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Gotowe bibliografie tematyczne / GMP (good manufacturing practice)

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Gotowa bibliografia na temat „GMP (good manufacturing practice)”

Autor: Grafiati

Data publikacji: 3 czerwca 2025

Data aktualizacji: 31 lipca 2025

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Artykuły w czasopismach na temat "GMP (good manufacturing practice)"

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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’s documents and records. Effective documentation boosts the visibility of the quality

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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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Satrio, Danang, and Wenti Ayu Sunarjo. "ANALISIS MUTU PRODUK UMKM MELALUI PENERAPAN GOOD MANUFACTURING PRACTICE." Derivatif : Jurnal Manajemen 17, no. 2 (2023): 320–28. https://doi.org/10.24127/jm.v17i2.1854.

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Salah satu upaya untuk mendorong dan mengembangkan industri-industri pengolahan skala kecil agar dapat memiliki mutu baik, aman dikonsumsi, tersedia secara berkesinambungan, dan berdaya saing tinggi secara ekonomis serta sesuai dengan selera masyarakat yaitu dengan mengendalikan proses pengolahan melalui sistem manajemen keamanan pangan berupa program kelayakan dasar berdasarkan konsep program manajemen mutu terpadu yaitu penerapan cara produksi pangan yang baik (CCPB) atauGood Manufacturing Practices(GMP). Tujuan dari penelitian ini adalah untuk Penelitian bertujuan mengidentifikasi penerapan

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Kuswardhani, Nita, Nidya Shara Mahardika, and Adine Rara Salsabila. "ANALISIS PENERAPAN GOOD MANUFACTURING PRACTICE (GMP) PADA PROSES PRODUKSI ROTI GEMBONG." Jurnal Penelitian Sains dan Teknologi Indonesia 3, no. 2 (2024): 357–68. https://doi.org/10.19184/jpsti.v3i2.1567.

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Perkembangan industri di Indonesia terus meningkat seiring dengan teknologi dan sistem produksi yang menunjang industri saat ini. Roti Gembong Hamasah merupakan salah satu perusahaan perseorangan yang bergerak di bidang pangan yaitu Roti Gembong. Evaluasi GMP mencakup 18 aspek seperti lokasi, bangunan, sanitasi, mesin, bahan, pengendalian proses, produk akhir, laboratorium, karyawan, pengemasan, label, penyimpanan, pemeliharaan, transportasi, dokumentasi, pelatihan, penarikan produk, dan penerapan pedoman. Analisis kesenjangan dengan metode gap analysis menunjukkan skor penerapan GMP sebesar 7

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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 & 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 & that is to prevent any kind of harm that can occur to the final user of the product.

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Kartika, Kartika, cecep abdul cholik,, and Sandi Kurnia. "ANALISA PENERAPAN GOOD MANUFACTURING PRACTICE (GMP) PRODUK OLAHAN ROTI (STUDI KASUS: SAE ROTI KUNINGAN)." Jurnal Fakultas Teknik 5, no. 2 (2024): 80–88. http://dx.doi.org/10.70476/jft.v5i2.6.

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Good Manufacturing Practice (GMP) is a reference for every food processing industry so that it can pay attention to food safety so that it can produce quality and healthy food for consumption. This research aims to: (1) determine the implementation of the Good Manufacturing Practice (GMP) system at SAE ROTI. (2) Identifying errors and deviations in the implementation of Good Manufacturing Practice (GMP) at SAE ROTI. (3) Providing solutions and recommending improvements to errors in implementing Good Manufacturing Practice (GMP). This research was conducted using qualitative methods. Data colle

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Avani, Reddy Alla, T. Cherian Kevin, Surapaneni Ramya, et al. "ROLE OF LOCAL MANUFACTURERS AND COMPETENT AUTHORITIES IN THE GOOD MANUFACTURING PRACTICE." International Journal of Current Pharmaceutical Review and Research 14, no. 01 (2022): 89–92. https://doi.org/10.5281/zenodo.12666223.

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Good Manufacturing Practice (GMP) is a set of quality control and assurance principles andguidelines that are essential in the manufacturing of pharmaceutical, biotechnological, andmedical device products. GMP ensures that these products are consistently produced andcontrolled according to established quality standards to ensure their safety, efficacy, andquality. Local manufacturers are responsible for understanding and complying with the GMPregulations and guidelines set by the regulatory authorities in their respective countries. Theymust ensure that their manufacturing processes, facilitie

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Sitepu, Syawal, Yulia Annisa, Raichan Izzati, Siti Shofiya Nasution, Durrah Hayati, and Ida Rosita. "Evaluasi Penerapan Good Manufacturing Practice (GMP) di Industri Kopi (studi kasus UD. XYZ)." Jurnal Ilmiah Mahasiswa Pertanian 9, no. 2 (2024): 106–13. https://doi.org/10.17969/jimfp.v9i2.30335.

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Good Manufacturing Practices (GMP) is a guideline that emphasizes food safety aspects for the Home Industry (IRT) to produce food that is good quality, safe and good for consumption. UD. XYZ is one of the arabica coffee producers located in Takengon, Central Aceh. Coffee processing at UD. XYZ starts from receiving raw materials which are then continued with grinding, washing, drying, and packaging to become green coffee beans that are ready to be distributed and marketed to the public. This study aims to evaluate the implementation of GMP at UD. XYZ. The results showed that UD. XYZ has impleme

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Shlopak, L. B. "Standards of Good Clinical Practice (GCP)." Spravočnik vrača obŝej praktiki (Journal of Family Medicine), no. 6 (May 28, 2023): 23–28. http://dx.doi.org/10.33920/med-10-2306-03.

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In the Eurasian Economic Union, the unified rules of Good Clinical Practice (GCP) came into force on May 6, 2017. These rules relate primarily to the circulation of medicines, and, along with good manufacturing practice (GMP) and good laboratory practice (GLP), are fundamental in matters of standardizing the quality of medical care for the population. The scope of these rules covers clinical trials of medicines, where the “subject” is an individual, and affects the ethical and moral aspects of conducting such trials [4]. Compliance with these rules is necessary when conducting clinical trials,

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Rozprawy doktorskie na temat "GMP (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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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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Książki na temat "GMP (good manufacturing practice)"

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

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Forum, GAMP. GAMP guide for validation of automated systems. Good automated manufacturing practice: GAMP 4. 4th ed. Society for Pharmaceutical and Medical Device Professionals, 2001.

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Yŏm, Yong-gwŏn. Cheyak sanŏp sŏnjinhwa kiban maryŏn ŭl wihan ŭiyakpʻum chŏnmun saengsan kiŏp yuksŏng mit illyŏk yangsŏng pangan yŏnʼgu =: Study on the plan of developing contract manufacturing organization (CMO) and training good manufacturing practice (GMP) specialist program for the preparation of advancing a pharmaceutical industry. Hanʼguk Pogŏn Sanŏp Chinhŭngwŏn, 2007.

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Yŏm, Yong-gwŏn. Cheyak sanŏp sŏnjinhwa kiban maryŏn ŭl wihan ŭiyakpʻum chŏnmun saengsan kiŏp yuksŏng mit illyŏk yangsŏng pangan yŏnʼgu =: Study on the plan of developing contract manufacturing organization (CMO) and training good manufacturing practice (GMP) specialist program for the preparation of advancing a pharmaceutical industry. Hanʼguk Pogŏn Sanŏp Chinhŭngwŏn, 2007.

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Indonesia. Direktorat Jenderal Bina Produksi Peternakan. Keputusan Direktur Jenderal Bina Produksi Peternakan nomor 20/SR.140/KPTS/F/09/03 tentang formulir daftar isian penilaian dan inspeksi penerapan cara pembuatan obat hewan yang baik (CPOHB) atau good manufacturing practice (GMP) pada produsen obat hewan. Kerjasama Direktorat Jenderal Bina Produksi Peternakan, Departemen Pertanian RI dengan Asosiasi Obat Hewan Indonesia, 2003.

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1930-, Crouthamel Thomas G., and United States. Food and Drug Administration., eds. Blood bank GMPS: The Food and Drug Administration's current good manufacturing practice regulations for pharmaceuticals and for blood and blood components parts 211,606 FDA investigator's checklist with references parts. Keystone Press, 1992.

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

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Części książek na temat "GMP (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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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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Dawids, S. "Rules for Good Manufacturing Practice (GMP) General Considerations." In Test Procedures for the Blood Compatibility of Biomaterials. Springer Netherlands, 1993. http://dx.doi.org/10.1007/978-94-011-1640-4_51.

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Türeli, Nazende Günday, and Akif Emre Türeli. "Good Manufacturing Practices (GMP) of Magnetic Nanoparticles." In Clinical Applications of Magnetic Nanoparticles. CRC Press, 2018. http://dx.doi.org/10.1201/9781315168258-26.

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Anderson, A., J. G. Maxwell, and H. M. Hill. "Chapter 21. Application of GLP in Analytical Chemistry with Cross Reference to GMP and GCP." In Good Clinical, Laboratory and Manufacturing Practices. Royal Society of Chemistry, 2007. http://dx.doi.org/10.1039/9781847557728-00279.

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Kerner, B., and P. Selosse. "A Plant for the Manufacturing of Virus Inactivated Plasma According to GMP-Guidelines." In Good Manufacturing Practice in Transfusion Medicine. Springer US, 1994. http://dx.doi.org/10.1007/978-1-4615-2608-7_19.

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Richter, Torsten, Maika Gulich, and Katja Richter. "Quality Control and Good Manufacturing Practice (GMP) for Chitosan-Based Biopharmaceutical Products." In Chitosan-Based Systems for Biopharmaceuticals. John Wiley & Sons, Ltd, 2012. http://dx.doi.org/10.1002/9781119962977.ch26.

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Jani, Upendra Krishnalal. "Good Manufacturing Practices (GMP): “Planning for Quality and Control in Microbiology”." In Frontier Discoveries and Innovations in Interdisciplinary Microbiology. Springer India, 2016. http://dx.doi.org/10.1007/978-81-322-2610-9_5.

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Streszczenia konferencji na temat "GMP (good manufacturing practice)"

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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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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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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 & 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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"Study of Implementation of Good Manufacturing Practices (GMP) in CV “XYZ”." In 3rd International Conference Eco-Innovation in Science, Engineering, and Technology. Galaxy Science, 2022. http://dx.doi.org/10.11594/nstp.2022.2709.

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Pranadikusumah, M., Vela Rostwentivaivi, and Ati Quddus. "Development of Good Manufacturing Practice (GMP) in the Form of a Practical-Oriented Application for Household Coffee Processing Guidelines." In Proceedings of the 1st International Conference on Islam, Science and Technology, ICONISTECH 2019, 11-12 July 2019, Bandung, Indonesia. EAI, 2020. http://dx.doi.org/10.4108/eai.11-7-2019.2297412.

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Amir, Astaman, Andi Arief, Sajriawati, Stenly Wairara, Gardis Andari, and Merry Dawapa. "Analysis Of Human Resources Skill To GMP (Good Manufacturing Practice) In The Fishery Processing Groups In Makassar City." In Proceedings of the International Conference on Social Science 2019 (ICSS 2019). Atlantis Press, 2019. http://dx.doi.org/10.2991/icss-19.2019.201.

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Oktavianty, Oke. "DIVERSIFICATION OF TEA PRODUCTS TO INCREASE MSME’S INCOME IN PELAWANFOREST AREA, CENTRAL BANGKA." In International conference on Innovation and Technology. JOURNAL OF INNOVATION AND APPLIED TECHNOLOGY, 2021. http://dx.doi.org/10.21776/ub.jiat.2021.se.01.015.

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This study aimed to assist the forestry managers of Pelawan Forest in increasing their income through the diversification and preparation of the products produced to meet food safety and other required standards so that the resulting products are ready to be exported to foreign countries. Aspects of Good Manufacturing Practice (GMP) – HACCP as a food safety aspect were used as an approach for product diversification. Lean manufacturing and green sustainability methods were used as methods to safe guard Pelawan Forest as a protected forest with Pelawan Forest being provided with assistance so t

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"Characterization of some raw materials from several sources for obtaining biodegradable packging." In 5th International Scientific Conference on Microbial Biotechnology. Institute of Microbiology and Biotechnology, Republic of Moldova, 2022. http://dx.doi.org/10.52757/imb22.18.

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Plastic materials in contact with food products must be manufactured in accordance with good manufacturing practices (GMP) and not transfer their components into food products in quantities that could endanger human health, change the composition of food products in a way unacceptable, or to damage the taste and smell of food products. An in-depth analysis of the results will lead to the definition of industrial specifications for packaging materials, in accordance with the needs, limitations and processing demands of existing plastic materials and with the performances required for the specif

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Guerra-Zubiaga, David A., Gershom Richards, Paul Forsberg, et al. "Integration of Digital Twins Into Virtual Commissioning Practices." In ASME 2024 International Mechanical Engineering Congress and Exposition. American Society of Mechanical Engineers, 2024. https://doi.org/10.1115/imece2024-145598.

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Abstract The demands of manufacturing equipment often led to operating the equipment most effectively to maximize productivity or profit. The need for maximized operating time for the equipment has made the maintenance aspect resort to more creative means to address the risk of equipment failure. The failure of equipment can range in effect from producing poor quality products, hindering the manufacturing process, or endangering the workers around them. Additionally, the damage done to equipment that has malfunctioned often causes a greater loss in profit as the equipment would need to be fixe

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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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Raporty organizacyjne na temat "GMP (good manufacturing practice)"

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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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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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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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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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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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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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Lubowa, Nasser, Zita Ekeocha, Stephen Robert Byrn, and Kari L. Clase. Pharmaceutical Industry in Uganda: A Review of the Common GMP Non-conformances during Regulatory Inspections. Purdue University, 2021. http://dx.doi.org/10.5703/1288284317442.

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The prevalence of substandard medicines in Africa is high but not well documented. Low and Middle-Income Countries (LMICs) are likely to face considerable challenges with substandard medications. Africa faces inadequate drug regulatory practices, and in general, compliance with Good Manufacturing Practices (GMP) in most of the pharmaceutical industries is lacking. The majority of pharmaceutical manufacturers in developing countries are often overwhelmed by the GMP requirements and therefore are unable to operate in line with internationally acceptable standards. Non-conformances observed durin

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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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