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Articles de revues sur le sujet « Pharmaceutical Manufacturing Risks »

Auteur : Grafiati

Publié le 2 juin 2025

Mis à jour le 31 juillet 2025

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1

Mechal, Dinku, and Bekele Boche. "The effect of supply chain risks management practices on operational performance of pharmaceutical manufacturing companies in Addis Ababa, Ethiopia: Analytical cross-sectional study." PLOS One 20, no. 5 (2025): e0321311. https://doi.org/10.1371/journal.pone.0321311.

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Background The efficient movement of pharmaceuticals through various stakeholders to reach customers in the appropriate quantity and at the right time is achieved through supply chain management. However, the intricate nature of supply chain processes poses tremendous supply chain risks and jeopardizing pharmaceutical manufacturing company’s ability. Failure to address these risks can hinder the provision of high-quality health services. However, effective supply chain risk management can foster more resilient and efficient global supply chains. Therefore, this study aimed to investigate the e

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Tashpulatova, Feruza Sh. "Occupational health and safety (OHS) assurance in pharmaceutical manufacturing." American Journal of Medical Sciences and Pharmaceutical Research 7, no. 5 (2025): 80–84. https://doi.org/10.37547/tajmspr/volume07issue05-14.

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The specific features of occupational health and safety (OHS) assurance in pharmaceutical manufacturing have been analysed. The regulatory framework and the main risks associated with physical, chemical and ergonomic factors are examined. A systemic set of organisational, technical, sanitary and hygienic measures and socio-economic methods adapted to the particularities of pharmaceutical production is presented. Four practical case studies (evacuation SOP, microbiological air-contamination monitoring, solvent-evaporation prevention, ergonomics on packaging lines) are provided, together with an

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Elmadhoun, Bassam, Rawidh Alsaidalani, and Frank Burczynski. "Quality Risk Management in the Final Operational Stage of Sterile Pharmaceutical Manufacturing: A Case Study Highlighting the Management of Sustainable Related Risks in Product Sterilization, Inspection, Labeling, Packaging, and Storage Processes." Sustainability 17, no. 4 (2025): 1670. https://doi.org/10.3390/su17041670.

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Quality risk management, commonly known as QRM, is designed to systematically assess, control, communicate, and review potential risks at every stage of the pharmaceutical manufacturing process. The preservation of consistent product quality across the entirety of the product’s life cycle is of paramount importance. The aim of this article is to formulate a best practice guide that will assist pharmaceutical manufacturers in comprehending and implementing the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q9: quality risk management pr

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Pyatigorsky, Alexander M., Galina E. Brkich, Valery V. Beregovykh, Natalia V. Pyatigorskaya, Oleg A. Zyryanov, and Andrey O. Kuznetsov. "Pharmaceutical Product Manufacturing Readiness Levels." Annals of the Russian academy of medical sciences 80, no. 2 (2025): 138–45. https://doi.org/10.15690/vramn18036.

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With a high level of fundamental research, there is a gap between fundamental and applied research, and there is a discrepancy between the proposed research results and possible integration into industrial production cycles. Within the life cycle of a pharmaceutical product, reliable processes are the foundation for the successful operation of the enterprise. The duration of development of pharmaceutical products and projects for their implementation require the involvement of significant resources and are associated with significant risks. Starting from the earliest stages of project implemen

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Arnold, Kathryn E., Alistair B. A. Boxall, A. Ross Brown, et al. "Assessing the exposure risk and impacts of pharmaceuticals in the environment on individuals and ecosystems." Biology Letters 9, no. 4 (2013): 20130492. http://dx.doi.org/10.1098/rsbl.2013.0492.

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The use of human and veterinary pharmaceuticals is increasing. Over the past decade, there has been a proliferation of research into potential environmental impacts of pharmaceuticals in the environment. A Royal Society-supported seminar brought together experts from diverse scientific fields to discuss the risks posed by pharmaceuticals to wildlife. Recent analytical advances have revealed that pharmaceuticals are entering habitats via water, sewage, manure and animal carcases, and dispersing through food chains. Pharmaceuticals are designed to alter physiology at low doses and so can be part

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Hock, Sia Chong, Teh Kee Siang, and Chan Lai Wah. "Continuous manufacturing versus batch manufacturing: benefits, opportunities and challenges for manufacturers and regulators." Generics and Biosimilars Initiative Journal 10, no. 1 (2021): 44–56. http://dx.doi.org/10.5639/gabij.2021.1001.004.

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Continuous manufacturing (CM) is the integration of a series of unit operations, processing materials continually to produce the final pharmaceutical product. In recent years, CM of pharmaceuticals has transformed from buzzword to reality, with at least eight currently approved drugs produced by CM. Propelled by various driving forces, manufacturers and regulators have recognized the benefits of CM and are awaiting the completion of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q13, a harmonized guideline on CM that would be imple

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Attaianese, Erminia, and Gabriella Duca. "The integrated assessment of occupational risks in a pharmaceutical manufacturing plant." Work 41 (2012): 1733–38. http://dx.doi.org/10.3233/wor-2012-0377-1733.

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Dr., Someshwar Mankar* Riya Chabukswar Arti Chaudhari Sakshi Chavan Yuvraj Chavan Payal Chavhanke. "A Review Article ON: cGmp Signaling: A Contemporary Overview and Future Direction." International Journal of Pharmaceutical Sciences 3, no. 4 (2025): 2431–37. https://doi.org/10.5281/zenodo.15257931.

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GMP (Good Manufacturing Practice) is a system for ensuring that products&ensp;are produced and controlled consistently against&ensp;quality standards. Its reduce risks in&ensp;the manufacture of pharmaceuticals, guaranteeing products&ensp;are safe, effective and high quality. GMP has four key aspects to make&ensp;this work aspect Raw Material Quality, ensures material is known, is processed, and free&ensp;from contamination;&ensp;Risk Assessment, preventing and managing risks in pharmaceutical production; Inspections,&ensp;routine inspections of manufacturing sites in terms of actions&ensp;tak

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Ullagaddi, P. "Safeguarding Data Integrity in Pharmaceutical Manufacturing." Journal of Advances in Medical and Pharmaceutical Sciences 26, no. 8 (2024): 64–75. http://dx.doi.org/10.9734/jamps/2024/v26i8708.

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Aims: Comprehensively analyze data integrity challenges in the pharmaceutical industry, analyze regulatory observations, and propose mitigation strategies for ensuring compliance with current good manufacturing practices (cGMP), particularly for electronic data and computerized systems. Study Design: Analysis of regulatory documents, industry-standard guides, and case studies. Methodology: The study involved a comprehensive review of FDA guidance documents, warning letters, and Form 483 observations related to data integrity. Case studies of non-compliance were analyzed to identify common issu

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Krychkovska, A., O. Ushkalova, L. Bolibrukh, O. Khomenko, N. Monka, and Kh Bolibrukh. "Pharmaceutical department and technologies of manufacturing of medicinal products." Chemistry, Technology and Application of Substances 5, no. 1 (2022): 67–74. http://dx.doi.org/10.23939/ctas2022.01.067.

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It was established two forms of organization of providing medicines and medical devices to patients of inpatient departments of health care facilities. The distribution of the presence of pharmacies licensed to manufacture drugs in the structure of the health care facilities by the studied regions of Ukraine was analyzed. It was established that the presence of a pharmaceutical department (pharmacy) in the structure of the departmental health care facilities allows to avoid possible risks that arise when organizing the provision of drugs by only one pharmacist in the health care facilities. It

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Ogbuagu, Oluchukwu Obinna, Akachukwu Obianuju Mbata, Obe Destiny Balogun, Olajumoke Oladapo, Opeyemi Olaoluawa Ojo, and Muridzo Muonde. "Quality assurance in pharmaceutical manufacturing: bridging the gap between regulations, supply chain, and innovations." International Journal of Multidisciplinary Research and Growth Evaluation 4, no. 1 (2023): 823–31. https://doi.org/10.54660/.ijmrge.2023.4.1-823-831.

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Quality assurance (QA) in pharmaceutical manufacturing is essential for ensuring drug safety, efficacy, and consistency. As global pharmaceutical markets expand and regulations become increasingly complex, there is a pressing need for a holistic approach to integrate regulations, supply chain resilience, and technological innovations to maintain high-quality standards. This paper explores the critical role of regulatory frameworks, such as the FDA, EMA, and GMP guidelines, in ensuring compliance across diverse markets, while addressing the challenges associated with evolving laws and documenta

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Victoria Joy Pama, Francispito Quevedo, and Venusmar Quevedo. "“Emerging Occupational Risks in a Pharmaceutical Company Under Industry 4.0: An Assessment Using TICHNER and HIRAC Tools”." International Journal of Latest Technology in Engineering Management & Applied Science 13, no. 6 (2024): 63–77. http://dx.doi.org/10.51583/ijltemas.2024.130609.

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Abstract: The integration of Industry 4.0 technologies within the pharmaceutical manufacturing sector aligns with broader industrial objectives, aiming to enhance productivity and adaptability while meeting challenging standards for product quality and diversity while maximizing efficiency. However, this shift is not risk-free. This particularly concerns the well-being of workers which is one of the top concerns shared by manufacturers. As the industry navigates this transition, it is imperative to prioritize the safety of personnel. The rapid pace of technological innovation within pharmaceut

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Rohit, Bhargav. "Risk Management in the Pharmaceutical Industry." International Educational Applied Research Journal 08, no. 11 (2024): 30–35. https://doi.org/10.5281/zenodo.14108925.

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Pharmaceutical companies operate in an environment characterized by high-stakes decisions, significant investments, and rigorous regulations. As such, effective risk management is crucial for safeguarding patient safety, ensuring regulatory compliance, and optimizing financial performance. This paper explores the multifaceted nature of risk management in the pharmaceutical industry, highlighting its frameworks, methodologies, and the significance of a proactive culture in mitigating risks associated with drug development, manufacturing, and commercialization.

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Alsaidalani, Rawidh, and Bassam Elmadhoun. "Quality Risk Management in Pharmaceutical Manufacturing Operations: Case Study for Sterile Product Filling and Final Product Handling Stage." Sustainability 14, no. 15 (2022): 9618. http://dx.doi.org/10.3390/su14159618.

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In the highly regulated pharmaceutical industry, significant risks to products/processes must be formally identified, reduced, and controlled to minimize potential negative impacts on patients. Failure Modes and Effects Analysis (FMEA) is one of the well-recognized risk-management tools which is effectively used by the pharmaceutical industry to document and communicate risk control. International Conference on Harmonization (ICH) guideline Q9, Quality Risk Management (QRM), represents the first internationally recognized guideline specifically addressing QRM for the pharmaceutical and biophar

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Neha, Chandrashekhar Patil, Sunil Patil Bhagyashri, A. Patil Sunila, and S. Patil Sulbha. "A Review on Air Based Hazard." Journal of Advances in Ayurveda, Yoga, Homeopathy and Naturopathy 2, no. 1 (2024): 27–35. https://doi.org/10.5281/zenodo.11380415.

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<em>The pharmaceutical sector plays a vital role in the development, production, distribution, and discovery of medications for human and veterinary use in healthcare systems across the globe. The purpose of this study is to identify air-based hazards that may arise from industry as well as the management of air circulation in the pharmaceutical sector. The quality of the air supplied in the industry's manufacturing or working environments affects the quality of pharmaceutic products as well. Understanding the causes and types of airborne dangers as well as how to lessen the health risks assoc

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Yasinskaya, L. E. "Comparative analysis of business models of top pharmaceutical manufacturing companies: fifi nancial analysis." Remedium Journal about the Russian market of medicines and medical equipment, no. 10 (2020): 43–52. http://dx.doi.org/10.21518/1561-5936-2020-10-43-52.

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Introduction. Earlier, the comparative analysis of the commercial and investment activities of the companies that play the key roles in the investment processes in the Russian pharmaceutical industry and operate within the four main business models (biotechnological, generic, specialized pharmaceutical companies, active pharmaceutical ingredient (API) manufacturers) has been conducted. No full assessment of the companies’ activitiesis conceivable without a financial analysis of their activities to identify the risks of investment activities. Objective of the study. A detailed comparative analy

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Ivankova, Ju O., B. B. Sysuev, and S. B. Evseeva. "The Quality Risk Assessment of Paralithodes Camtschaticus Collagenase Gel in the Process of Pharmaceutical Development." Drug development & registration 12, no. 3 (2023): 66–71. http://dx.doi.org/10.33380/2305-2066-2023-12-3-66-71.

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Introduction. The manufacturing and application of enzyme preparations in the semisolid topical products has features associated with their lability. In previous studies, on the set of specifications the gel form was selected, containing aerosil and olive oil, in which the stabilization of collagenase from Paralithodes camtschaticus was ensured by lipophilic base. In the pharmaceutical development process, the drug critical quality attributes must be defined. Taking into account the lability of Paralithodes camtschaticus collagenase, the identification and minimizing risks аre relevant.Aim. Th

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Jadhav, N. R., Sunil Bhutada, S. R. Sagavkar, Rohit Pawar, Archana Bajirao Kanwade, and Purva Mange. "AI-driven pharmaceutical manufacturing : Revolutionizing quality control and process optimization." Journal of Statistics and Management Systems 27, no. 2 (2024): 405–16. http://dx.doi.org/10.47974/jsms-1265.

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The Integrating AI into pharmaceutical production processes represents a paradigm change for the pharmaceutical sector. This article examines the role of AI in pharmaceutical production, focusing on its potential to improve productivity, cut costs, and guarantee the highest standards of product quality and safety in quality control and process optimization. AI technologies, including machine learning, computer vision, and natural language processing, are increasingly being employed to analyze large volumes of data generated throughout the pharmaceutical manufacturing lifecycle. Risks related t

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Dzerzhinskaya, A. A., A. A. Spiridonova, and E. G. Khomutova. "Systematic approach to cross-contamination risk management in the production of medicinal products." Drug development & registration 11, no. 1 (2022): 149–58. http://dx.doi.org/10.33380/2305-2066-2022-11-1-149-158.

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Introduction. Good Manufacturing Practice (GMP) requires drug manufacturers to apply risk management principles in their operations. One of the main risks to the quality and safety of pharmaceuticals is cross-contamination. The introduction of a systematic approach to contamination risk management requires manufacturers to make a comprehensive assessment of both production processes and the organization of production sites (premises, equipment, systems, etc.). Therefore, the transition to the current GMP requirements for operating production sites may require significantly higher financial and

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Khan, Mohd Faheem. "Fungi for Sustainable Pharmaceutical Remediation: Enzymatic Innovations, Challenges, and Applications—A Review." Processes 13, no. 4 (2025): 1034. https://doi.org/10.3390/pr13041034.

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The extensive use of pharmaceuticals in human and veterinary medicine has led to their persistent environmental release, posing ecological and public health risks. Major sources include manufacturing effluents, excretion, aquaculture, and improper disposal, contributing to bioaccumulation and ecotoxicity. Mycoremediation is the fungal-mediated biodegradation of pharmaceuticals, offers a promising and sustainable approach to mitigate pharmaceutical pollution. Studies have reported that certain fungal species, including Trametes versicolor and Pleurotus ostreatus, can degrade up to 90% of pharma

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Keezhadath, Arun Ayilliath, and Lalitha Amarapalli. "Ensuring Data Integrity in Pharmaceutical Quality Systems: A Risk-Based Approach." Journal of AI-Powered Medical Innovations (International online ISSN 3078-1930) 1, no. 1 (2024): 83–104. https://doi.org/10.60087/japmi.vol01.issue01.p104.

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The integrity of data within pharmaceutical quality systems is crucial to ensuring product quality, patient safety, and regulatory compliance. This paper presents a risk-based approach to safeguarding data integrity across pharmaceutical quality systems. It discusses the regulatory frameworks, industry best practices, and the potential risks associated with data manipulation, loss, or corruption. By applying risk assessment tools, the paper outlines strategies for identifying vulnerable points in data management processes and proposes corrective actions to mitigate these risks. Furthermore, it

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Moradeyo, Adenike Aderonke. "Rudimentary causes and impacts of supply chain risks in Sub-Saharan Africa." Journal of Operations and Supply Chain Management 11, no. 2 (2018): 16. http://dx.doi.org/10.12660/joscmv11n2p16-31.

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<p>Identification of the causes of supply chain risks is a logical step towards its effective management. The purpose of this study is to explore the causes of supply chain risks, their impacts, and the mitigating strategies used among the manufacturing firms in Nigeria. An exploratory qualitative multiple case research methodology combined with the quantitative content analysis is used for this study. A sample of ten manufacturing firms cutting across three different sub-sectors (Pharmaceutical &amp; Health, Food &amp; Beverage, and Conglomerate) was chosen for the study. Partia

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Moktadir, Md Abdul, Syed Mithun Ali, Sachin Kumar Mangla, et al. "Decision modeling of risks in pharmaceutical supply chains." Industrial Management & Data Systems 118, no. 7 (2018): 1388–412. http://dx.doi.org/10.1108/imds-10-2017-0465.

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Purpose Managing risks is becoming a highly focused activity in the health service sector. In particular, due to the complex nature of processes in the pharmaceutical industry, several risks have been associated to its supply chains. The purpose of this paper is to identify and analyze the risks occurring in the supply chains of the pharmaceutical industry and propose a decision model, based on the Analytical Hierarchy Process (AHP) method, for evaluating risks in pharmaceutical supply chains (PSCs). Design/methodology/approach The proposed model was developed based on the Delphi method and AH

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Shinde, Prajwal S., Ashish Y. Pawar, and Swati G. Talele. "The Role of Artificial Intelligence in the Pharmaceutical Sector: A Comprehensive Analysis of its Application from the Discovery Phase to Industrial Implementation." INTERNATIONAL JOURNAL OF DRUG DELIVERY TECHNOLOGY 13, no. 04 (2023): 1283–86. http://dx.doi.org/10.25258/ijddt.13.4.70.

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The incorporation of artificial intelligence (AI) technology into the pharmaceutical sector is a groundbreaking revolution, promising to enhance drug development significantly by boosting speed, efficiency, and effectiveness. This transformative journey encompasses several key facets, notably the sophisticated analysis of complex data, the optimization of drug delivery systems, the acceleration of drug discovery, the identification of valuable biomarkers and drug candidates, and the fine-tuning of treatment outcomes. Beyond these crucial strides, AI is reshaping healthcare at large, elevating

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Sahaidak-Nikitiuk, Rita, Karyna Holybtsova, Nataliya Demchenko, and Vitalii Nikitiuk. "Directions for improving adaptive management efficiency of manufacturing pharmaceutical companies." EUREKA: Health Sciences, no. 5 (September 30, 2021): 61–68. http://dx.doi.org/10.21303/2504-5679.2021.002052.

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The aim of the article is to analyze the existing problems of adaptive management of manufacturing pharmaceutical companies and the development of methodological support for their management. Materials and methods. The research used methods of theoretical generalization, analysis and synthesis, synergetic approach and expert survey. 120 people were involved in the expert survey, divided into four groups: representatives of pharmaceutical manufacturing enterprises (30 people); representatives of pharmaceutical higher education institutions (30 people); pharmaceutical distributors re

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Sahaidak-Nikitiuk, Rita, Karyna Holybtsova, Nataliya Demchenko, and Vitalii Nikitiuk. "Directions for improving adaptive management efficiency of manufacturing pharmaceutical companies." EUREKA: Health Sciences, no. 5 (September 30, 2021): 61–68. https://doi.org/10.21303/2504-5679.2021.002052.

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The aim of the article is to analyze the existing problems of adaptive management of manufacturing pharmaceutical companies and the development of methodological support for their management. Materials and methods. The research used methods of theoretical generalization, analysis and synthesis, synergetic approach and expert survey. 120 people were involved in the expert survey, divided into four groups: representatives of pharmaceutical manufacturing enterprises (30 people); representatives of pharmaceutical higher education institutions (30 people); pharmaceutical distributors representing w

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Cui, Yiyang. "Impact of Foreign Exchange on Supply Chain of the Logistics Industry." BCP Business & Management 45 (April 27, 2023): 307–12. http://dx.doi.org/10.54691/bcpbm.v45i.4936.

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China is the world's largest manufacturing country, the most important link in the global industrial chain, and the world's second largest consumer market after the United States. China's manufacturing industry has also been affected by the epidemic, and its transformation and upgrading have been affected. China's total manufacturing industry has occupied the world's top position for many years in a row, becoming an indispensable link in the global production chain. In the situation of global manufacturing shift, some labor-intensive industries are gradually moving out of China as the cost of

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Pathodiya, Manish. "Cross-contamination Risk Assessment using FMEA tool." Journal of Drug Delivery and Therapeutics 14, no. 9 (2024): 164–67. http://dx.doi.org/10.22270/jddt.v14i9.6765.

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In pharmaceutical manufacturing facilities, products with different therapeutic properties and potencies are manufactured in shared spaces, which poses a potential risk for cross-contamination. During the manufacturing process, cross-contamination may occur due to the uncontrolled release of dust, gases/vapors, mix-ups with other materials, residues on equipment, and contamination from operator’s clothing. By implementing adequate facility design and manufacturing operations aligned with Quality Risk Management principles, the risk of cross-contamination can be controlled. If a shared facility

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Zhurenko, Victoriia, and Viacheslav Lebedynets. "Determination of risks for business entities in the sphere of manufacturing medicines in military conditions in Ukraine." ScienceRise: Pharmaceutical Science, no. 5(45) (October 31, 2023): 32–43. http://dx.doi.org/10.15587/2519-4852.2023.289981.

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The aim: determination of risks for business entities in the field of production of medicinal products under the conditions of martial law in Ukraine. Materials and methods. The research materials are the results of a sociological survey in the form of a questionnaire among representatives of the senior management heads of structural units related to the environmental component of business entities' activities in the pharmaceutical production field. Method of sociological survey was used to collect primary information. A questionnaire was conducted, and respondent’s answers were register

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R Ghanwat, Aishwarya, Kumudini R Pawar, Krutika S Nilwani, Shital P Narwade, and Pratibha L Ayanar. "A Review on Thermal and Electrical Hazards in the Pharmaceutical Industry." International Journal of Research and Review 12, no. 1 (2025): 415–26. https://doi.org/10.52403/ijrr.20250150.

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Thermal and electrical hazards in the pharmaceutical industry pose a significant risk to operational safety, product integrity, and regulatory compliance. These risks arise from the high-temperature processes of exothermic reactions, electrostatic discharge, and electrical system malfunctions. As advanced technologies in continuous manufacturing and high-speed automation are increasingly integrated, the complexity and magnitude of these hazards are accelerating. According to research findings, thermal and electrical breakdowns represent over 60% of accidents in this sector, an aspect that emph

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Haider, Rehan. "Pharmaceutical Product Liability." Dermatology and Dermatitis 9, no. 4 (2024): 01–08. http://dx.doi.org/10.31579/2578-8949/156.

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Pharmaceutical crop liability contains the permissible responsibility of drug associations for the safety and efficiency of their output. In the context of healthcare, place cures play a pivotal function in the situation, and the ramifications of drug brand liability are deep. This responsibility extends to differing stakeholders, including drug manufacturers, distributors, and consistent healthcare professionals. Key determinants in determining liability include production defects, inadequate warnings or demands, and breaches of supervisory standards. Adverse belongings, surprising risks, or

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Aleksievska Beldedovska, Katerina, Jelena Acevska, Aneta Dimitrovska, and Miroslava Ilievska. "Challenges of manufacturing site in batch certification and release in European Union." Macedonian Pharmaceutical Bulletin 65, no. 2 (2019): 3–9. http://dx.doi.org/10.33320/maced.pharm.bull.2019.65.02.001.

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A comprehensively designed Pharmaceutical Quality System (PQS) incorporating Good Manufacturing Practice and Quality Risk Management implemented, maintained and continuously improved, allows a consistent delivery of products with appropriate quality attributes. The manufacturer in the third country and the batch certification and release site in EU belong to the same organization operating under a corporate Pharmaceutical Quality System. A signed Quality Agreement between both parties provides improvement of the Pharmaceutical Quality System and continual maintenance of the quality of the medi

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Graham, John. "Factors influencing the creation of an industry 4.0 strategy in the generic pharmaceutical industry." Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector 20, no. 1 (2024): 28–46. http://dx.doi.org/10.1177/17411343241238178.

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This study aims to identify how technological, organizational, and environmental factors influence the creation of an Industry 4.0 (I4.0) strategy in the generic pharmaceutical manufacturing industry. In this study, the technology-organization-environment (TOE) framework is used to explore the factors that influence the creation of an I4.0 strategy in generic pharmaceutical manufacturing organizations. A semi-structured interview case study approach was used to gather data from a generic pharmaceutical company using the company’s creation of a digital strategy as the focus of analysis. The stu

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Xiaoming Deng, Yande Wang, Hui Chen, Xiang Zhou, Wei Xie,. "Assessing Audit Risks in Enterprises on the Growth Enterprise Market: A Grounded Theory Approach." Journal of Electrical Systems 20, no. 4s (2024): 287–96. http://dx.doi.org/10.52783/jes.1914.

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This paper adopts the research method of grounded theory, based on the annual report audit of 66 pharmaceutical manufacturing enterprises on the Growth Enterprise Market, exchange supervision and inquiry letters, the CSRC penalty announcement and online public comment materials, and based on the actual situation, to study the audit risk of pharmaceutical enterprises on the Growth Enterprise Market. . The study found that the misstatement risk of pharmaceutical companies on the GEM is divided into the overall level and the specific level. Among them, the overall misstatement is related to the e

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Sumukha Krishna P, Gangadharappa H V, Nagendra S, and Hemanth Kumar S. "An Overview of Risk Management and Risk-based Cleaning Validation." International Journal of Research in Pharmaceutical Sciences 11, no. 4 (2020): 5407–14. http://dx.doi.org/10.26452/ijrps.v11i4.3168.

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Risk in general means exposure to harm or a factor that can contribute towards bringing harm to a system. Almost every operation in the pharmaceutical industry is susceptible to risks. There is a need to overcome risks and them to prevent unwanted changes in product quality and safety. This prevention can be done by carrying out quality risk management (QRM) that facilitates the proper of risks, risk analysis, risk assessment to control and reduce risks. ICH Q9 guidelines explain quality risk management and its applications in the pharmaceutical industry. Cleaning validation is performed to ve

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Veliyath, Rajaram. "Business Risk And Performance: An Examination Of Industry Effects." Journal of Applied Business Research (JABR) 12, no. 3 (2011): 38. http://dx.doi.org/10.19030/jabr.v12i3.5798.

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<span>Both business risk and industry sales volatility decreased across the computing equipment manufacturing, airline and pharmaceutical industries. Earnings performance and industry environmental munificence were both the highest among airlines. High volatility, while posing greater business risks, also offered the opportunity for improved risk-performance payoffs in the computer industry. Individual firms in the computer and pharmaceutical industries successfully reduced business risk while simultaneously increasing earnings performance (i.e., negative within-firm correlations), indic

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Katta, Srikanth Reddy, and Sudheer Devaraju. "Efficient data normalization for maintenance and calibration records in pharma manufacturing facilities." International Journal of Multidisciplinary Research and Growth Evaluation 3, no. 5 (2022): 607–14. https://doi.org/10.54660/.ijmrge.2022.3.5.607-614.

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In pharmaceutical manufacturing areas, proper documentation of maintenance and calibration activities is an important aspect because it has to meet legal requirements, including GMP. Data normalisation is an important aspect of managing and transforming maintenance data into easily searchable, well-formatted, and efficient data for use. In this paper, we develop a detailed methodology for data normalisation, especially for use in pharmaceutical maintenance and calibration records. Normalisation entails the mapping of keys and tables to reduce the duplicity of data and the use of structured tem

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Saxena, Himani, R. S. Mishra, and A. K. Madan. "Performance Measurement of Flexible Manufacturing System in Context to Bareilly Camphor Industry." International Journal of Advance Research and Innovation 8, no. 2 (2020): 121–24. http://dx.doi.org/10.51976/ijari.822021.

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FMS is a manufacturing system in which there is flexibility that allows the system to react to changes, whether predicted or unpredicted. It is a highly integrated manufacturing system. Oriental Aromatics Ltd. (Formerly Camphor and Allied Prod. Ltd.) is a completely integrated flavour, fragrance and aroma chemical manufacturing companies in the world today. Its three manufacturing centers are spread across the west and north of India, in Ambernath in Maharashtra, Baroda in Gujarat and Bareilly in Uttar Pradesh. It manufactures synthetic camphor, which can be utilised in several different ways.

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K., Swathi*. P. Sai Pratyusha D. Kalyani U. Madhavi. "Water Quality Monitoring In SPMVV By IOT Tools." International Journal in Pharmaceutical Sciences 2, no. 4 (2024): 178–91. https://doi.org/10.5281/zenodo.10913301.

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Water plays a crucial role in the pharmaceutical industry, influencing both product quality and manufacturing process.. The effects of low-quality water in the pharmaceutical industry are far-reaching, impacting product quality, and operational efficiency. To mitigate these risks, pharmaceutical companies must implement robust water quality monitoring and purification systems to ensure that the water used in manufacturing meets the required standards and specifications. There are different techniques used for purification of water in pharmaceutical industry and also using different parameters

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Agarwal, Princy, Anju Goyal, and Rajat Vaishnav. "CHEMICAL HAZARDS IN PHARMACEUTICAL INDUSTRY: AN OVERVIEW." Asian Journal of Pharmaceutical and Clinical Research 11, no. 2 (2018): 27. http://dx.doi.org/10.22159/ajpcr.2018.v11i2.23160.

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The pharmaceutical industry is a vital component of health-care systems all over the world engaged in discovery, development, manufacture, and marketing of medicines for human as well as animal health. Pharmaceutical industries also have many environmental problems, like the other chemical industries. The pharmaceutical industry is based primarily on the scientific formulation, research, and development of drugs, that is, helpful in the prevention or treatment of diseases and disorders. The manufacturing of APIs and formulation processes involves the use of various chemicals which includes var

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Kurnianto, Arie Arizandi, Reski Syamsu, Peter Thokozani Phiri, and Josfirin Uding Rangga. "Occupational Health Risk Management in Tablet Manufacturing: A Case Study of Non-Beta Lactam and Penicillin Production Units." Environmental Research and Planetary Health 1, no. 1 (2025): 8–17. https://doi.org/10.53623/erph.v1i1.539.

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Background: In the pharmaceutical tablet manufacturing industry, health risks involve high occupational health risks, especially in handling active pharmaceutical ingredients (APIs). This research addresses the challenge that effective risk management is essential to safeguard worker health, particularly in the production of critical products such as Non-Beta Lactams (NBL) and Penicillin. Objective: evaluating and investigating occupational health risks in the NBL and Penicillin production units, identifying key risk factors and proposing strategies to reduce exposure. Methods: This study used

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N.Patil,, Amruta. "A Comprehensive Review on Drug Impurities: Types, Risks, and Analytical Methods." INTERANTIONAL JOURNAL OF SCIENTIFIC RESEARCH IN ENGINEERING AND MANAGEMENT 09, no. 03 (2025): 1–9. https://doi.org/10.55041/ijsrem42219.

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Drug impurities are unwanted substances that may be present in pharmaceutical products, arising from raw materials, manufacturing processes, or degradation over time. These impurities can affect the safety, efficacy, and quality of drugs, posing potential risks to patient health. This review explores the various types of drug impurities, including process-related impurities, degradation products, residual solvents, excipient impurities, and microbiological contaminants. The impact of these impurities on drug toxicity, efficacy, stability, and regulatory compliance is also discussed. Furthermor

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Alkesh, S. Mourya, and Rajesh Kumar Pandey Dr. "A Study on Factors Attributed to Failure of Pharmaceutical Products." Applied Science and Biotechnology Journal for Advanced Research 3, no. 2 (2024): 12–21. https://doi.org/10.5281/zenodo.10976869.

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The Pharmaceutical Industry plays a pivotal role in healthcare by developing, manufacturing, and marketing drugs to treat a myriad of medical conditions. However, despite rigorous research, development, and testing processes, a significant number of pharmaceutical products fail to meet the expected standards or gain market acceptance. This study aims to explore the multifaceted factors that contribute to the failure of pharmaceutical products, focusing on the product life cycle as a framework for analysis. The product life cycle of a pharmaceutical product encompasses several stages, including

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Bouzidi, Abdelbasset, Imad Eddine Bedaida, and Wissam Belimane. "Risk Management Applying FMECA in Pharmaceutical Packaging Production: Implementation of ISO 15378:2017 – Case Study." Timisoara Journal of Economics and Business 18, no. 1 (2025): 95–112. https://doi.org/10.2478/tjeb-2025-0005.

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Abstract The quality of primary pharmaceutical packaging materials is crucial to ensure product safety and regulatory compliance. This study aims to apply the FMECA (Failure Mode, Effects and Criticality Analysis) method to manage risks and improve the production process of pharmaceutical packaging at CENTRA MED, a company in Algeria specialised in the manufacturing of primary packaging for the pharmaceutical and medical industries. The study is part of a project to achieve certification to the ISO 15378:2017 standard. In this case, we adopted a qualitative method based on a research-action ap

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Ogadah, Cletus Okechukwu, Izuchukwu Prince Nweke, Konstantin Koshechkin, et al. "Digital Transformation in Pharmaceutical Operations: A Comprehensive Review of Industrial Internet of Things (IIoT) Applications." Asian Journal of Research in Medical and Pharmaceutical Sciences 14, no. 3 (2025): 1–17. https://doi.org/10.9734/ajrimps/2025/v14i3313.

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Background: The Industrial Internet of Things (IIoT) connects devices, sensors, and advanced analytics systems within industrial settings to optimize operations, enhance data visibility, and support real-time decision-making. In the pharmaceutical industry, IIoT is becoming a transformative technology, aligning with the broader Industry 4.0 framework to improve operational efficiency, adaptability, and regulatory compliance in an industry characterized by stringent quality and safety standards designed and enforced on bioprocessing industries by Regulatory bodies such as the FDA and EMA. Objec

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L. Parapalli, Shriprakashan. "21 CFR Part 11 Compliance in MES: Electronic Signatures and Data Integrity." International journal of networks and security 05, no. 01 (2025): 187–201. https://doi.org/10.55640/ijns-05-01-11.

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In pharmaceutical manufacturing, compliance with 21 CFR Part 11 is critical for ensuring the integrity of electronic records and signatures within Manufacturing Execution Systems (MES). This paper proposes a comprehensive framework for implementing electronic signatures and data integrity controls in MES, aligning with 21 CFR Parts 11, 210, 211, ICH Q7, and EudraLex Volume 4 Annex 11. The methodology includes system design, user access controls, audit trails, and data lifecycle management, validated through risk-based assessments. Key findings demonstrate that tailored electronic signature con

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Manjunath D.N., Shailesh T., and Gowrav M.P. "Annual Product Quality Review." International Journal of Research in Pharmaceutical Sciences 11, no. 2 (2020): 1862–69. http://dx.doi.org/10.26452/ijrps.v11i2.2094.

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Annual Product Quality Review (APQR) is an estimation prepared according to the Current Goods Manufacturing Practice (CGMP) requirements of different regulatory authorities. A Goods Manufacturing Practice (GMP) ensures that the products are constantly produced and controlled according to quality standards. APQR is not only required for GMP but also required for the quality improvement of the pharmaceutical product. APQR is an evaluation carried out annually to measure the standard of quality of each drug with an intention to verify the constancy of current process and to check the correctness

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Zagare, Shreyas, Prof Manish Khodaskar, Yash Sonawane, and Harish Verma. "Counterfeit Medicine Detection using Blockchain." International Journal of Soft Computing and Engineering 14, no. 2 (2024): 5–11. http://dx.doi.org/10.35940/ijsce.c3634.14020524.

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The healthcare industry has grappled with the challenge of monitoring genuine medicines while counterfeit drugs continue to proliferate, posing significant risks to patient safety. These fraudulent pharmaceuticals not only have detri- mental effects on health but also result in substantial financial losses, with reports indicating annual losses of approximately 200 billion dollars for US pharmaceutical companies. Particu- larly concerning is the World Health Organization’s revelation that in underdeveloped nations, one in every ten medicines consumed by patients is counterfeit and of low quali

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Zagare, Shreyas, Prof Manish Khodaskar, Yash Sonawane, and Harish Verma. "Study of Fake Medicine Detection using Blockchain." International Journal of Inventive Engineering and Sciences 11, no. 4 (2024): 1–4. http://dx.doi.org/10.35940/ijies.f8017.11040424.

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The healthcare industry has grappled with the challenge of monitoring genuine medicines while counterfeit drugs continue to proliferate, posing significant risks to patient safety. These fraudulent pharmaceuticals not only have detri-mental effects on health but also result in substantial financial losses, with reports indicating annual losses of approximately 200 billion dollars for US pharmaceutical companies. Particu-larly concerning is the World Health Organization’s revelation that in underdeveloped nations, one in every ten medicines consumed by patients is counterfeit and of low quality

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Harish, Verma. "Study of Fake Medicine Detection using Blockchain." International Journal of Inventive Engineering and Sciences (IJIES) 11, no. 4 (2024): 1–4. https://doi.org/10.35940/ijies.F8017.11040424.

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<strong>Abstract:</strong> The healthcare industry has grappled with the challenge of monitoring genuine medicines while counterfeit drugs continue to proliferate, posing significant risks to patient safety. These fraudulent pharmaceuticals not only have detri-mental effects on health but also result in substantial financial losses, with reports indicating annual losses of approximately 200 billion dollars for US pharmaceutical companies. Particu-larly concerning is the World Health Organization’s revelation that in underdeveloped nations, one in every ten medicines consumed by patients

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