MSc in Pharmaceutical Business and Technology

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A Study of The Key Challenges in the Nigerian Pharmaceutical Industry, With Emphasis on the Regulation and Quality of Medical Devices
(Innopharma, 2023) Osidele, Mosopefoluwa; Vasquez-Robinet, Cecilia
The Nigerian pharmaceutical manufacturing sector holds significant importance for Nigeria's economy, particularly in relation to medical devices. Extensive research conducted on the Nigerian medical device industry has highlighted numerous challenges that hinder the sector's development. This study aims to investigate the challenges faced by the Nigerian pharmaceutical industry, with emphasis on the regulation and quality aspects of medical devices. Usar et al. (2017, p. 86-91). emphasize the weak state of pharmaceutical regulation in Nigeria, characterized by irregular inspections, inadequate enforcement, widespread violations, and resultant negative health outcomes. To structure the research process, the study adopts the Research Onion framework proposed by Saunders, Lewis, and Thornhill in 2009. The interpretivist research philosophy plays a central role in this dissertation's context. Employing a deductive research approach, the study aims to collect data and formulate a theory based on the obtained results Saunders et al. (2019, p. 207). A case study strategy is employed to gain in-depth understanding of the challenges, particularly in the regulatory and quality aspects, faced by the two selected medical device manufacturing firms and the regulatory authorities that restrict their performance. The research design involves a mono-method approach for data collection. The gathered data is then analyzed thematically, contributing to the overall research findings. The study reveals significant weaknesses in the current regulatory framework for medical devices, including poor implementation of guidelines, lengthy processing times, and inadequate post-marketing surveillance. Regarding challenges related to the manufacturing of high-quality medical devices, the study identifies the lack of raw materials and the unavailability of custom-made machine parts as key factors affecting the production capabilities of medical device manufacturing firms in Nigeria. Insufficient funding, policy inconsistencies, regulatory duplication, and high inspection costs are identified as factors contributing to the ineffectiveness of medical device regulation and registration. Finally, in terms of the efficacy of quality and safety management practices, the study concludes that the existing practices are inadequate in ensuring the utmost safety of the public.ts.
Evaluating the Impact, reaction, and building of resiliency among public and professionals caused by the disturbed Pharmaceutical Supply Chain due to the Russia-Ukraine War
(Innopharma, 2023) Mukunda Wankhade, Vishake; Alvarez, Yolanda
The focus of this research is to look into the influence of the Russia-Ukraine conflict on the Pharmaceutical Supply Chain as seen by the general public and supply chain specialists. The study also investigates the public's reaction and the development of resiliency among professionals, industry, and institutions. The major factors that affected the supply chain, particularly in the pharmaceutical business, such as Covid-19 and Brexit, are explained first. Following that, the primary crisis caused by the Russia-Ukraine war and its consequences are examined. The literature review indicates the impact of the conflict on policies, product manufacturing (particularly pharmaceuticals and medical devices), and clinical trials. Furthermore, the study looks at how different governments and businesses manage their supply networks and other departments during catastrophes. It highlights the individual nature of each crisis and the varying responses by different countries by highlighting examples from Covid-19 and the Russia-Ukraine war. Surveys and questionnaires were used to collect information from the general public and specialists on product shortages during the war, with a focus on their business continuity plans in different crises scenarios. The study concludes by outlining the categories of items that experienced shortages and highlighting the efforts taken by professionals at both the personal and corporate levels to mitigate supply chain interruptions. Using a realistic perspective, this study presents an examination of reality as experienced by all survey and interview participants.
Challenges in the Adoption of Biosimilars in India
(Innopharma, 2023) Jayachandran , Jayalakshmi Punchaparamban; Cheidozi, Chiamaka
The main aim of this research was to identify the main challenges faced by the pharmaceutical companies of India for the adoption of biosimilar drugs in the most recent scenario. Although there are several factors affecting the wide development and usage of biosimilars, in this study it was found that the lack of consumer or patient awareness followed by concerns on the safety and efficacy of biosimilars and lastly the lack of physician education and the inadequate regulatory framework for their development and approval. It was also noted that most of the study participants believe that India has a promising future for biosimilar drugs and the market is attractive for investment. The primary methodology of the study was quantitative survey which was carried out among 158 random pharmaceutical professionals of India to get their insights on the factors hindering on biosimilars. In addition, market analysis was carried out to provide comprehensive understanding of biosimilar landscape in India and a case study on a safety incident of biosimilar product approved in India showed how a more streamlined regulatory network could help in raising the quality of biosimilar drugs to other international standards. The multiple linear regression was carried out on the collected survey data and the findings showed there is no significant relationship between the experience of pharmaceutical professionals to the knowledge on biosimilar products and to the willingness to adopt a biosimilar product. Inorder to overcome the barriers, public education initiatives, trainings for healthcare professionals and conducting thorough pharmaceutical surveillance for analyzing the safety and efficacy of biosimilars can be carried out. Overall, by identifying and examining the key challenges, this research adds to the ongoing discussions about the adoption of biosimilars in India. The outcomes can guide future policy choices and strategic actions aimed at encouraging the widespread use of biosimilars, which will ultimately result in improved access to reasonably priced and high-quality biologic therapies in India.
Attitude and Challenges of Consumers and Pharmacists Towards Reporting Counterfeit Medicines in Lagos State, Nigeria
(Innopharma, 2023) Sinclair Chibuzor, Hillary; Chiedozie, Chiamaka
Counterfeit medicines are drugs deliberately misbranded, mislabeled, or adulterated with the intention of deceiving people into thinking they are genuine. Consumers and pharmacists play vital roles in reducing their circulation by reporting suspicious products to the authorities. Such information provides the regulatory authorities with valuable insights, enabling them to take necessary actions to stop the distribution and sale of these drugs. This study aimed to evaluate the knowledge of consumers and pharmacists in Lagos regarding the presence of counterfeit drugs in the Nigerian market, their associated risks, and their attitudes toward reporting such drugs. Additionally, the study investigated the challenges these groups faced when reporting such drugs and provided recommendations for overcoming these obstacles. The study collected primary data through an online questionnaire survey and phone interviews. The survey received responses from 182 consumers and 126 pharmacists, while the phone interviews were conducted with 8 highly experienced pharmacists to obtain their personal perspectives on the subject matter. Analysis of the collected data revealed that consumers and pharmacists in Lagos exhibited a high level of awareness about the presence of counterfeit medicines in Nigeria and the health risks associated with them. However, both groups demonstrated reluctance to report such medicines. The study revealed that the two groups faced similar challenges when reporting counterfeit medicines, with the most common problems, as noted by the majority of respondents in each group being a lack of knowledge on how to report (70.9% consumers, 51.6% pharmacists), difficulty in identifying counterfeit medicines (69.8% consumers, 64.3% pharmacists), and lack of confidence in the regulatory authority’s effort in combating the issue (69.8% consumers, 54.8% pharmacists). ress these challenges, the study proposed providing education and awareness programs to teach people how to identify and report counterfeit medicines, as well as providing feedback to individuals regarding the status of their reports and investigations. The researcher recommended that NAFDAC prioritize addressing the challenges which were identified by the largest number of participants in both groups to improve the reporting of counterfeit medicines in Lagos.
Assessing the Impact of Anti-Falsification Technology on Patient Choice of Prescription Medicines in Four Teaching Hospitals in Nigeria
(Innopharma, 2023) Yagazie Okechukwu, Anonye; Chiedozie, Chiamaka
Background: Falsified medicines over the years have had a major impact on both patients, manufacturing companies and national health budgets/insurance thus causing both economic and humanistic losses to stakeholders. It has caused an estimated loss of over 500 billion naira (625 million euros) to both local and foreign investors in the Nigerian pharmaceutical industry. This review analyzes data that was gathered between February 2023 to April 2023, through questionnaires designed to assessthe attitude of patients who were filling prescriptions with the background knowledge of falsified medicine detection. Aim: This study’s author theorized that authenticating labels and technology could affect the way patients see medicines and fill prescriptions. Methods: The study participants of 115 comprised of physicians 10%, pharmacist 47%, registered nurses 19%, medical laboratory scientists 15%, radiographer 2%, optometrists 3% and dentists 2% practicing across four teaching hospitals in Nigeria who participated through surveys. Data analysis was done using Microsoft Excel to produce charts, graphs and tables. Results: The analyzed data shows patients who have little or no awareness and those who gained awareness from their pharmacist or prescriber of medicine anti-falsification technology are likely to request for their prescriptions in its original packaging at a similar frequency. Whereas the data tilts and shows that those with little awareness are two-times less likely to suspect that a medicine is falsified when their treatment therapy fails and would often request for a change of brand or inform their prescriber as compared to the aware group who would immediately confirm suspicions that the medicine is “fake”. However, both groups would request for a known brand or generic whenever the prescription medicine lacks features for verification rather than seek reassurance of quality from their prescriber or pharmacist. Some of the recommendations provided by respondents to stop the spread of falsified medicines is the purposeful reeducation of the public on the dangers of falsified medicines and ways to detect them using technology and report them as a way of cleaning up the supply chain. The study participants recorded an 85.2% willingness to report identified falsified medicines to the regulators and may opt for a stepwise approach through their healthcare providers or hospital authority or a more direct approach to the national authorities. This is also a notable indication of the public resisting falsified medicines spread in their various capacities. The participants also confirmed an 6.1% willingness to use mobile authentication service technology and other features to verify if their medicines are original, but a higher 20.2% of respondents would always prefer to use the NAFDAC registration number alone or in combination, while a 10.5% would depend on the presence of other verification features like insignias and seals. Conclusion: The study demonstrates that there is a good awareness of anti-falsification technology and that knowledge affects how patients interact with their prescription medicines and causes a bias for known brands/generics while blaming therapy failures on suspected falsified medicines.
Application of process improvement tools and methodologies in supply chain logistic management in pharmaceutical industry
(Innopharma, 2023) Anaston, Snowitta; Derb, Munira
To improve a process, tools and techniques are used to identify and analyze problems and implement changes so that it is more efficient and effective. From data collection to problemsolving to monitoring and evaluation, they can be used at any stage of the improvement process. It is crucial to identify inefficiencies, bottlenecks, and quality issues in pharmaceutical supply chain logistics management with process improvement tools as they help organizations reduce waste, increase productivity, and enhance the quality of their products and services. Using these tools, organizations are able to analyze and improve their supply chain processes, resulting in an increase in efficiency, a decrease in lead times, and an improvement in inventory control. It is possible for pharmaceutical companies to improve customer satisfaction, reduce waste, and improve product quality by making use of these tools. A limitation in the research on pharmaceutical supply chain logistics management processes is the lack of understanding about the effectiveness and applicability of these tools in different settings and contexts. Furthermore, empirical evidence on the impact of process improvement tools on performance outcomes such as cost, quality, and customer satisfaction is lacking. This study aims to evaluate whether Lean and Six Sigma are the best process improvement tools for all logistics management or whether there are specific tools for improving specific logistics processes. There were 58 participants in the logistics industry, who were logistic managers, the logistic coordinators, and the logistics engineers, who were surveyed using Microsoft forms with a deductive approach. In supply chain logistics management, Lean and Six Sigma are popular tools for improving workplace productivity and reducing waste. As a result of implementing these tools, reverse logistics, compliance delays, and fines have been significantly improved. More than half of respondents agreed to using thirdparty logistics as a method of process improvement, including reverse logistics. Adapting to emerging trends can be enhanced by outsourcing supply chain logistics internationally. Future researchers will be able to use this study to determine what will be the most efficient and costeffective tools to use to improve your processes.
Lean Validation in the Pharmaceutical Industry in Ireland
(Innopharma, 2023) Scully, Laura; McLaughlin, Brendan
In this study, it was shown that implementing Continuous Improvement (CI) initiatives has been done within Pharmaceutical Validation in Ireland, to some extent. ‘Lean Validation’ is a concept that involvesthe implementation of CI initiatives into the process of Validation. Within the Pharmaceutical Industry, there is an enduring interest for an organisation to reduce waste and improve the efficiency of a process. Validation is a core pillar of the Pharmaceutical industry and the process can often be long, tedious and inefficient. This ideology behind ‘Lean Validation’ is to use tools from principles such as Lean and Six Sigma to reduce waste and improve the Validation process. The objectives of this research were to explore the extent to which organisations are currently implementing ‘Lean Validation’ principles, what the current challenges with implementing them are, and what specific areas and tools could be the most beneficial to focus these initiatives on within the Validation process. This research was conducted using a mixed-method approach, consisting of a survey and interview. The analysis of the data showed that CI tools and initiatives have been implemented within the Validation process, with the main goal of this to improve the efficiency of the process and to remove any aspect of the process that does not add value and can be considered ‘waste’ under Lean methodologies. The data showed there is some level of reluctance to implement CI within Validation, with the main challenges being lack of time and resources, and lack of engagement from personnel due to a ‘fear of change’. The study concludes that CI initiatives can be beneficial for the Validation process in a number of areas and provides suggestions for Pharmaceutical organisations looking to implement them and recommendations for further study.
The Impact of Working Irregular Hours on Quality and Human Resources in the Irish Pharmaceutical Industry
(Innopharma, 2023) Lucas, Charlotte; Coghlan, Susanna
INTRODUCTION. Ireland is a hub for pharmaceutical manufacturing activity. Due to business demands and/or nature of products being manufactured some pharmaceutical manufacturers have no other option but to manufacture 24/7. This research aimed to investigate the potential impacts of working irregular hours on human resources and quality in the Irish pharmaceutical industry. This research is important as it investigated factors influencing a pharmaceutical organisation’s operational excellence and quality management systems. OBJECTIVES. This research consisted of two primary objectives. The first was to determine if working irregular hours has any effect in the area of human resources (namely staff morale and staff turnover intention) by surveying both employees that work regular hours and those that work irregular hours in the pharmaceutical industry. The second was to determine if working irregular hours has any effect in the area of quality (namely quality assurance (QA) and right first time (RFT) manufacturing) by interviewing key subject matter experts working in the pharmaceutical industry. METHODS. To address the objective focusing on human resources quantitative research was used in the form of surveys. 84 people were surveyed: 44 shift workers (SWs) and 40 non-shift workers (NSWs). Questions were focused on areas of staff morale and turnover intention. Raw data from survey respondents were analysed using Chi Square Tests of Independence to determine whether difference between group were independent of each other. The objective regarding quality within manufacturing was addressed through using qualitative research in the form of interviews. SMEs were interviewed with questions focusing on QA and RFT manufacturing. Thematic analysis was carried out on interviews which involved open coding followed by axial coding. RESULTS. There was no significant difference between the groups for self-perceived levels of staff morale. There were however significant differences between groups when it came to other negative impacts associated with shift work. SWs were more likely to feel fatigued both during and after work, feel that their work negatively impacts their personal well-being, frequently feel under pressure in their role and feel emotionally agitated upon arriving home from work. It is possible that these negative implications of shift work may gradually impact employee morale over time by wearing people down. There were no significant differences between the groups and turnover intention. SWs were significantly more likely to admit that benefits associated with their job (i.e., compressed work week and financial bonus allowance) prevented them from quitting. An overall pattern was highlighted among the two groups that the rate of turnover intention increased over time. The majority of interviewees believed that irregular working hours had no impact on QA. Interviewees emphasised that quality errors can occur at any time of day and stated that there are many possible factors at play when looking at quality errors with human root causes rather than fatigue alone. These can include but aren’t limited to; operator competency, complacency, mindfulness for task at hand and diligence to work. Similarly, the majority of interviewees believed that working shift work had no impact on the rate of RFT manufacturing. The general consensus of interviewees was that systems should be in place in order to catch mistakes before they occur and therefore set operators up for success. CONCLUSION. Maintaining positive staff morale, low staff turnover, QA and RFT manufacturing are all important factors in ensuring operational excellence, productivity and products are produced to meet regulatory quality standards. This is why investigating potential factors which may impact these is important. Although some findings for this research thesis were insignificant, it helped highlight potential research areas for the future. These may include the impact of shift work on productivity or employee absenteeism all of which effect business functions. Looking closer at costs involved in investigating quality deviations would also be a worthwhile research topic.
An Evaluation Of The Use Of 3D Technologies In Developing Patient Specific Medical Devices For Interventional Radiology, And Its Potential Use For Producing A Personalised Embolic Coil for Peripheral Vasculature Embolization.
(Innopharma, 2023) O'Donovan, Joseph
In this study it was shown that patient specific embolic coils for peripheral intervention can be produced utilising 3D patient scans and current materials and industry standard processes. The use of patient specific medical devices is growing since the invention of 3D technologies. This study investigated using this same technology to design a patient specific embolic coil. A key objective of the research was to establish if a patient specific coil could address complications and issues that are encountered with Off The Shelf (OTS) embolic coils. Literature on patient specific medical devices, 3D imaging, and embolization were reviewed to map the current landscape of embolic coiling, patient specific medical devices, costs, and regulatory considerations. There was a gap in the literature regarding patient specific embolic coils. Primary Research was conducted via individual interviews with 13 subject matter experts (SMEs) from the fields of Interventional Radiology, Research & Development, Marketing, 3D Design and Process Development Engineering. The research found that there was no barrier to rendering a 3D anatomical scan into a patient specific embolic coil. Opinion of the SMEs was that current materials and standard manufacturing processes can be used to fabricate the same. The necessity for secondary devices, such as stents, can be overcome by producing a coil tailored to the patient’s anatomy. Prolonged procedure time can be reduced by delivering coils with a patient specific length. A wide range of OTS coils and liquid embolics exist, which provide the Interventional radiologist with a level of customization for each patient. It was found that a patient specific coil could be produced but that there may be only niche use for peripheral vascular treatment. The emergent nature of peripheral embolization procedures was deemed incompatible with the planning, design and manufacture required to produce a patient specific device. It was recommended the study be carried out in the field of Neuro Interventional Radiology as the level of planning, risk-reward and the specificity of tools required were greater than in Peripheral Vascular field. Also, it was recommended that research be conducted into the development of resorbable coils for Musculoskeletal (MSK) conditions
Item Evaluation of the impact of Quality management and Regulatory systems in the manufacturing processes of Albendazole in The Republic of Paraguay and The Republic of Ireland
(innopharma, 2023) Lujan Ferreira Ayala, Maria; Clarke, Kathy
The present dissertation aims to evaluate the impact of Quality management and Regulatory systems on the Albendazole manufacturing processes in the Republics of Paraguay and Ireland.The legal framework and quality managerial procedures of the business as well as its in both countries will be evaluated. When examining the impact of a company's quality system on its products, the opinion of pharmacists and other industry sectors regarding overseas and Paraguayan pharmaceutical industries products would also be considered. This objective would be accomplished through a quantitative questionnaire survey. The results of the survey with 54 participants, including pharmacists, quality officers, and other positions, and a literature review of the regulatory systems and quality management procedures of the pharmaceutical industry revealed that the regulatory framework in Paraguay needs to adjust in order to be able to manufacture Albendazole for exporting to Ireland and that the entire pharmaceutical industry has gaps that need no te adjust the European union quality system. Inaddition, the research was able to recognize the variables that influence the quality and availability of Albendazole products manufactured in Paraguay that comply with Ireland pharmaceutical industries, such as regulations/guidelines for manufacturing of high-quality medicinal products, demand exceeding supply, and high prices for high-quality Albendazole products. The study recommends that DINAVISA make the Paraguayan Pharmaceutical sector'sactivities more transparent and that additional resources be made available to Paraguayan pharmaceutical industries in order for them to comply with European Union regulations in order to manufacture Albendazole with the same quality
A Study on The Extent to Which Block Chain Technology Prevents Counterfeit Medicine Distribution in the Indian Pharmaceutical Industry
(Innopharma, 2023) Susanna Alex, Anju; McLaughlin, Brendan
When it comes to producing generic drugs, India dominates the market. More than half of all vaccines produced, as well as 40% of all generic drugs sold in the United States, come from India's pharmaceutical industry. By volume, India is the third-largest pharmaceutical producer worldwide, and by value, it is the fourteenth-largest. A counterfeit medicine or counterfeit medication is a drug or pharmaceutical product that has been produced and distributed with the goal to misrepresent its origin, validity, or effectiveness. Blockchain is the future of technology because of its distributed database structure and the unparalleled data security and integrity it provides to its users. Many industries, including the pharmaceutical, will benefit from blockchain technology's ability to speed up their digital transition. In this study, I intend to investigate the problem of counterfeit drugs in India, as well as their effects and potential technological solutions. The study will provide light on how blockchain technology can be used to stop the spread of counterfeit drugs, which, as is widely known, can have devastating effects on human health. In addition, this research looks at the difficulties of putting blockchain systems into practise. Quantitative and qualitative methods are used interchangeably in this investigation. The quantitative approach often involves an inquiry by use of a survey questionnaire. In order to get the necessary information, a questionnaire would be developed and sent electronically to workers at pharmaceutical firms in India. Interviews with a supply chain and production management from a well-known Indian firm are done for qualitative research. Both sets of data are combined to reach the ultimate conclusion. By using blockchain technologies in the Indian pharmaceutical sectors the distribution of counterfeit medicationsare prevented to about 20%-40%. From the interviews it was found that blockchain technologies are associated with many challenges. When all these challenges are tackle down blockchain can work with more efficiency and thereby we can completely avoid the counterfeit medicines distribution and issues related to it like health issues, mortality rate and so on. Fromthe study conducted it was found that Indian pharmaceutical firms were among the few in theworld to employ innovative technologies like blockchain to stop the distribution of fake drugs in the Indian pharmaceutical industry. Pharmaceutical companies employ blockchain echnology to create a distinct digital identity for each product at the time of manufacturing.The product's digital identity is validated and recorded on the blockchain at every step of thesupply chain. This ensures that the item is real and unaltered. This is how the blockchain technology utilized by the Indian pharmaceutical sector prevents the distribution of fake pharmaceuticals.
Comparative Analysis of Lean Six Sigma (LSS) and AI Integration to optimise production speed and quality of pharmaceutical products in Ireland
(Innopharma, 2025) Karnayana Basappa, Jeevan
This exploration explores Lean Six Sigma (LSS) and Artificial Intelligence (AI) affected production quality and speed in Irish pharmaceutical industry. Findings provide clear shift to digital transformation as AI implementation reached 38% and combined LSS with AI reached 34%. It represents a decreasing reliance on traditional methods by comparison only 16 % of companies rely on LSS. Analysis examines divided perceptions of effectiveness as some participants reported strong advantages while others viewed aspects as ineffective. ANOVA analysis confirmed that employee roles effectively affected viewpoints of AI site type and speed influence effectively affected LSS quality advantages. These outcomes provide that success rely on training and context management instead of resources or rganisational size. For consistent quality improvement, LSS was built to be an organised framework while AI given dynamic forecast power that plays a sensitive role. Application emerged as most significant approach as it merged systematic process control with advanced analytics. Recommendations emphasise contextual deployment, tailored and leadership alignment training to indicate challenges like skill shortages, cultural resistance and high costs. Further priorities involve supporting integrated strategies and investing in infrastructure that align with LSS and AI for sustainable enhancement. The research mainly focuses on achieving evidence confirming that impact of LSS is context dependent AI drives digital transformation and their implementation proves most powerful results. Limitations involve reliance on uneven role representation, cross sectional analysis and self-reported data that restricts causal insight and generalisability. Future research must implement longitudinal designs that spread through applied advanced modelling and global comparisons techniques to examine deeper relationships. Regulatory and ethical dimensions of AI implementation also merit exploration to enhance industry practice and academic understanding.
Exploring the Application of AI/ML Systems in Fostering Regulatory Compliance and Audit in Oncology Trials
(Innopharma, 2025) Vuyyuru, Gayathri; Chiedozie, Chiamaka
This study investigates the integration of artificial intelligence (AI) and machine learning (ML) systems in regulatory compliance and audit processes within oncology clinical trials. Through a quantitative survey of 102 clinical research professionals, the research evaluates current adoption patterns, effectiveness, and challenges of AI/ML implementation in compliance monitoring. The findings reveal that while 47.1% of organizations currently use AI/ML tools for compliance, adoption remains fragmented and transitional. Natural Language Processing (19.6%) emerged as the most commonly used technology, primarily for documentation management. AI/ML systems demonstrated moderate effectiveness in detecting protocol deviations (28.4% rating them moderately effective) and reducing data discrepancies (46.1% reporting improvements). Risk assessment (28.4%) and compliance monitoring (28.4%) were identified as the most improved aspects following AI/ML adoption. However, significant barriers persist. Key challenges include data privacy concerns (23.5%), lack of regulatory clarity (21.6%), and technical complexity (20.6%). Only 41.2% of respondents believed their AI/ML tools were adequately validated for regulatory compliance, while 25.5% perceived these systems as lacking transparency. The study revealed role-based differences in perceptions, with technical professionals expressing greater confidence in AI/ML systems compared to regulatory and quality assurance staff. Despite demonstrable benefits in error reduction (63.7% reported decreased human error) and audit efficiency, only 32.4% of respondents recommended wider adoption. This cautious stance reflects ongoing concerns about validation standards, explainability, and regulatory acceptance. The research concludes that while AI/ML offers significant potential for enhancing oncology trial compliance, successful integration requires clearer regulatory frameworks, improved system transparency, and cross-functional alignment between technical and compliance teams. These findings provide crucial insights for organizations navigating the complex landscape of AI/ML adoption in regulated clinical research environments.
Evaluating the Role of ICH Q9-Based Quality Risk Management in Reducing CAPA Recurrence Rates: A Study of GMP-Regulated Pharmaceutical Companies in Ireland
(Innopharma, 2025) Cladissophiya , George; Vendrell, Dr. Victor David
This research examines the contribution that Quality Risk Management (QRM) under the ICH Q9 framework can make to resolving the long-standing problem of recurring Corrective and Preventive Actions (CAPAs) in Irish pharmaceutical manufacturing. Even with good regulatory management that is seen with EU GMP, the repeated occurrence of problems within many sites remains to be a source of disappointment to product quality and efficiency within the operations. This research study conducted a systematic survey of 109 quality professionals to investigate the maturity of QRM practices in use, perceived utility of QRM tools, and the degree to which regulatory alignment can be used to impact the results of CAPAs. The results point out that greater QRM maturity is strongly linked to increased CAPA success and lower recurrence. The respondents in the locations that have high integration of QRM practices gave higher ratings to the effectiveness of CAPA processes and those with low levels documented recurring issues. The regression analysis also showed that the alignment of regulatory practices to the EU GMP and ICH Q9 regulations significantly affected the decline of CAPA recurrence, but the actual presence of formal QRM policies did not cause significant difference. The work has academic and practical contributions by highlighting the importance of a better integration of QRM into CAPA investigations, as opposed to policy-based adoption. Practitioner recommendations to the industry, as well as academic recommendations on the longitudinal effects, are given.
Cross-Cultural Perceptions of Clinical Trials Among Young Adults (20-35) in Mumbai and Dublin: A Comparative Study of Awareness and Participation Willingness
(Innopharma, 2025) Rajaram Vishe, Ketki; Russell, Elizabeth
This dissertation looks at how young adults (aged 20–35) in Mumbai and Dublin think about clinical trials. The aim was to compare their awareness, willingness to participate, and the barriers they face. To achieve this aim, the research followed a mixed-methods design. A total of 120 participants (60 from Mumbai and 60 from Dublin, with equal representation from healthcare and non-healthcare backgrounds) completed an online survey. In addition, qualitative insights were gathered through open-ended responses from 10 participants to capture deeper reflections on trust, safety concerns, and cultural influences. This approach provided both a broad overview of patterns and richer, context-specific perspectives. The findings revealed that while general awareness of clinical trials was high in both cities (83.3% of respondents had heard of them), detailed understanding of processes, ethical oversight, and participant rights remained moderate. Trust and safety emerged as the most decisive factors in shaping willingness to participate. Fear of side effects (reported by 75% of respondents) and concerns about being “treated like a test subject” were key barriers, while family influence also played a role in both cultural settings. Interestingly, the comparison showed that young adults in Mumbai and Dublin shared more similarities than differences: both groups displayed cautious willingness, similar reliance on healthcare professionals for information, and skepticism towards social media advertisements. The most striking difference was that healthcare-educated participants in both cities consistently showed higher levels of understanding, trust, and willingness to participate than their non-healthcare counterparts, highlighting the importance of education over cultural background. The study concludes that while culture influences perceptions to some extent, globalization, digital access, and shared concerns about safety and trust have created strong cross-cultural similarities. The findings suggest that improving youth participation in clinical trials requires transparent communication, trust-building initiatives, and targeted education rather than relying solely on cultural tailoring. Practical recommendations include using healthcare professionals as primary communicators, integrating clinical trial literacy into educational programs, and leveraging digital platforms for awareness while avoiding over-reliance on advertising. This research contributes to the growing body of literature by filling a gap in understanding young, healthy adults’ views in a cross-cultural context. It emphasizes that education and trust are more critical than nationality in determining willingness to engage in clinical trials. For industry and regulators, these insights provide valuable guidance on designing recruitment strategies that are both ethical and effective. For me as a student, the dissertation was a meaningful learning process, as it connected pharmaceutical business and technology with real-world challenges of clinical research engagement.
Investigation of Periodic Review Validation Practices on Small Scale and Vendor Process Equipment in Pharmaceutical Manufacturing in Ireland
(Innopharma, 2025) Devlin, Stephen; McMahon, Gillian
Integration of infrastructure and interconnection of computerised systems in pharmaceutical manufacturing in Ireland is ever-increasing. Organisations are collating data from multiple GxP (Good Practice) systems to generate large datasets from computerised systems. This collation of data is to support the drive for increased contextualisation of the entire manufacturing process for the purpose of delivering increased efficiencies and exploring new methods of production. Despite these advances, and to satisfy current regulatory requirements manual review of systems events continue to be the norm, formerly isolated systems critical to the development of pharmaceutical product can interface to archives and historians but the event logs and audit trails, crucial in maintaining compliance and quality are largely required to be manually investigated by trained personnel. This research was undertaken to investigate current practices of this type of review and capture the awareness of professionals tasked with supporting, executing or reviewing these tasks. The research also explores modern solutions, attitudes and concerns to using advanced technologies such as validated scripting tools and AI models to understand how academic research, industry practices and professionals tasked with supporting these logs for regulatory purposes feel about their use. The research also proposes a framework for the implementation of different methods of review to increase the efficiency, consistency and effectiveness of the task, to assign potential owners and distribute actions.
Optimisation of Blend Uniformity in a Low Dose Dry Powder Inhaler Formulation: Investigating API and Excipient Interactions and Process Parameters
(Innopharma, 2025) Grant, Michelle; McHugh, Catherine
This dissertation investigates the optimisation of blend uniformity in low dose dry powder inhaler (DPI) formulations, focusing on the interplay between active pharmaceutical ingredient (API) and excipient interactions, as well as critical process parameters such as blending time and speed. Through a combination of literature review, experimental analysis, and scale up studies, the research explores how material properties and mechanical energy inputs influence blend performance. Findings revealed that while process optimisation reduced variability (%RSD) and improved uniformity in several batches, three out of eight failed to meet acceptance criteria, and most exhibited high maximum API content values. Particle size distribution (PSD) and scanning electron microscopy (SEM) analysis confirmed that excipient morphology played a key role in API adhesion and dispersion, with coarse lactose enhancing flow and fine lactose improving binding. Successful scale up from low shear to high shear blending using matched tip speeds demonstrated reproducibility and robustness, validating the hypothesis that mechanical energy translation supports consistent blend quality. However, limitations such as manual sampling bias, narrow material scope, and lack of real-time analytical tools were acknowledged. This study contributes a scalable framework for DPI blend optimisation, emphasising the need for integrated formulation and process development. It advocates for a flexible, science-driven approach to manufacturing that enhances product quality and supports commercial feasibility.
Assessing the Regulatory Role of GMP audits for APIs
(Innopharma, 2023) verma, Aayushi; Vecchi, Dr. Alessandra
The pharmaceutical sector is crucial to global economics as well as the preservation and advancement of human wellness. For people to live healthier and longer lives, the industry closes the gap among their health and lifespan. Good manufacturing practices audits have been implemented to direct the behaviour and operations of Active Pharmaceutical Ingredients to protect the public's health and safety from phony, illegal, or tampered APIs. This research study has attempted to analyse the restrictions for APIs that have emerged inside the GMP sector in the pharmaceutical business. After conducting a literature search, the research's objectives were informed by the shortcomings in the field. These gaps include the significance of GMP audits for APIs, challenges, and implications in ensuring API quality, the extent to which regulatory authorities mitigate these issues, and the creation of a framework for the role of various regulatory authorities in standardizing GMP audits for APIs. Six participants were chosen for the analysis using the convenience sample approach, which is a type of exploratory design used in qualitative research. Zoom was used to start semi-structured interviews with the participants to get their qualitative information. The gathered qualitative responses were analysed using the Gioia qualitative data evaluation method. The study concluded with 1. the goal of GMP audits is to make sure that a facility is producing pharmaceuticals with efficacy, compliance, and continuous improvement. 2. Audits and manufacturers are facing challenges with complex supply chain, regulatory complexity, and counterfeiting. 3. The biggest implication of noncompliant APIs is patient safety. 4. Participants made recommendations as continuous improvement, corrective actions, and revalidation. Results demonstrate that the regulatory role of GMP audits for API in the pharmaceutical industry has enhanced the sector, yet there still exists a need for advancement and further growth if the sector is to compete with its counterparts in other regions of the developed world, particularly in the context of higher utilization of technology and enforcing of the legal regulations governing the sector. Academia scholars, authorities, pharmaceutical products, producers, buyers, and government agencies will all profit from the present research's input.

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