Dissertations - Pharmaceutical Business & Technology
Permanent URI for this collection
Browse
Recent Submissions
Item Investigating the Effect of Segregation in the Manufacturing Of Solid Dosage Forms in Pharmaceutical Industries in Northern India(2024-01) Uday, HridyaTablets are the most often used solid oral dose form due to their high patient compliance, stability, simplicity of handling, and convenience of transportation. Tableting technology has come a long way over the years. Due to issues with segregation, content homogeneity, and physical stability, mixing and formulating solid dosage forms can be extremely difficult. When producing solid dosage drug products, these variables must be carefully controlled. A homogeneous and segregation-free dosage formulation must be developed, which requires careful consideration of the excipients used at each stage of the formulation and process development process. A wide range of equipment has been developed to make it easier to combine excipients with solid dose pharmaceuticals. There have been reports of several novel formulation procedures in addition to traditional methods including direct compression, wet granulation, and dry granulation. With the goal of establishing content homogeneity during the mixing and formulation of solid dosage medications, these technical innovations have enhanced the manufacture and quality of solid dose medicinal products. This study aims to thoroughly examine the segregation techniques currently used by pharmaceutical companies in Northern India, assessing how well they comply with industry best practices and regulatory standards. By addressing and taking into consideration the factors, challenges, and limitations in the business, the author of this study examined the degree of the concerns generated by segregation in the Indian pharmaceutical sector in the context of a thorough literature analysis. The author's expertise of this subject was enhanced by earlier publications, which helped her collect the primary data for her research study. Through an investigation of challenges encountered by manufacturers during the implementation of effective segregation methods, the study aims to offer pragmatic perspectives and suggest suggestions for enhancing production procedures. An online questionnaire survey consisting of fourteen questions was distributed to a group of pharmaceutical experts employed in various pharmaceutical organizations around Northern India in order to collect data for this study. This study highlights the various strategies incorporated in pharmaceutical manufacturing. With insights that can help with product quality, regulatory compliance, and eventually patient access to safe and effective pharmaceuticals, the expected results will have a major impact on the pharmaceutical sector in Northern India. At present, the Indian pharmaceutical industry is dedicated to enhancing its production processes through the use of measures aimed at reducing segregation. With time pharmaceutical industries have ventured to adapt innovative ideas for a better future ahead.Item Electronic batch records and the process of their design and implementation within a multi-product biopharmaceutical facility in Ireland(2024-01) O'Driscoll, JeanThe dissertation relates to electronic batch records and the process of their design and implementation within multi-product biopharmaceutical facilities. This dissertation outlines the position of electronic batch records (eBR) in the current age of digitisation within the biopharmaceutical industry. It presents the benefits that can be obtained through eBR implementation, particularly in the realm of compliance and right-first-time execution. It presents the quantity of paper record reduction within a single biopharmaceutical facility. It also outlines the challenges introduced with eBR implementation and the requirements for companies to adopt practices and processes to realise the associated benefits. This research was focused within a single company comprising of numerous biopharmaceutical facilities on one site located in Ireland. This dissertation identified the technical hurdles that must be overcome during eBR implementation, and also the organisational barriers that could impede successful implementation. Data was collected across organisational hierarchies via an online survey (N=119). This survey aimed to collect data as it relates to (i) internal attitudes towards eBRs, (ii) eBR familiarity, (iii) ease of eBR adoption, (iv) understanding of eBR processes, (v) understanding of eBRs compared to paper records and, (vi) time/experience impact on eBR attitudes. This data was analysed to identify relationships between organisational role/functional role and the areas of investigation. Qualitative data was also collected via a series of semi-structured interviews (N=11). These interviews were completed with subject matter experts (SMEs) in eBR implementation and participants were either presently or previously involved in an eBR implementation project. They were conducted across technical and management personnel who were identified as either (1) business SMEs, experts in paper batch record content and production processes or, (2) eBR SMEs, personnel familiar with IT requirements to enable the translation of paper process to electronic. The interviews aimed to gather information across the following areas, (i) role in eBR implementation (ii)understanding of drivers for eBR implementation(iii) priority of eBR implementation within the business, (iv) challenges and benefits associated with eBR implementation, (v) structure of eBR implementation, and, (vi) behavioural and technical challenges of eBR implementation. The output from the surveys and interviews was interpreted to establish research findings associated with this dissertation. The research found that the implementation of eBRs is a complex process, and its success is not depending on a single variable. Findings showed that both technical and organisational challenges exist, and improvements can be made by addressing both areas. The research revealed the compliance benefits obtained through eBR implementation. It also demonstrated the significant time saving and streamlining effect of eBR in the process of batch release. However, this research also showed a need for an internal mindset change to the eBR implementation approach. It indicated a requirement for processes and practices to evolve to enable both eBR implementation and maintenance into the future. This research demonstrated the importance of understanding gaps within the current process and potential risks associated with knowledge management and training in eBRs. This dissertation’s research findings present an opportunity to adapt current approaches to eBR implementation to enable the benefits of eBR implementation within the organisationItem A case study evaluating healthcare professionals’ generic prescribing practices in a single medical institution in Nigeria(2023-08) Mariam Akinlabi, WuraolaHealthcare systems worldwide are influenced by the practices and decisions of healthcare professionals, especially in relation to their prescription practices. This case study explores the prescribing practices of healthcare professionals withing a single medical institution in Nigeria. The study aims to assess the level to which generic prescribing practices are embraced, considering the effects on healthcare affordability, accessibility, and overall patient care. The increased healthcare expenditures, and patients access to essential treatments, has caused the adoption of generic medications as a strategy to reduce these challenges. Generic medicines are pharmacologically equivalent alternatives to branded medicines. This investigation takes place within the distinctive context of the healthcare scenario in Nigeria, including its economic diverseness, and evolving regulatory landscape. The scope of this study was confined to a singular medical institution, with diverse health professionals by diving into the prescribing practices, and further into the factors that may influence generic prescribing decisions. The research methodology that was appropriate for this research Is the quantitative research approach, and this research incorporated a survey method that utilized an online survey questionnaire to obtain information from participants. The estimated sample size for this survey was 100, with the main target of healthcare professionals being general/medical physician and pharmacists. The response rate obtained for the duration of data collection is 64%, with 53 being general/medical physicians, and 11 pharmacists across various departments in the University College Hospital Ibadan Nigeria. The findings from this study did not only contribute to the existing body of knowledge on prescription practices and patterns, but also offer insights to healthcare policy makers, administrators and practitioners to improve the current quality care given to patients, while also addressing the factors that influences their generic prescribing choices. The result of this study showed that majority of participants had knowledge on the therapeutic equivalence of generic medicines and branded medicines, and majority were also familiar with the factors that may be influencing their generic prescribing decisions.Item The applications of AI (Machine learning & RPA) Phase III Clinical trials in India(2023-08) Chaurasia, ShubhangiRapid developments in machine learning (ML) and robotic process automation (RPA), both aspects of Artificial intelligence (AI), have resulted in a major change in several sectors, including the pharmaceutical and healthcare industries. After receiving regulatory permission and being made available on the market, phase III clinical studies are essential for assessing the safety, effectiveness, and side effects of new drugs and medical treatments. To improve their efficiency and effectiveness, however, these experiments frequently need a lot of time and money and are at risk of human error. This research makes valuable contributions by filling the highlighted research gap through a thorough examination of the viability, challenges, and benefits associated with the implementation of artificial intelligence (AI), machine learning (ML), and robotic process automation (RPA) technologies in Phase III Clinical Trials. By conducting a comprehensive analysis of academic work, relevant approaches, and practical instances, this study highlights the inherent capabilities of these technologies in enhancing functional efficacy, data accuracy, and well-informed decision-making processes within the field of clinical trials. The integration of different aspects of the research is facilitated by the identification of a research gap and a thorough examination of the existing literature. The research aims aim to evaluate the suitability of artificial intelligence (AI), machine learning (ML), and robotic process automation (RPA) in Phase III Clinical Trials within the India. The research enquiries aim to explore and identify the difficulties that exist and viable solutions to address them. The research technique combines qualitative interviews with key stakeholders and quantitative analysis of historical trial data. The findings highlight the positive effects of combining AI, ML, and RPA, focusing improved patient enrolment, improved monitoring practices, and more trustworthy data analysis. The analysis of these data situates the outcomes within the distinct framework of clinical trials conducted in India, taking into consideration the regulatory, cultural, and technological complications that are relevant to the area. The main goal of this research is to provide detailed information on the implementation of artificial intelligence (AI), machine learning (ML), and robotic process automation (RPA) in Phase III Clinical Trials conducted in India. It offers practical suggestions for key stakeholders such as pharmaceutical companies, regulatory agencies, and researchers, empowering them to effectively adopt and leverage new technological breakthroughs. In conclusion, this study offers important new information about the possible influence of AI (ML & RPA) in Phase III clinical trials in India. Stakeholders in the pharmaceutical sector, researchers, and regulatory agencies can make well-informed judgments on the use of these technologies by considering the advantages and limitations of AI adoption. To ensure the successful incorporation of AI in the effort of increased clinical research quality in India, the study also highlights the significance of addressing ethical concerns and embracing technical breakthroughsItem The analysis and impact of adopting sustainable blister packaging on solid dosage form in pharmacies in Ireland(2023-08) Antony, ReshmaThe pharmaceutical industry's commitment to sustainable practices has prompted a paradigm shift in packaging solutions, with a specific focus on sustainable blister packaging. This dissertation scrutinizes the multifaceted landscape of sustainable blister packaging practices within the context of pharmacies in Ireland, aligning its findings with the predefined objectives. The central objectives of this study encompass the exploration of pharmacists' familiarity with sustainable blister packaging, the identification of challenges hindering its adoption, the assessment of perceived benefits, and the formulation of recommendations to enhance sustainable packaging practices. By leveraging a combination of quantitative and qualitative methodologies, this study offers a comprehensive analysis of the subject matter. The research commences by profiling the demographics of surveyed pharmacists, unveiling their experience levels and familiarity with sustainable blister packaging. These insights inform the understanding of the pharmacist's perspective within the broader context of sustainable packaging practices. Furthermore, the study explores into the challenges encountered during the adoption of sustainable blister packaging, highlighting storage constraints, regulatory guidelines, cost considerations, and availability of suitable options. The analysis of these challenges contributes to the formulation of targeted strategies to overcome barriers to sustainable practices. A fundamental aspect of this dissertation lies in the assessment of perceived benefits associated with the adoption of sustainable blister packaging. The research underscores a notable consensus on the environmental advantages, reduction of plastic waste, and improved sustainability brought forth by sustainable packaging. These findings underscore the alignment between participants' perspectives and the overarching goals of sustainable packaging initiatives. Aligning with the defined objectives, the study culminates by offering recommendations and best practices to foster the adoption of sustainable blister packaging within pharmacies. These recommendations encompass the need for widespread awareness campaigns, education initiatives, and training programs to facilitate informed decision-making and responsible choices. By addressing each objective, this study provides a comprehensive framework for enhancing sustainable packaging practices in the pharmacy sector. In conclusion, this dissertation sheds light on the intricate dynamics of sustainable blister packaging practices within Irish pharmacies. Through an insightful analysis of findings, the study contributes valuable insights on sustainable packaging, offering practical implications for the industry's shift towards more environmentally responsible practices.