Relevant bibliographies by topics / Good Manufacturing Practice

Contents

  1. Journal articles
  2. Dissertations / Theses
  3. Books
  4. Book chapters
  5. Conference papers
  6. Reports

Academic literature on the topic 'Good Manufacturing Practice'

Author: Grafiati
Published: 4 June 2021
Last updated: 25 July 2025

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Journal articles on the topic "Good Manufacturing Practice"

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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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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 develope
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Kell, Douglas B., and Bernhard Sonnleitner. "GMP — good modelling practice: an essential component of good manufacturing practice." Trends in Biotechnology 13, no. 11 (1995): 481–92. http://dx.doi.org/10.1016/s0167-7799(00)89006-x.

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Kerner, B. "Good manufacturing practice and viral safety." Blood Coagulation & Fibrinolysis 6, Sup 2 (1995): S15—S19. http://dx.doi.org/10.1097/00001721-199506002-00004.

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Shin, Byungchul, and Sangbock Lee. "Suggestion for Good Manufacturing Practice of Radiopharmaceuticals." Journal of the Korean Society of Radiology 7, no. 6 (2013): 397–402. http://dx.doi.org/10.7742/jksr.2013.7.6.397.

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Vijay, Kumar, Bist Meenu, Banyal Arti, and Patial Kirti. "Golden Rules of Good Manufacturing Practice (GMP)." Journal of Pharma and Drug Regulatory Affairs 1, no. 1 (2019): 30–37. https://doi.org/10.5281/zenodo.2575336.

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<em>The basic rules in any good manufacturing practice (GMP) regulations postulate that the pharmaceutical manufacturer must maintain appropriate documentation and records. Documentation helps to build up a detailed interpretation of what a manufacturing function has done in the past and what it is doing now and, thus, it provides a base for planning what it is going to do in the future. Regulatory evaluators, during their inspections of manufacturing sites, often devote much time on examining a company&rsquo;s documents and records. Effective documentation boosts the visibility of the quality
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Schmidt, P. "Integrating accreditation, good laboratory practice and good manufacturing practice in an industrial analytical laboratory." Accreditation and Quality Assurance 4, no. 4 (1999): 129–32. http://dx.doi.org/10.1007/s007690050332.

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TANAKA, Hideo. "Good Manufacturing Practice of the Soy Sauce (Part1)." JOURNAL OF THE BREWING SOCIETY OF JAPAN 91, no. 10 (1996): 710–15. http://dx.doi.org/10.6013/jbrewsocjapan1988.91.710.

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Ertay, Türkan. "Current Good Manufacturing Practice for Radiopharmaceutical Products (GMPR)." Nuclear Medicine Seminars 6, no. 3 (2020): 295–306. http://dx.doi.org/10.4274/nts.galenos.2020.0025.

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Rampal, Abhimanyu, and S. P. Yamini Kanti. "Good Manufacturing Practice (GMP): History, structure and its significance." International Journal of Drug Regulatory Affairs 8, no. 4 (2020): 66–72. http://dx.doi.org/10.22270/ijdra.v8i4.439.

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Good Manufacturing Practice (GMP) is set of guidelines enforced by USFDA under 21 CFR. Every Manufacturer of Food, Cosmetics, Pharmaceuticals products, Medical Devices &amp; Dietary products should follow these guidelines in order to be sure that their product is safe and effective to be put in the market and for use by general population. The parameters of GMP for different Categories may vary but there is only one aim &amp; that is to prevent any kind of harm that can occur to the final user of the product.
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Dissertations / Theses on the topic "Good Manufacturing Practice"

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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
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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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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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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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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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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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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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Books on the topic "Good Manufacturing Practice"

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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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Sharp, John. Good manufacturing practice: Philosophy and applications. Interpharm Press, 1991.

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Japan, ed. Kaisei Yakujihō to GQP, GMP (good quality practice good manufacturing practice). Jihō, 2005.

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M, Berte L., ed. Introduction to transfusion service good manufacturing practice. American Association of Blood Banks, 1994.

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Gert, Auterhoff, and Commission of the European Communities., eds. EC guide to good manufacturing practice for medicinal products. 2nd ed. Editio Cantor Verlag, 1997.

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Rose, D. Good manufacturing practice guidelinesfor the processing of low-acid foods. Campden and Chorleywood Food Research Association, 1987.

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New Zealand. Ministry of Health. Therapeutics Section., ed. New Zealand code of good manufacturing practice for manufacture and distribution of therapeutic goods. Ministry of Health, Therapeutics Section, 1995.

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Institute of Food Science and Technology (UK)., ed. Food and drink: Good manufacturing practice : a guide to its responsible management. 3rd ed. Institute of Food Science and Technology (UK), 1991.

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Interpharm, ed. Internationally harmonized guide for Active Pharmaceutical Ingredients: Good manufacturing practice : (API guide). Interpharm Press, Inc., 1997.

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Book chapters on the topic "Good Manufacturing Practice"

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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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Syed Asif, Erfan, and Shahid Bader Usmani. "Good Manufacturing Practice (GMP), Good Lab Practice (GLP) and Good Documentation Practice (GDP)." In Basics of Pharmaceutical Manufacturing and Quality Operations. CRC Press, 2024. http://dx.doi.org/10.1201/9781003366393-1.

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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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Sarvari, Masoumeh, Sepideh Alavi-Moghadam, Bagher Larijani, Ilia Rezazadeh, and Babak Arjmand. "Principles of Good Manufacturing Practice." In Biomedical Product Development: Bench to Bedside. Springer International Publishing, 2020. http://dx.doi.org/10.1007/978-3-030-35626-2_6.

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Zuck, T. F. "The Good Manufacturing Practice Concept." In Good Manufacturing Practice in Transfusion Medicine. Springer US, 1994. http://dx.doi.org/10.1007/978-1-4615-2608-7_4.

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Wells, F. "Good Clinical (Research) Practice." In Good Manufacturing Practice in Transfusion Medicine. Springer US, 1994. http://dx.doi.org/10.1007/978-1-4615-2608-7_22.

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Negut, Marian. "Good Manufacturing Practice and Licensed Products." In Maximizing the Security and Development Benefits from the Biological and Toxin Weapons Convention. Springer Netherlands, 2002. http://dx.doi.org/10.1007/978-94-010-0472-5_25.

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Dolman, J. R. "Chapter 26. Introduction: Good Manufacturing Practice." In Good Clinical, Laboratory and Manufacturing Practices. Royal Society of Chemistry, 2007. http://dx.doi.org/10.1039/9781847557728-00369.

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Bailes, D. "Chapter 8. Good Clinical Practice/Good Manufacturing Practice (GCP/GMP) Interface, Investigational Product Accountability." In Good Clinical, Laboratory and Manufacturing Practices. Royal Society of Chemistry, 2007. http://dx.doi.org/10.1039/9781847557728-00109.

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Conference papers on the topic "Good Manufacturing Practice"

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McMaster, James A. "Rationalization of Unalloyed Titanium Material Specifications to Current Production Capabilities Offers Opportunities for the Titanium Industry." In CORROSION 2003. NACE International, 2003. https://doi.org/10.5006/c2003-03461.

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Abstract The basic chemistry and mechanical properties of the unalloyed titanium grades, and by extension, their palladium and ruthenium enhanced counterparts, in the ASTM mill product specifications were established over 40 years ago. Broad specification limits were included so producers could meet the mechanical and chemical requirements at a time when melting and manufacturing control were not, by today’s standards, very good. Based on a study of over 400 recent commercial unalloyed titanium test reports, there may be an opportunity to improve the ASTM mill product specifications by making
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Zambrano, Consuelo Del Pilar Vega, Nikolaos A. Diangelakis, and Vassilis M. Charitopoulos. "Closed-Loop Data-Driven Model Predictive Control For A Wet Granulation Process Of Continuous Pharmaceutical Tablet Production." In The 35th European Symposium on Computer Aided Process Engineering. PSE Press, 2025. https://doi.org/10.69997/sct.192802.

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In 2023, the International Council for Harmonisation (ICH) guideline for the development, implementation, and lifecycle management of pharmaceutical continuous manufacturing (PCM), was implemented in Europe. It promotes quality-by-design (QbD) and quality by control (QbC) strategies as well as the appropriate use of mathematical modelling. This development urges a harmonizing understanding across academia and industry for adoption of interpretable models instead of black-box models for advanced control strategies such as model predictive control (MPC), especially when applied in Good Manufactu
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O’Malley, Cynthia. "No Place for Hipsters When the Substance behind a Pretty Façade is Required." In SSPC 2013 Greencoat. SSPC, 2013. https://doi.org/10.5006/s2013-00050.

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Abstract In contrast to the Hipster projected or “posed” image based solely upon appearance in lieu of substance, a company’s brand-image projected by paints &amp; coatings requires performance derived from consistently sound chemistry and manufacturing. The protective paints and coatings on the façade of commercial buildings are a significant aspect of the image associated with the owner organization. A coating with chemical functionality and consistent performance is required in order for the façade to remain an asset and not become a liability. In other words, the “substance” of the coating
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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
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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
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Sahab, Alkholi, Mirzaiee Ebrahim, and Daróczi Miklós. "Implementing Lean Tools to Improve a Production Line in a Given Company." In 10th International Scientific Conference on Advances in Mechanical Engineering. Trans Tech Publications Ltd, 2025. https://doi.org/10.4028/p-8bzqhf.

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In the competitive landscape of today's automotive industry, achieving excellence is fundamental. Our paper delves into the practical application of lean manufacturing principles within a given company.Drawing on collaborative efforts with industry experts and professionals, this paper documents practical experiences gained in the field of production management. By implementing various lean tools on one of the production lines in the company, significant strides were taken towards continuous improvement, resulting in enhanced productivity, reduced lead times, and heightened customer satisfacti
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Chambers, Brian, Willem Maarten van Haaften, and Boris J. C. Thomas. "Justification and Recommendation for a High Sour Region beyond NACE MR0175 / ISO15156 Region 3." In CONFERENCE 2025. AMPP, 2025. https://doi.org/10.5006/c2025-00386.

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NACE MR0175 / ISO15156 is the global standard for metallic materials suitability for H2S-containing (sour) oil and gas production environments. For carbon and low alloy steels, it currently advises suitability based on four (4) regions of environmental severity with respect to sulfide stress cracking (SSC): Region 0 (least aggressive) through Region 3 (most aggressive). Suitability for materials in Region 3 requires hardness and manufacturing restrictions or qualification in 0.1 MPa H2S environment. This test condition is arguably in the “middle” of the plotted area of Region 3 with significan
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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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Jali, Mohd Bakri, Maaruf Abdul Ghani, and Norazmir Md Nor. "The confusion in complying with good manufacturing practice requirements in Malaysia." In THE 2016 UKM FST POSTGRADUATE COLLOQUIUM: Proceedings of the Universiti Kebangsaan Malaysia, Faculty of Science and Technology 2016 Postgraduate Colloquium. Author(s), 2016. http://dx.doi.org/10.1063/1.4966770.

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Meyliana, Surjandy, Erick Fernando, Cadelina Cassandra, and Marjuki. "Propose Model Blockchain Technology Based Good Manufacturing Practice Model of Pharmacy Industry in Indonesia." In 2021 2nd International Conference on Innovative and Creative Information Technology (ICITech). IEEE, 2021. http://dx.doi.org/10.1109/icitech50181.2021.9590120.

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Reports on the topic "Good Manufacturing Practice"

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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 e
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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 โดยดำเนินการศึกษาทบทวนนโยบายยุทธศาสตร์การพัฒนาเศรษฐกิจอุตสาหกรรมที่เกี่ยวข้อง
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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, includ
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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 u
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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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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
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Shiihi, Solomon, U. G. Okafor, Zita Ekeocha, Stephen Robert Byrn, and Kari L. Clase. Improving the Outcome of GMP Inspections by Improving Proficiency of Inspectors through Consistent GMP Trainings. Purdue University, 2021. http://dx.doi.org/10.5703/1288284317433.

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Approximately 90% of the pharmaceutical inspectors in a pharmacy practice regulatory agency in West Africa have not updated their training on Good Manufacturing Practice (GMP) inspection in at least eight years. However, in the last two years the inspectors relied on learning-on-the job skills. During this time, the agency introduced about 17% of its inspectors to hands-on GMP trainings. GMP is the part of quality assurance that ensures the production or manufacture of medicinal products is consistent in order to control the quality standards appropriate for their intended use as required by t
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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
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Rosenfeld. L51686 Effect of Defect Size and Yield to Tensile Ratio on Plastic Deformation Capacity Pipeline Steels. Pipeline Research Council International, Inc. (PRCI), 1993. http://dx.doi.org/10.55274/r0010160.

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Micro-alloyed low-carbon linepipe steels offer an advantageous combination of high toughness and a low carbon equivalent (CE or Pcm) for good weldability. The continuing improvements in pipeline steel manufacturing practices have also led to pipeline steels with higher yield to tensile (Y/T) ratios and a corresponding reduction in strain hardening capacity. Potential users of high Y/T ratio pipeline steels are somewhat reluctant to modify their existing specifications. This is because they do not have the required information to judge the performance characteristics of such steels under a wide
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