative approach toward increasing the reliability of ERW pipe is to insure that the weld region is able to tolerate the presence of any undetected defects without failure, that is, to insure that the weld has adequate ductility. Studies were conducted to determine why welds in some ERW pipes failed to show acceptable weld ductility as defined by the ratio of notched tensile strength (NTS) to unnotched tensile strength (TS), when all other observations indicated that the welds had good weld ductility.

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Kwesiga, Victoria, Zita Ekeocha, Stephen Robert Byrn, and Kari L. Clase. Compliance to GMP guidelines for Herbal Manufacturers in East Africa: A Position Paper. Purdue University, 2021. http://dx.doi.org/10.5703/1288284317428.

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With the global increase in the use of traditional and complementary remedies for the prevention and treatment of illness, the quality and safety of these medicines have become a significant concern for all regulatory authorities. Herbal medicines are the most commonly used form of traditional and complementary medicines in the world and the efficacy and safety of herbal medicines, like conventional medicines, largely depends on their quality from planting to harvesting, preprocessing and final processing. Due to the inherent complexity of herbal medicines, often containing an array of active compounds, the primary processing of herbal medicines has a direct influence on their quality. Quality concerns are the reason why the medicines regulatory agencies insist that manufacturers of medicines strictly follow Good Manufacturing Practices since it is an essential tool to prevent instances of contamination, mix-ups, deviations, failures and errors. However, a strict application of GMP requirements is expensive and would drive the prices of the manufactured products up. As a result, a maturity level grading of facilities is proposed as a way of justifying the costs incurred for manufacturers desiring to reach a broader market and investing in continuous improvement. 36 Good Manufacturing Practice (GMP) inspection reports of local herbal manufacturers conducted by National Drug Authority were analyzed to establish the type and extent of deficiencies to GMP requirements for local herbal manufacturers in Uganda. The different GMP chapters and related sub-parameters constituted the variables used for the analysis of conformity to requirements. The primary outcome variable was the conclusion regarding compliance or noncompliance of the inspected local herbal manufacturing facility. GMP parameters that were frequently defaulted by local herbal manufacturers and the corresponding frequencies were identified. The Pearson Chi-square test was applied independently on each category to find the association that existed between conformity and the questions in each category. Only 22% (8) of the 30 inspected facilities were found to comply with GMP requirements, as per National Drug Authority (NDA) guidelines; while the majority of the facilities, 28 (78%), were found not to comply. Of the facilities inspected, 25 were undergoing GMP inspection for the first time. A total of 1,236 deficiency observations were made in the 36 inspection reports reviewed for the study. The mean for all deficiencies was 34.3, and the standard deviation was 15.829. 91.5% of the facilities did not have mechanisms for a record of market complaints; 80.9% did not meet documentation requirements; 78.9% did not have quality control measures in place, and 65.7% did not meet stores requirements. By encouraging a culture of self/voluntary improvement through the introduction of listing of manufacturers based on a maturity level grading, the National Drug Authority will improve the Herbal Medicines sector as per the mandate of improving the herbal medicine industry. Also, increased sensitization of all relevant stakeholders regarding the requirements for GMP should be intensified.

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Hibbard, R., and M. Bono. A Manufacturing Process for Precision Gold Support Rings for Laser Targets. Office of Scientific and Technical Information (OSTI), 2004. http://dx.doi.org/10.2172/15009804.

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