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Journal articles on the topic 'GMP EU'

Author: Grafiati

Published: 30 May 2022

Last updated: 31 July 2025

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1

He, Tian-Tian, Carolina Oi Lam Ung, Hao Hu, and Yi-Tao Wang. "Good manufacturing practice (GMP) regulation of herbal medicine in comparative research: China GMP, cGMP, WHO-GMP, PIC/S and EU-GMP." European Journal of Integrative Medicine 7, no. 1 (2015): 55–66. http://dx.doi.org/10.1016/j.eujim.2014.11.007.

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Grazal, John G., and David S. Earl. "EU and FDA GMP regulations: overview and comparison." Quality Assurance Journal 2, no. 2 (1997): 55–60. http://dx.doi.org/10.1002/(sici)1099-1786(199706)2:2<55::aid-qaj35>3.0.co;2-x.

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Luchi, Andrea, Maria Filomena de Andrade Rodrigues, Nathalia da Silva Couvo, and Patricia Léo. "Fabricação de Medicamentos Estéreis: Diretrizes para Controle de Contaminação." Revista IPT: Tecnologia e Inovação 7, no. 25 (2024): 43–61. http://dx.doi.org/10.29327/2202814.7.25-5.

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Este artigo tem como objetivo descrever brevemente as diretrizes de Boas Práticas de Fabricação (BPF) para medicamentos estéreis no Brasil (Instrução Normativa IN 35/2019), e fazer uma breve explanação comparada com as alterações já definidas nas diretrizes do EU GMP Anexo 1 da Comissão Europeia e PIC/s. De acordo com a Comissão Europeia foi necessária a revisão das diretrizes (EU GMP Anexo 1 – Fabricação de Medicamentos Estéreis) para atendimento regulatório e desenvolvimento tecnológico, alinhado com o ICH Q9 (Gerenciamento de Riscos da Qualidade), e ICH Q10 (Sistema de Qualidade Farmacêutic

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Ban, Eunmi, Dong-Jin Jang, Taek-Hyun Kwon, and Aeri Kim. "Pharmaceutical GMP Inspection: Case Study of USA and EU." Yakhak Hoeji 63, no. 1 (2019): 15–23. http://dx.doi.org/10.17480/psk.2019.63.1.15.

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Akshda Patil, Medha Devidas Kuchal, and Prasanthi Domaraju. "Comparison of GMP for Drugs in EU, US, Canada, WHO and Australia." International Journal of Drug Regulatory Affairs 12, no. 4 (2024): 82–91. https://doi.org/10.22270/ijdra.v12i4.724.

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Good Manufacturing Practices (GMP) are essential for ensuring the safety, quality, and efficacy of pharmaceutical products. GMP covers all aspects of production, including personnel training, equipment maintenance, and facility sanitation. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product. This article provides a comparative analysis of GMP regulations across five key regions: the European Union (EU), United States (US), World Health Organization (WHO), Canada, and Australia. The regulations and guidelines

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Meshkovskiy, A. P., N. V. Pyatigorskaya, Z. I. Aladysheva, et al. "Responsibilities of the Marketing Authorisation Holders in Respect of GMP Compliance (Review)." Drug development & registration 9, no. 4 (2020): 164–70. http://dx.doi.org/10.33380/2305-2066-2020-9-4-164-170.

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Introduction. The article is focused on differences in quality assurance-related obligations and responsibilities between Marketing Authorisation Holders (MAHs) and manufacturing authorisation holder (manufacturers) in pharmaceutical industry. In case of outsourcing and technical agreements there is a need to differentiate responsibilities related to quality assurance between the above mentioned categories.Text. The guidelines for the pharmaceutical sector of the European Union (EU) provide guidance on the responsibilities of the MAHs in relation to the GMP rules, which are scattered throughou

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Dr.N. Tamilselvan, Dr N. Tamilselvan, Ashly Mariam Suresh Ashly Mariam Suresh, Megha M. Pillai Megha M Pillai, Mira Bhaskar Mira Bhaskar, Srilakshmi Srilakshmi, and Swathi K. Sethu Swathi K Sethu. "Comparitive Analysis of Gmp Regulations For Sterile Products: India Vs Usa Vs Europe." International Journal of Pharmaceutical Research and Applications 10, no. 2 (2025): 1388–90. https://doi.org/10.35629/4494-100213881390.

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The objective of this study is to conduct a comparative analysis of Good Manufacturing Practice (GMP) regulations for sterile pharmaceutical products in India, the United States, and Europe. Parenteral products are intended to be non-pyrogenic, additionally to the requirement to be sterile. Medicinal drug products that do not meet the requirement to be sterile, nonpyrogenic can otherwise cause severe harm to life, threatening health risk to patient. It is necessary to know the differences in the requirements of guidelines given by different international agencies. For instance, the US FDA emph

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Чернышева, А. М., Е. А. Дегтерева, and С. Ю. Черников. "Development of the pharmaceutical industry in the EU and Russia: problems of interaction." Вестник МИРБИС, no. 1(29) (March 20, 2022): 20–28. http://dx.doi.org/10.25634/mirbis.2022.1.2.

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Важной составляющей взаимодействия компаний фармацевтической отрасли России и стран ЕС является соблюдение обязательных стандартов GMP и создание стратегических альянсов. Именно поэтому важно поддерживать создание и внедрение гармонизированных со странами ЕС нормативно-правовых актов, в рамках которых могут функционировать стратегические альянсы для развития не только отечественной фарминдустрии, но и развития экспортного потенциала. Целью настоящей статьи стало исследование проблем взаимодействия фармацевтических компаний на рынках ЕС и России. Для достижения поставленной цели были рассмотрен

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Wang, Fengyi, Xuan Hu, Jing Hu, et al. "Fluorescence assay for alkaline phosphatase activity based on energy transfer from terbium to europium in lanthanide coordination polymer nanoparticles." Journal of Materials Chemistry B 6, no. 37 (2018): 6008–15. http://dx.doi.org/10.1039/c8tb01713a.

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Filipiuc, Leontina-Elena, Raluca Ştefănescu, Carmen Solcan, et al. "Acute Toxicity and Pharmacokinetic Profile of an EU-GMP-Certified Cannabis sativa L. in Rodents." Pharmaceuticals 16, no. 5 (2023): 694. http://dx.doi.org/10.3390/ph16050694.

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The conundrum of Cannabis sativa’s applications for therapeutical purposes is set apart by the hundreds of known and commercially available strains, the social, cultural and historical context, and the legalization of its use for medical purposes in various jurisdictions around the globe. In an era where targeted therapies are continuously being developed and have become the norm, it is imperative to conduct standardized, controlled studies on strains currently cultivated under Good Manufacturing Practices (GMP) certification, a standard that guarantees the quality requirements for modern medi

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Berezovska, I. "LEGAL FRAMEWORK OF GOOD MANUFACTURING PRACTICE (GMP) FOR VETERINARY MEDICINAL PRODUCTS IN THE EU: EXPERIENCE FOR UKRAINE." Actual Problems of International Relations, no. 137 (2018): 65–76. http://dx.doi.org/10.17721/apmv.2018.137.0.65-76.

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The article comprehensively analyzes current legislation of the European Union on Good Manufacturing Practice (GMP) for veterinary medicinal products in particular the provisions of Directives No. 91/412 and No. 2001/82, and describes GMP main elements. It is noted that as a result of EU-Ukraine Association Agreement signing a new stage in the development of Ukrainian legislation regarding the turnover of veterinary medicinal products has begun, which is characterized by the increased impact of EU law on the legal regulation of this industry. The state of the appropriate national legislation r

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Kumar, Jayant, Ajmera Ramkishan, and Madhugiri Prakash Venkatesh. "Bridging the Gap: Aligning GMP Requirements for Generic Manufacturing across the US, EU and Japan." International Journal of Pharmaceutical Investigation 13, no. 3 (2023): 432–39. http://dx.doi.org/10.5530/ijpi.13.3.054.

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Marion, Dolezel, Bartel Andreas, and Heissenberger Andreas. "Spatial analysis of the occurrence of protected butterflies in six European biogeographic regions as a tool for the environmental risk assessment of Bt maize." BioRisk 13 (February 21, 2018): 31–52. https://doi.org/10.3897/biorisk.13.20688.

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In the environmental risk assessment (ERA) of genetically modified plants (GMP), the consideration of the different environments where genetically modified plants (GMP) will be commercially grown (the receiving environments) plays a crucial role. In addition, relevant protection goals which may be adversely affected by the GMP have to be considered during the ERA. Using a literature- and GIS-based approach, distribution data of protected lepidopteran species listed in Council Directive 92/43/EEC and of maize cultivation was used in order to evaluate potential spatial overlaps between GM maize

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Tomić, Siniša, Anita Sučić, and Adrijana Martinac. "Good Manufacturing Practice: The Role of Local Manufacturers and Competent Authorities." Archives of Industrial Hygiene and Toxicology 61, no. 4 (2010): 425–36. http://dx.doi.org/10.2478/10004-1254-61-2010-2035.

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Good Manufacturing Practice: The Role of Local Manufacturers and Competent AuthoritiesIn every country, a manufacturer of medicinal products for either human or veterinary use is required to operate in compliance with local legislation. In all EU Member States, legislation is approximated to the effect that they are committed to abide by the same standards. The candidate countries transpose the acquis into their national legislation, including the good manufacturing practice (GMP). Consequently, the local manufacturer is required to strictly comply with GMP and the manufacturing licence, inclu

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15

Sun, Jing-lin, and Bo-yang Yu. "The History and Prospects of Overseas GMP Inspection in China." Public Administration Research 11, no. 1 (2022): 24. http://dx.doi.org/10.5539/par.v11n1p24.

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Carrying out the overseas GMP (Good Manufacturing Practices) inspection is a key responsibility of the National Regulatory Agency to supervise the imported pharmaceutical products. And it&rsquo;s also an important measure to maintain the safety of the pharmaceutical products used by the public. In April 2011, China began to implement the pilot work of overseas GMP inspection. Through exploration and summary, a complete set of inspection procedures and systems have been formed. In this paper, the development history of China&#39;s overseas GMP inspection is reviewed, the inspection proc

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Chimenti, Isotta, Roberto Gaetani, Elvira Forte, et al. "Serum and supplement optimization for EU GMP ‐compliance in cardiospheres cell culture." Journal of Cellular and Molecular Medicine 18, no. 4 (2014): 624–34. http://dx.doi.org/10.1111/jcmm.12210.

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Nguyet, Pham Thi Anh. "Novel Findings from New Estimation between Green Monetary Policy and Environmental Sustainability in Europe: Does Institutional Quality Matter?" International Journal of Energy Economics and Policy 15, no. 4 (2025): 797–811. https://doi.org/10.32479/ijeep.19295.

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We expand the previous study on the link between green monetary policy index (GMP) and environmental sustainability (ES) by empirically examining the moderating role of institutional quality. Various econometric approaches were employed in the data set of 17 European Union (EU) member nations from 2001 to 2022. As in previous studies, our estimation results demonstrate that promoting green monetary policies can increase overall environmental performance (EPI). Additionally, promoting specific policies such as GMP_Credit_Operations, GMP_Foreign_Asset_Purchases, and GMP_Domestic_Asset_Purchases

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Gildehaus, Franz. "Aufbau eines GMP-Radionuklidlabors." Der Nuklearmediziner 40, no. 04 (2017): 253–61. http://dx.doi.org/10.1055/s-0043-111356.

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ZusammenfassungMit der Änderung des Arzneimittelgesetzes 2009 erfolgte eine Neubewertung der Herstellung von Radiopharmaka. Seitdem unterliegt ihre Herstellung grundsätzlich dem Arzneimittelgesetz, wobei dies nicht nur für nicht-zugelassene Radiopharmaka gilt, sondern ebenso für die Herstellung von Tc-Kits aus zugelassenen Mo/Tc-Generatoren mithilfe von zugelassenen Markierungskits. Die für die Herstellung verantwortliche Person muss laut § 13 (1) entweder eine sachkundige Person sein, oder nach § 13 (2b) ein Arzt, der auch persönlich die Anwendung bei einem bestimmten Patienten vornimmt. Die

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Pekarnikova, M. E., and K. B. Valiullina. "Legal regulation of methane emissions: The Global Methane Pledge in the national legislation of the major emitting countries." Uchenye Zapiski Kazanskogo Universiteta Seriya Gumanitarnye Nauki 167, no. 1 (2025): 169–83. https://doi.org/10.26907/2541-7738.2025.1.169-183.

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This article examines the measures that align with the 2015 Paris Agreement and the 2021 Global Methane Pledge (GMP) and restrict methane (СН4) emissions in the world’s largest methane hotspots. The primary focus is on the legal regulation of methane contents in the national legislation of the top ten emitting countries, with the European Union (EU) considered as a single emitter. The EU policy was analyzed in the context of the EU’s participation in the GMP as a sovereign entity under international law. The results obtained reveal that the Paris Agreement, which serves as the main regulatory

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Dolezel, Marion, Marianne Miklau, Andreas Heissenberger, Iris Kroeger, and Mathias Otto. "Complexity Meets Risk—The Next Generation of Genome-Edited Plants Challenges Established Concepts for Environmental Risk Assessment in the EU." Plants 14, no. 11 (2025): 1723. https://doi.org/10.3390/plants14111723.

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For 20 years, the environmental risk assessment (ERA) of genetically modified plants (GMPs) has used a comparative assessment approach, comparing the GMP to presumably safe and familiar non-modified plant varieties. With new genomic techniques, it is now possible to design complex GMP applications with systemic metabolic changes, resulting in novel plant phenotypes. These plant phenotypes can exhibit profoundly altered morphological, physiological, or compositional characteristics, intentionally lacking equivalence with parental plants and non-modified comparators. Through the analysis of case

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Lebanova, Hristina, Svetoslav Stoev, and Galina Petrova. "Analysis of non-compliances identified in GMP inspections between 2013 and 2022." Pharmacia 71, no. () (2024): 1–6. https://doi.org/10.3897/pharmacia.71.e120053.

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Ensuring the quality and safety of medicinal products is of paramount importance to the pharmaceutical industry. Good manufacturing practice (GMP) regulations are part of a pharmaceutical manufacturer's quality management system and ensure that medicinal products are manufactured, imported and controlled consistently to quality standards appropriate to their intended use. The aim of the present study is to analyze the non-compliant operations identified during GMP inspections carried out by national competent authorities (NCA) in the EU/EEC between 2013 and 2022. A retrospective analysis of no

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Souto, Eliana B., Gabriela F. Silva, João Dias-Ferreira, et al. "Nanopharmaceutics: Part I—Clinical Trials Legislation and Good Manufacturing Practices (GMP) of Nanotherapeutics in the EU." Pharmaceutics 12, no. 2 (2020): 146. http://dx.doi.org/10.3390/pharmaceutics12020146.

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The latest advances in pharmaceutical technology are leading to the development of cutting edged approaches to produce what is now known as the “Holy Grail” of medicine—nanopharmaceutics. Over the latest decade, the pharmaceutical industry has made important contributions to the scale up of these new products. To ensure their quality, efficacy, and safety for human use, clinical trials are mandatory. Yet, regulation regarding nanopharmaceuticals is still limited with a set of guidelines being recently released with respect to compliance with quality and safety. For the coming years, updates on

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Petit, Laetitia, Galle Pagny, Fabienne Baraige, Anne-Ccile Nignol, David Zhang, and Patrick Fach. "Characterization of Genetically Modified Maize in Weakly Contaminated Seed Batches and Identification of the Origin of the Adventitious Contamination." Journal of AOAC INTERNATIONAL 90, no. 4 (2007): 1098–106. http://dx.doi.org/10.1093/jaoac/90.4.1098.

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Abstract So far, relatively few genetically modified plants (GMPs) have been planted in the European Union (EU). However, in France, seed batches weakly contaminated by unidentified GM materials have recently been detected among commercial maize seeds (14 seed batches positive out of 447 analyzed). We have developed a 3-step approach to precisely identify the genetic modifications detected in such maize seed batches. First, to isolate GMPs derived from the contaminated seed batches, 10 000 maize seeds of each batch were planted and screened by polymerase chain reaction (PCR) on 100-plant batch

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Migdał, W., B. Zivkovic, and Ł. Migdał. "Promotion of animal products as opportunity for further development of breeding." Biotehnologija u stocarstvu 27, no. 4 (2011): 1407–16. http://dx.doi.org/10.2298/bah1104407m.

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In order to ensure safety of meat and meat products as well as necessary repeatability of products quality throughout the food chain, raw materials producers are required to ensure appropriate condition for production (both crops and breeding). It obligates to implementation and application systems such as: Good Agriculture Practise (GAP), Good Manufacturing Practice (GMP), Good Higiene Practice (GHP), and for intermediary companies participating in raw materials trade mandatory implementation of GHP and GMP system as well as HACCP (Hazard Analysis and Critical Control Point), QACP (Quality As

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Farkhani, Meigita Indah, and Ida Musfiroh. "Gap Analysis Kualifikasi Kinerja HVAC dan Mesin Sterilisator Berdasarkan CPOB dan EU GMP Terhadap Protokol di Salah Satu Industri Farmasi." Majalah Farmasetika 9, no. 4 (2024): 339–50. http://dx.doi.org/10.24198/mfarmasetika.v9i4.56399.

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Dalam memenuhi mutu suatu produk di industri farmassi, perlu dilakukan pengawasan salah satunya pada sistem tata udara dan mesin sterilisator untuk memastikan produk yang dihasilkan memiliki mutu yang konsisten baik dengan proses kualifikasi yang mengacu pada CPOB dan EU GMP sebagai pedoman produk yang dipasarkan di dalam negeri dan wilayah Eropa. Dengan adanya perkembangan pada pedoman yang digunakan, selanjutnya dilakukan analisa gap antara pedoman terbaru dengan protokol kerja yang digunakan. Protokol kualifikasi kinerja HVAC dan mesin sterilisator dibandingkan dengan pedoman, lalu dilakuka

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Lebanova, Hristina, Svetoslav Stoev, and Galina Petrova. "Analysis of non-compliances identified in GMP inspections between 2013 and 2022." Pharmacia 71 (March 8, 2024): 1–6. http://dx.doi.org/10.3897/pharmacia.71.e120053.

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Ensuring the quality and safety of medicinal products is of paramount importance to the pharmaceutical industry. Good manufacturing practice (GMP) regulations are part of a pharmaceutical manufacturer’s quality management system and ensure that medicinal products are manufactured, imported and controlled consistently to quality standards appropriate to their intended use. The aim of the present study is to analyze the non-compliant operations identified during GMP inspections carried out by national competent authorities (NCA) in the EU/EEC between 2013 and 2022. A retrospective analysis of no

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Pickova, Darina, Vladimir Ostry, Jan Malir, Jakub Toman, and Frantisek Malir. "A Review on Mycotoxins and Microfungi in Spices in the Light of the Last Five Years." Toxins 12, no. 12 (2020): 789. http://dx.doi.org/10.3390/toxins12120789.

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Spices are imported worldwide mainly from developing countries with tropical and/or subtropical climate. Local conditions, such as high temperature, heavy rainfall, and humidity, promote fungal growth leading to increased occurrence of mycotoxins in spices. Moreover, the lack of good agricultural practice (GAP), good manufacturing practice (GMP), and good hygienic practice (GHP) in developing countries are of great concern. This review summarizes recent data from a total of 56 original papers dealing with mycotoxins and microfungi in various spices in the last five years. A total of 38 kinds o

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Boersma, Hendrikus H., Mirte M. Woerdenbag, Sascha Mulder, et al. "Comprehensive Analysis of Environmental Monitoring Data from the Department of Nuclear Medicine and Molecular Imaging (NMMI) of the University Medical Center Groningen (UMCG)." Hygiene 4, no. 3 (2024): 282–96. http://dx.doi.org/10.3390/hygiene4030023.

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Environmental monitoring (EM) is the cornerstone for the assurance of sterility during aseptic manufacturing. In this study, the EM quality aspects in the radiopharmaceutical cleanrooms of the University Medical Center Groningen (UMCG), The Netherlands, were evaluated. Hereto, data obtained from EM over the period 2010–2022 were analyzed. The data were sorted according to the Good Manufacturing Practice (GMP) classification of the respective premises with their corresponding limits, and frequencies of excursions were determined per location. The frequency of conducted measurements gradually in

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Bainsal, Neeraj, Jitender Singh, Aanchal Gupta, and Kundan Singh Bora. "Relevance of Artificial Intelligence in a Retail Pharma Store: A Review." ECS Transactions 107, no. 1 (2022): 10575–83. http://dx.doi.org/10.1149/10701.10575ecst.

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Whole pharmaceutical areas needed various innovative and scientific solutions to solve the current problems related to cGMP practices, production, documentation, regulatory body requirements (USFDA, WHO, EU-GMP, PICS), quality of product, etc. To overcome such problems, different computer system software plays an important role by monitoring and maintaining the current practices of the pharma industry. Installing such software will help the pharma industry to improve their cGMP practices and fulfillment the regulatory body’s requirements. This article gives overview on different types of softw

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Orlov, V. A., and V. N. Shestakov. "Assessing the Correlation Between GMP Deviations and Potential Quality Defects of Medicinal Products: the Result of the Survey of Qualified Persons." Drug development & registration 9, no. 2 (2020): 151–58. http://dx.doi.org/10.33380/2305-2066-2020-9-2-151-158.

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Introduction. One of the key issues in the field of assessing the conformity of drug manufacturers with the requirements of good manufacturing practice (GMP) is a systematic methodology for classifying revealed deficiencies (deviations, non-conformities) by their level of criticality. Today the information included into regulatory documents regarding the definitions of critical, major and minor (other) deficiencies is not always sufficient for the use in GMP inspection practice, as well as in quality management systems of the pharmaceutical manufacturers. In terms to study approaches to the cl

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Jänsch, Stephan, Jörg Römbke, Jörg Römbke, et al. "Assessing the potential risks of transgenic plants for non-target invertebrates in Europe: a review of classification approaches of the receiving environment." BioRisk 6 (December 19, 2011): 19–40. https://doi.org/10.3897/biorisk.6.1334.

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According to the current legal background for the regulation of genetically modified plants (GMPs) in Europe, an environmental risk assessment (ERA) has to be performed considering i) the crop plant, ii) the novel trait relating to its intended effect and phenotypic characteristics of the GM crop plant and iii) the receiving environment related to the intended use of the GMP. However, the current GMP-ERA does not differentiate between different intended receiving environments. Therefore, the question is to be raised: How can the ’receiving environment’ be classified on the European scale, both

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Lim, Jieun, and Hea-Kyoung Cho. "An Analysis of the Factors Related to EU GMP Non-compliance - Focusing on Active Substance, Human Medicinal Product -." Yakhak Hoeji 65, no. 1 (2021): 46–55. http://dx.doi.org/10.17480/psk.2021.65.1.46.

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Becker, Fabienne, Stefanie Liedtke, Boris Greber, et al. "Abstract 23 HLA-Homozygous iPSC from Cord Blood for the Generation of Cardiomyocytes for Allogeneic Cell Therapy to the Heart." Stem Cells Translational Medicine 12, Supplement_1 (2023): S25. http://dx.doi.org/10.1093/stcltm/szad047.024.

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Abstract Introduction Based on a previous grant on HLA-homozygous (HLAh) iPS-GMP (and ATMP conform) generation from allogeneic licensed cord blood (CB) units, the Düsseldorf CBB could provide the most frequent HLA-types for reprogramming (Liedtke et al. 2020). These HLAh iPSC provide the basis for the generation of cardiomyocytes from iPSC. Patients with acute heart failure or cardiomyopathies have limited options of treatment. iPSC technology allows for de novo generation of functional heart muscle in vitro, enabling the implementation of new therapy concepts for heart regeneration. Objective

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Kumari, Mamta, Anubhav Dubey, Suruchi Agarwal, Saurabh Kushwaha, and Anupam Kr Sachan. "Recent Technology and Software for GDP in the Pharmaceutical Industry." International Journal of Pharmaceutical Sciences and Nanotechnology(IJPSN) 16, no. 5 (2023): 7004–7. http://dx.doi.org/10.37285/ijpsn.2023.16.5.9.

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You may agree with us when we say that the pharmaceutical business is not an easy one. It can prove to be quite a task to adapt to the changing healthcare standards, changing production requirements, changing government regulations, and incorporating the latest innovative technologies in the production process of drugs and medicines. Also, the competition is huge in the pharmaceutical business, and you can’t sustain long in the business if you cannot offer the best quality medicines to the customers at truly competitive prices. The whole pharmaceutical area needed various innovative and scient

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But, Iryna. "SPECIFICS OF TRAINING OF FUTURE SPECIALISTS IN INSTITUTIONS OF HIGHER PHARMACEUTICAL EDUCATION OF UKRAINE IN THE CONTEXT OF EXPECTATIONS OF THE STATE, SOCIETY AND MARKET ENVIRONMENT." Educational Discourse: collection of scientific papers, no. 42(10-12) (December 24, 2022): 88–97. http://dx.doi.org/10.33930/ed.2019.5007.42(10-12)-9.

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The implementation of the main models of the development of the global market environment until 2030 (‘Man is the main value’, ‘Innovation is a priority’, ‘Corporate care’, ‘Corporations - above all’) creates a perspective on reducing the orientation on a person, his/her motives for self-realization in the profession, and increases the probability of dominance of competitive advantages and capabilities of a specialist; application of breakthrough innovations and ideas, new business models, etc. At the end of June 2022, Ukraine's acquisition of the status of a candidate for membership in the Eu

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Bancǎ, Gh, F. Ivan, M. Toma, V. Nişulescu, and D. A. Micu. "Experimental research on vehicles equipped with a GMP Hybrid for the new Euro 7 emissions standard." IOP Conference Series: Materials Science and Engineering 1303, no. 1 (2024): 012026. http://dx.doi.org/10.1088/1757-899x/1303/1/012026.

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Abstract With the increase the number of vehicles on European roads, the road transport has become the biggest source of air pollution in the cities of the old continent. According to European Commission estimates in 2018, more than 39% of NOx (nitrogen oxides) emissions and 10% of PM2.5 and PM10 emissions (mechanical particles with diameters of 2.5 and 10 micrometers) were attributed to road transport. It is known that, in order to limit to some extent, the uncontrolled increase in harmful emissions from road vehicles, the European Commission has gradually introduced new pollution standards t

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Budnikevych, Iryna, and Vadym Honchar. "REGULATORY MECHANISMS OF UKRAINIAN PHARMACEUTICAL MARKET COMPETITIVENESS IN THE CONTEXT OF EUROPEAN INTEGRATION." Three Seas Economic Journal 1, no. 3 (2020): 1–8. http://dx.doi.org/10.30525/2661-5150/2020-3-1.

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The purpose of the paper is to summarize and present the differences in the competitive environment of the European Union (EU) and Ukrainian pharmaceutical markets. The method of longitudinal study allowed to detect the patterns of changes and correlations for pharmaceutical products exports and imports volumes over twenty years (2001-2020). Methodology. The research is based on the definition of the pharmaceutical market as a complex socio-economic institution that fulfills the function of pricing medical products and utilizes them to ensure health care functioning. It indicates the populatio

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Andriichuk, Bohdan, and Zinaida Samchuk-Kolodiazhna. "Legal Regulation of the Manufacturing Practice for Advanced Therapy Medicinal Products in the Context of Changes in the Current Legislation of Ukraine." Law and innovations, no. 4 (40) (December 19, 2022): 23–29. http://dx.doi.org/10.37772/2518-1718-2022-4(40)-4.

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Problem setting. The approximation of Ukrainian legislation to the European Union (EU) legislative framework allows for the improvement of systems for the production of innovative medicinal products, particularly advanced therapy medicinal products (ATMP). This, in turn, requires a properly updated legislative framework that must meet EU standards. The adoption of the guideline of the Ministry of Health of Ukraine 42-4.0:2020 marked a new stage in the regulation of the production practice of ATMP in Ukraine. However, the effectiveness of implementing the provisions of this Ukrainian guideline

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Sun, Zongbao, Yunlong Gao, Zeng Niu, et al. "Programmable-Printing Paper-Based Device with a MoS₂ NP and Gmp/Eu-Cit Fluorescence Couple for Ratiometric Tetracycline Analysis in Various Natural Samples." ACS Sensors 6, no. 11 (2021): 4038–47. http://dx.doi.org/10.1021/acssensors.1c01448.

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Sanap, Sachin L., Vinita V. Kale, Suankit A. Harane, and Milind J. Umekar. "Steps and requirements of preparing trial master file and clinical trial manufacturing documentation." International Journal of Clinical Trials 12, no. 3 (2025): 252–61. https://doi.org/10.18203/2349-3259.ijct20252204.

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The preparation of a trial master file (TMF) and clinical trial manufacturing documentation is fundamental to ensuring regulatory compliance, maintaining data integrity and supporting the successful execution of clinical trials. A well-organized TMF serves as a key repository for essential documents that allow the conduct of a clinical trial to be reconstructed and evaluated, ensuring adherence to ICH-GCP (E6 R2), FDA, EMA and MHRA guidelines. With the increasing adoption of electronic trial master files (eTMF), sponsors and clinical research organizations (CROs) are transitioning towards cent

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Savchenko, L. P., and V. A. Georgiyants. "Current trends in compounding of medicines and its legislative regulation in foreign countries." Farmatsevtychnyi zhurnal, no. 4 (July 30, 2020): 6–17. http://dx.doi.org/10.32352/0367-3057.4.20.01.

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Compounding medicines preparation is part of the proper pharmaceutical supply of the population. Unfortunately, its volumes in Ukraine have been declining recently, but the spread of medicines production in privately owned pharmacies indicates the prospects of this activity type. The aim of the work was the analysis of the current state of medicines compounding and its legislative regulation in foreign countries, formulation of the main directions of the Ukrainian legislation reforming on this issue. The materials of the research were scientific publications in peer-reviewed foreig

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Wang, Fujen, Indra Permana, Kwowhei Lee, Dibakar Rakshit, and Parisya Premiera Rosulindo. "Improvement of Airflow Distribution and Contamination Control for a Biotech Cleanroom." Atmosphere 13, no. 2 (2022): 335. http://dx.doi.org/10.3390/atmos13020335.

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The biotech cleanroom industry presents a biological basis for living organisms or their components (bacteria or enzymes) to produce helpful medicine. However, biotech industries such as vaccine production need a clean critical environment and contamination control that is always a vital concern for the manufacturing process. This study investigates a biotech cleanroom through a comprehensive field measurement and numerical simulation. The field measurement test results conformed to the design specification to satisfactorily meet with the cleanroom standard of PIC/S and EU GMP. Furthermore, th

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Matsuhama, Maki, Tomoko Takishita, Ryosuke Kuribayashi, Kazunori Takagi, Rika Wakao, and Kenichi Mikami. "Similarities and Differences of International Practices and Procedures for the Regulation for Active Substance Master Files/Drug Master Files of Human Use: Moving Toward Regulatory Convergence." Journal of Pharmacy & Pharmaceutical Sciences 19, no. 2 (2016): 290–300. http://dx.doi.org/10.18433/jpps.v19i2.27066.

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Purpose. A gap analysis survey of international practices for Active Substance Master Files (ASMFs)/Drug Master Files (DMFs) of human use was conducted as a project of the ASMF/DMF working group of the International Generic Drug Regulators Pilot (IGDRP) to identify similarities and differences among ASMF/DMF procedures of 10 IGDRP members and 2 observers. Methods. We conducted a questionnaire survey and compared the following aspects: overall ASMF/DMF procedures, submission requirements for ASMFs/DMFs, assessment processes for ASMFs/DMFs, the technical requirements for active pharmaceutical in

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Matsuhama, Maki, Tomoko Takishita, Ryosuke Kuribayashi, Kazunori Takagi, Rika Wakao, and Kenichi Mikami. "Similarities and Differences of International Practices and Procedures for the Regulation for Active Substance Master Files/Drug Master Files of Human Use: Moving Toward Regulatory Convergence." Journal of Pharmacy & Pharmaceutical Sciences 19, no. 2 (2016): 290. http://dx.doi.org/10.18433/j37g80.

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Purpose. A gap analysis survey of international practices for Active Substance Master Files (ASMFs)/Drug Master Files (DMFs) of human use was conducted as a project of the ASMF/DMF working group of the International Generic Drug Regulators Pilot (IGDRP) to identify similarities and differences among ASMF/DMF procedures of 10 IGDRP members and 2 observers. Methods. We conducted a questionnaire survey and compared the following aspects: overall ASMF/DMF procedures, submission requirements for ASMFs/DMFs, assessment processes for ASMFs/DMFs, the technical requirements for active pharmaceutical in

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Souto, Eliana B., Gabriela F. Silva, João Dias-Ferreira, et al. "Nanopharmaceutics: Part II—Production Scales and Clinically Compliant Production Methods." Nanomaterials 10, no. 3 (2020): 455. http://dx.doi.org/10.3390/nano10030455.

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Due the implementation of nanotechnologies in the pharmaceutical industry over the last few decades, new type of cutting-edge formulations—nanopharmaceutics—have been proposed. These comprise pharmaceutical products at the nanoscale, developed from different types of materials with the purpose to, e.g., overcome solubility problems of poorly water-soluble drugs, the pharmacokinetic and pharmacodynamic profiles of known drugs but also of new biomolecules, to modify the release profile of loaded compounds, or to decrease the risk of toxicity by providing site-specific delivery reducing the syste

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., Tanisha, Harsh Rastogi, and Mukund L. Bharti. "Applications of Various Software in Pharmaceuticals: A Review." INTERNATIONAL JOURNAL OF PHARMACEUTICAL EDUCATION AND RESEARCH (IJPER) 6, no. 01 (2024): 16–24. http://dx.doi.org/10.37021/ijper.v6i1.03.

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To address issues with current good manufacturing practices (cGMP), production, documentation, regulatory body requirements (US, FDA, WHO, EU-GMP, PICS), product quality, and other issues, the pharmaceutical industry as a whole needed a variety of creative and scientific solutions. One key tool in addressing these issues is computer system software, which monitors and upholds current industry practices. Installing such software will assist the pharmaceutical sector in meeting regulatory body standards and enhancing its cGMP processes. The pharmaceutical industry’s recent advancements have incr

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Huang, Chunyu, Ruixue Ma, Yuxin Luo, Guoyue Shi, Jingjing Deng, and Tianshu Zhou. "Stimulus Response of TPE-TS@Eu/GMP ICPs: Toward Colorimetric Sensing of an Anthrax Biomarker with Double Ratiometric Fluorescence and Its Coffee Ring Test Kit for Point-of-Use Application." Analytical Chemistry 92, no. 19 (2020): 12934–42. http://dx.doi.org/10.1021/acs.analchem.0c01570.

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Stanciu, Gabriela Dumitrita, Daniela-Carmen Ababei, Carmen Solcan, et al. "Exploring Cannabinoids with Enhanced Binding Affinity for Targeting the Expanded Endocannabinoid System: A Promising Therapeutic Strategy for Alzheimer’s Disease Treatment." Pharmaceuticals 17, no. 4 (2024): 530. http://dx.doi.org/10.3390/ph17040530.

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Despite decades of rigorous research and numerous clinical trials, Alzheimer’s disease (AD) stands as a notable healthcare challenge of this century, with effective therapeutic solutions remaining elusive. Recently, the endocannabinoid system (ECS) has emerged as an essential therapeutic target due to its regulatory role in different physiological processes, such as neuroprotection, modulation of inflammation, and synaptic plasticity. This aligns with previous research showing that cannabinoid receptor ligands have the potential to trigger the functional structure of neuronal and brain network

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Sandle, Tim. "An anatomy of a contamination control strategy for sterile manufacturing." Journal of GxP Compliance 25, no. 2 (2021): 1–10. https://doi.org/10.5281/zenodo.6981382.

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It is recognized that any contamination control strategy represents a cyclical process, designed to prompt the manufacturers to identify and resolve risk, and hence one that requires periodic review and update. While contamination control strategies are foremost discussed in relation to sterile manufacturing, most of the elements are applicable to non-sterile processing as well. Manufacturers of sterile pharmaceutical products are required to have a contamination control strategy, as required by Annex 1 of EU GMP. Such a strategy is also in keeping with the FDA Aseptic Filling Guidance. Contam

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Zhang, Jing, Shuchen Tang, and Pengqing Sun. "From Command-Control to Lifecycle Regulation: Balancing Innovation and Safety in China’s Pharmaceutical Legislation." Healthcare 13, no. 6 (2025): 588. https://doi.org/10.3390/healthcare13060588.

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Background: China’s pharmaceutical regulatory framework is undergoing a pivotal shift from a traditional “command-control” model to a “lifecycle regulation” approach, aiming to balance drug safety, innovation, and accessibility. This study systematically examines the evolution, achievements, and challenges of China’s regulatory reforms, offering insights for global pharmaceutical governance. Methods: Using a mixed-methods approach integrating historical analysis, policy text mining, and case studies, we reviewed the pharmaceutical laws and regulations enacted since 1949, supplemented by case s

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