Relevant bibliographies by topics / Pharmaceutical Manufacturing Risks

Contents

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

Academic literature on the topic 'Pharmaceutical Manufacturing Risks'

Author: Grafiati
Published: 2 June 2025
Last updated: 31 July 2025

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Journal articles on the topic "Pharmaceutical Manufacturing Risks"

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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 are produced and controlled consistently against quality standards. Its reduce risks in the manufacture of pharmaceuticals, guaranteeing products are safe, effective and high quality. GMP has four key aspects to make this work aspect Raw Material Quality, ensures material is known, is processed, and free from contamination; Risk Assessment, preventing and managing risks in pharmaceutical production; Inspections, routine inspections of manufacturing sites in terms of actions 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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Dissertations / Theses on the topic "Pharmaceutical Manufacturing Risks"

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Chen, Emily M. Eng Massachusetts Institute of Technology. "Manufacturing risk assessment and uncertainty analysis for early stage (Pre-phase III) pharmaceutical drug production." Thesis, Massachusetts Institute of Technology, 2017. http://hdl.handle.net/1721.1/112872.

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Thesis: M. Eng. in Supply Chain Management, Massachusetts Institute of Technology, Supply Chain Management Program, 2017.<br>Cataloged from PDF version of thesis.<br>Includes bibliographical references (pages 40-41).<br>Supply chains in the pharmaceutical industry are growing increasingly more complex and expanding their geographic reach both in manufacturing production and to the end consumer, the patient. Physical development, manufacturing and distribution of these drugs, both of biologics and small molecules, is extremely technical in science and processes. Additionally, the industry is hi
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Mohammed, Warda. "Optimizing Sample Dissolution Methods of Low Water Soluble Intermediate Organic Compounds to Support Environmental Risk Assessment during Active Pharmaceutical Ingredient Manufacturing." Thesis, Örebro universitet, Institutionen för naturvetenskap och teknik, 2021. http://urn.kb.se/resolve?urn=urn:nbn:se:oru:diva-93416.

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This project focus on investigating the dissolution of low water-soluble intermediate organic compounds called active pharmaceutical ingredients (API) and organic substances that are manufactured by a pharmaceutical company, Cambrex Karlskoga in Sweden. Several dissolution methods were used and evaluated using methods including total organic carbon (TOC), chemical oxygen demand (COD), biochemical oxygen demand (BOD) and Microtox toxicity test. The selection of solvents were based on previous studies and specifications from the Swedish Institute of Standards, SIS.The performance of eight solven
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Lopes, Maria Sofia de Trigueiros Pinção Henriques. "Critical parameters in manufacturing process validation of different forms of pharmaceutical injectable products to assess products´ risk framework." Master's thesis, 2013. http://hdl.handle.net/10451/25011.

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Tese de mestrado, Engenharia Farmacêutica, Universidade de Lisboa, Faculdade de Farmácia, 2014<br>The main goal of this work was to create a valuable Risk Management Approach that enables a Process Validation over products lifecycle. Quality risk management (QRM) has been described in regulatory guidance for several aspects of process validation, such as product lifecycle, extent of validation, determination of critical quality attributes (CQAs) and critical process parameters (CPPs), process design space (DS), and sampling plans and statistical confidence levels. Verification of the process i
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Books on the topic "Pharmaceutical Manufacturing Risks"

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Mollah, A. Hamid, Mike Long, and Harold S. Baseman, eds. Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing. John Wiley & Sons, Inc., 2013. http://dx.doi.org/10.1002/9781118514399.

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Rannow, Sven. Managing Protected Areas in Central and Eastern Europe Under Climate Change. Springer Nature, 2014.

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Risk Management Applications In Pharmaceutical And Biopharmaceutical Manufacturing. John Wiley & Sons, 2012.

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Long, Mike, Hamid Mollah, and Harold Baseman. Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing. Wiley & Sons, Limited, John, 2013.

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Long, Mike, Hamid Mollah, and Harold Baseman. Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing. Wiley & Sons, Incorporated, John, 2013.

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Long, Mike, Hamid Mollah, and Harold Baseman. Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing. Wiley & Sons, Incorporated, John, 2013.

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Long, Mike, Hamid Mollah, and Harold Baseman. Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing. Wiley & Sons, Incorporated, John, 2013.

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Long, Mike, Hamid Mollah, and Harold Baseman. Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing. Wiley & Sons, Incorporated, John, 2013.

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Viles, Jill Dopf. Manufacturing My Miracle. Bloomsbury Academic, 2025. https://doi.org/10.5040/9798881846145.

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Who lives? Who dies? Who decides? One woman's quest to save her family from a rare hereditary disorder and what it means for our collective genetic future Jill Dopf Viles's genetic detective story takes readers on an extraordinary journey of scientific discovery, personal determination, and bioethical debate. From childhood, Jill knew her body was different - her muscles were weak, her tendons tight, and her body fat nearly absent. When doctors failed to diagnose her condition, she became her own researcher, diving deep into genetics in her search for answers. Nearly thirty years ago, Jill Vil
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Managing Protected Areas In Central And Eastern Europe Under Climate Change. Springer, 2014.

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Book chapters on the topic "Pharmaceutical Manufacturing Risks"

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Raschiatore, Marlene. "Pharmaceutical Product Manufacturing." In Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing. John Wiley & Sons, Inc., 2013. http://dx.doi.org/10.1002/9781118514399.ch11.

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Ahmed, Ruhi, and Thomas Genova. "Biopharmaceutical Manufacturing." In Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing. John Wiley & Sons, Inc., 2013. http://dx.doi.org/10.1002/9781118514399.ch12.

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Near, Joseph C. "Quality Management Systems and Risk Management." In Good Manufacturing Practices for Pharmaceuticals. CRC Press, 2019. http://dx.doi.org/10.1201/9781315120669-2.

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Walker, Mark, and Thomas Busmann. "Risk Management Tools." In Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing. John Wiley & Sons, Inc., 2013. http://dx.doi.org/10.1002/9781118514399.ch2.

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Long, Mike. "Risk Management: Regulatory Expectation, Risk Perception, and Organizational Integration." In Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing. John Wiley & Sons, Inc., 2013. http://dx.doi.org/10.1002/9781118514399.ch3.

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Ginsbury, Karen S. "Process Development and Clinical Product Manufacturing." In Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing. John Wiley & Sons, Inc., 2013. http://dx.doi.org/10.1002/9781118514399.ch6.

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Harclerode, William, Bob Moser, Jorge A. Ferreira, and Christophe Noualhac. "Risk-Based Change Control." In Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing. John Wiley & Sons, Inc., 2013. http://dx.doi.org/10.1002/9781118514399.ch13.

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Long, Mike. "Statistical Topics and Analysis in Risk Assessment." In Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing. John Wiley & Sons, Inc., 2013. http://dx.doi.org/10.1002/9781118514399.ch4.

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Jose, Jerrish A., Deepak Sharan, and Joshua Samuel Rajkumar. "Analysis of Ergonomic Risk Factors in a Pharmaceutical Manufacturing Company." In Advances in Intelligent Systems and Computing. Springer International Publishing, 2018. http://dx.doi.org/10.1007/978-3-319-96068-5_39.

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Baseman, Harold S., and A. Hamid Mollah. "Background and Introduction." In Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing. John Wiley & Sons, Inc., 2013. http://dx.doi.org/10.1002/9781118514399.ch1.

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Conference papers on the topic "Pharmaceutical Manufacturing Risks"

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VIVAR, Indra CASTRO, Catherine AZZARO-PANTEL, Alberto A. AGUILAR LASSERRE, and Fernando MORALES-MENDOZA. "Eco-Designing Pharmaceutical Supply Chains: A Process Engineering Approach to Life Cycle Inventory Generation." In The 35th European Symposium on Computer Aided Process Engineering. PSE Press, 2025. https://doi.org/10.69997/sct.185378.

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The environmental impacts of pharmaceutical production underscore the need for comprehensive life cycle assessments (LCAs). Offshoring manufacturing, a common cost-saving strategy in the pharmaceutical industry, increases supply chain complexity and reliance on countries like India and China for active pharmaceutical ingredients (APIs). The COVID-19 pandemic exposed Europe�s vulnerability to global crises, prompting initiatives such as the French government�s re-industrialization plan to relocate the production of fifty critical drugs. Paracetamol production has been prioritized, with recent s
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Velјanova Martinoski, Elena. "QUALITY RISK MANAGEMENT - REGULATORY FRAMEWORK." In XX International Convention on Quality JUSK ICQ 2024. United Association of Serbia for Quality, 2024. http://dx.doi.org/10.46793/jusk-icqxx.058vm.

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t is known that at the time of drug safety approval, the amount of information is relatively limited. We are all witnessing a time when everything is very dynamic, a time of complete digitization and automation, where information’s are easily available. Additionally, the COVID-19 virus pandemic has forced rapid drug development and easy availability of drugs for patients. Dynamics carries many risks, so risk management techniques, although well known to the pharmaceutical industry, are becoming an increasingly popular and used tool. Risk management regulation is defined in EU and FDA quality g
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Sturgeon, I. L., and J. B. Thomson. "Application of Best Practice Manufacturing Methodologies to Support Achievement of Planned Decommissioning Timescales and Costs." In ASME 2003 9th International Conference on Radioactive Waste Management and Environmental Remediation. ASMEDC, 2003. http://dx.doi.org/10.1115/icem2003-4625.

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The decommissioning of major nuclear plant facilities will inevitably involve a number of project areas where significant levels of processing and manufacturing tasks are required. Typically this includes key task areas such as: • ILW materials retrievals and handling; • ILW / LLW materials processing and encapsulation; • Contaminated surfaces remediation; • Import of materials at dedicated ILW Stores. All such areas involve a series of high level project stages: 1) Design, install and commission facilities; 2) Operate facilities to complete the project tasks (retrievals, processing etc); 3) P
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Fritsch, Klaus. "GWP® - The Science-Based Global Standard for Efficient Lifecycle Management of Weighing Systems." In NCSL International Workshop & Symposium. NCSL International, 2012. http://dx.doi.org/10.51843/wsproceedings.2012.22.

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In the pharmaceutical laboratory, weighing is only one step of a whole analysis chain in drug discovery and quality control; however it strongly influences the overall quality and integrity of the final result. Also in production, weighing is decisive to achieve batch uniformity and consistency, e.g. in dispensing or formulation processes. For the food industry, accurate weighing processes also act as an important contribution for two of its most demanding challenges: Increasing public health and consumer safety, and increasing productivity and competitiveness. The same or similar issues are a
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Domanjko, Žan, and Igor Perko. "Artificial Intelligence Effects on Inventory Planning of Sensitive Products." In Challenges in Economics and Business in the Post-COVID Times. University of Maribor Press, 2022. http://dx.doi.org/10.18690/um.epf.5.2022.42.

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Pharmaceutical companies invested heavily in research and development, nowadays their funds are mostly allocated in the supply chain management. Inventory forecasting using AI focuses on optimising supply chain processes and mitigating operational risks related to the treatment of sensitive products. The purpose of this research is to comprehensively examine the processes and important factors that influence the implementation of forecasting and optimising inventories. The objectives identify data sources, examine data information flows, review appropriate forecasting models and analyse invent
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Fritsch, Klaus. "GWP® - The Weighing Standard: Why We Should Challenge the Established Way We Calibrate and Test Weighing Instruments." In NCSL International Workshop & Symposium. NCSL International, 2013. http://dx.doi.org/10.51843/wsproceedings.2013.35.

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In the pharmaceutical laboratory, weighing is only one step of a whole analysis chain in drug discovery and quality control; however it strongly influences the overall quality and integrity of the final result. Also in production, weighing is decisive to achieve batch uniformity and consistency, e.g. in dispensing or formulation processes. For the food industry, accurate weighing processes also act as an important contribution for two of its most demanding challenges: Increasing public health and consumer safety, and increasing productivity and competitiveness. The same or similar issues are a
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Schmitt, Paul, Heinz Bodo Seifert, Mario Bijelic, Krzysztof Pennar, Jerry Lopez, and Felix Heide. "Introducing the ML FMEA." In WCX SAE World Congress Experience. SAE International, 2025. https://doi.org/10.4271/2025-01-8078.

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&lt;div class="section abstract"&gt;&lt;div class="htmlview paragraph"&gt;Several challenges remain in deploying Machine Learning (ML) into safety critical applications. We introduce a safe machine learning approach tailored for safety-critical industries including automotive, autonomous vehicles, defense and security, healthcare, pharmaceuticals, manufacturing and industrial robotics, warehouse distribution, and aerospace. Aiming to fill a perceived gap within Artificial Intelligence and ML standards, the described approach integrates ML best practices with the proven Process Failure Mode &am
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TSINTAVI, E. "A deep learning approach for automated inspection of 3D printed orodispersible films." In Innovative Manufacturing Engineering and Energy. Materials Research Forum LLC, 2024. https://doi.org/10.21741/9781644903377-3.

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Abstract. This work aims at demonstrating the applicability of additive manufacturing and machine vision technologies for the on-demand manufacture of customized medicinal products at the point of need, while conforming to fundamental quality guidelines such as cGood Manufacturing Practices (cGMPs), Quality by Design (QbD) as well as Quality Risk Management (QRM) and assuring product quality. The adopted approach combines a 3D printing process for orodispersible films and a deep neural network model in order to develop an automated quality control system for defect detection. The orodispersibl
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Mascaro, Seth, Alexander Mueninghoff, Vedang Chauhan, and David A. Guerra-Zubiaga. "Simulation and Validation of Material Handling and Packaging Processes Using Vision-Guided Virtual and Physical Robots." In ASME 2023 International Mechanical Engineering Congress and Exposition. American Society of Mechanical Engineers, 2023. http://dx.doi.org/10.1115/imece2023-113159.

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Abstract Due to a shortage of labor, there has been a significant increase in the demand for automation and robotics in recent times. Industry 4.0 is heavily reliant on utilizing these robots to automate various processes in manufacturing to improve efficiency and reduce costs. The goal of this research is to implement automated product handling and packing using both virtual and physical robots and evaluate the performance of the system. The principal scope of this work is to automate the product handling and packaging process for a pharmaceutical company that produces pipets, thereby reducin
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Pandit, Priyanka, Arjun Earthperson, Alp Tezbasaran, and Mihai A. Diaconeasa. "A Quantitative Approach to Assess the Likelihood of Supply Chain Shortages." In ASME 2021 International Mechanical Engineering Congress and Exposition. American Society of Mechanical Engineers, 2021. http://dx.doi.org/10.1115/imece2021-73696.

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Abstract We define supply chains (SCs) as sequences of processes that link the demand and supply of goods or services within a network. SCs are prone to shortages in delivering their output goals due to several factors such as personnel undersupply, inefficient processes, policy failure, equipment malfunction, natural hazards, pandemic outbreaks, power outages, or economic crises. Recent notable supply-chain failures include the 2021 Texas power crisis, personal protection equipment shortages during the COVID-19 pandemic, and regional or global food chain shortages. The consequences of such sh
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Reports on the topic "Pharmaceutical Manufacturing Risks"

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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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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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O'Donnell, Kevin, and Anne Greene. A Risk Management Solution Designed to Facilitate Risk-Based Qualification, Validation, and Change Control Activities within GMP and Pharmaceutical Regulatory Compliance Environments in the EU—Part II. Institute of Validation Technology, 2006. http://dx.doi.org/10.1080/21506590.wp7142006agko-rmsdii.

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highlight the need for patient-focused and value-adding qualification, validation, and change control programmes for manufacturing and regulating medicinal products in the EU, which are cost-effective and in-line with current regulatory requirements and guidance. To this end, a formal risk management solution was presented that seeks to demonstrate, in a practical way, how Regulators and Industry in the EU may achieve these goals. This solution represents a formal and rigorous approach to risk management, offering a scientific and practical means for determining and managing, on a risk basis,
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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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