This repository is a collection of research and scholarly output from Innopharma.
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Item Investigating the Effect of Segregation in the Manufacturing Of Solid Dosage Forms in Pharmaceutical Industries in Northern India(2024-01)Tablets 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)The 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 Reviewing The Potential Application of Bovine Dairy Powders in Supporting Healthy Aging of Humans(2023-12)By 2050, twenty-two percent of the world’s population will be over the age of 60. Of this cohort, 80% will reside in developing regions. The focus of this thesis is to review the potential application of bovine dairy powders in supporting healthy aging of humans. Due to the economic status of this cohort require an affordable product with a prolonged shelf life is required. The evaluation of dairy and its role supporting a healthy aging population was assessed through evaluation of peer reviewed scientific papers and studies. Healthy aging allows enables the wellbeing in an individual both physically and mentally to carry out daily functions free from disease and disability. Osteoporosis, sarcopenia and cognitive decline were the three most prevalent diseases associated with aging and are considered global health concerns. With the aging demographic increasing, these 3 diseases were the focus of this study. Bovine milk powders are the most affordable source of dairy nutrients and also have the longest shelf life. Through investigation it was found that a lack of bone density was the cause of osteoporosis, muscle weakness was the cause of sarcopenia and oxidative stress was a key factor in cognitive decline. Calcium and vitamin D combined in fermented dairy was shown to increase bone density. Whey protein was shown to increase muscle mass. Whey peptides and amino acids were found to reduce oxidative stress. The key nutrients required to mitigate all 3 disease was found in a whey protein isolate powder and fortified in line with the recommended daily intake of an elderly person and a manufacturing cost was calculated in order to assess affordability for developing regions which may require a government subsidy. Future work would include manufacturing the fortified whey protein isolate powder and conducting subclinical trials to examine its effectiveness.Item Innopharma Education Library: As Open as Possible, As Closed as Necessary(2024-03)Presented at the Academic & Special Libraries Conference, Dublin, March 2024.Item Digital Skills Pathway Creating A Qualification Path For Various Career Stages(2023-11)Presented at QQI NFQ 20th Anniversary Conference, November 2023.
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