This repository is a collection of research and scholarly output from Innopharma.
Recent Submissions
Item A Comparative Analysis of Paper-Based vs. Electronic-Based Equipment Qualifications in Medical Device Manufacturing of Implantable Orthopedic Devices within the European Union: Technological, Regulatory, and Operational Impacts(2025-05)The medical device industry is highly regulated, where documented evidence of medical device manufacturing equipment qualification is a critical step to ensuring regulatory compliance, patient safety and device performance. This study undertook a comprehensive comparative analysis of paper-based and electronic-based equipment qualification (EQ) processes in the manufacturing of implantable orthopedic devices, assessed under the regulatory framework of the European Union Medical Device Regulation (MDR). The study critically evaluated the technological, regulatory, and operational impacts, with a particular emphasis on compliance, operational efficiency, and data integrity. The research was guided by the hypothesis that electronic-based EQ systems demonstrate superior capability in meeting the stringent regulatory requirements of the MDR, provide enhanced operational efficiencies, improve traceability, and documentation practices compared to traditional paper-based systems. A positivist philosophy, using a deductive approach, mono-method, quantitative research strategy in the form of a survey with a cross-sectional timeline, supported the aim of this research study. The survey/questionnaire was created using Microsoft Forms. The target audience were eligible participants with experience, either directly or indirectly, of paperbased and/or electronic-based EQ systems within the medical device industry. The survey was distributed via email and LinkedIn, a shortened URL link to the questionnaire was embedded within the invitation. The survey achieved 187 responses in total. The data was analysed using Minitab software application. The findings offered critical insights into the advantages and challenges associated with transitioning to or maintaining electronic-based EQ systems in highly regulated medical device manufacturing environments. Although the implementation of electronic systems requires upfront investment and training which can be seen as time-consuming, electronic systems significantly reduce major challenges such as human error. The transition from paper-based to electronic-based qualification systems has been overwhelmingly positive from a regulatory, operational, and quality standpoint. 74.43% of the participants agreed that technology has positively influenced the EQ process. The impact of the MDR has been felt to varying degrees across manufacturing facilities. Approximately 96% of the respondents reported no impact/positive impact on the EQ process since the introduction of the MDR. The study concluded that electronic-based EQ systems are not only justified but increasingly essential for manufacturers of implantable orthopedic devices within the European Union. Transitioning to electronic-based EQ systems optimises compliance and operational agilityItem Evaluating the effectiveness of supplier quality management practices in enhancing supply chain performance within pharmaceutical quality management systems(2025-05)This study investigates the implementation and effectiveness of Supplier Quality Management (SQM) practices in organizations, focusing on these practices influence on supply chain reliability, regulatory compliance, cost efficiency and technological integration. The core objective was to identify which factors significantly affect SQM effectiveness and how organizations respond to challenges and opportunities in supplier management. In this research, a positivism philosophy with deductive approach is adopted to examine the impact of SQM on supply chain performance. A quantitative, cross-sectional research methodology was used, with data collected through structured questionnaires and non-probability purposive sampling was applied to target industry professionals. Data analysed by SPSS including descriptive statistics to determine variable relationships and the capabilities of selected variables. In the process all ethical procedures are duly abided and followed. The findings of this study indicated a moderate level of SQM adoption across the sample, with variability in how frequently audits are conducted and how advanced technologies are integrated into quality systems. Notably, a significant positive correlation between SQM practices and regulatory compliance strengthens the industry standards and technology use is positively linked to cost efficiency, indicating the reduction in operational costs. Conversely, a significant negative correlation between the effectiveness of quality agreements and supply chain reliability, suggests a mismatch in expectations or execution. Regression results demonstrated that the model explained approximately 14.9% of the variance in SQM practices indicating a moderate relationship between the predictors and dependent variable. The ANOVA test supported the model’s statistical significance (F = 3.037, p = .009), confirming that the selected independent variables collectively have a meaningful impact on SQM outcomes. In conclusion, SQM practices significantly improves supply chain performance by the use of advanced technologies, enhancing regulatory compliance and operational efficiency but challenges remain in aligning with supplier non-compliance and reliability. Furthermore, future research should consider these insights for continuous improvement, strategic investment in digital tools and stronger supplier collaboration frameworks to support long-term quality objectives.Item Assessing the Efficacy of Process Analytical Technology (Pat) in Detecting Out-of-Specification (Oos) Results During Pharmaceutical Manufacturing(2025-05)In this study, it was shown that Process Analytical Technology (PAT) is an effective tool in improving product quality and reducing Out-of-Specification (OOS) results during pharmaceutical manufacturing in India. The research aimed to evaluate the adoption and challenges of PAT, with a focus on its role in detecting Out of Specification results, process deviations and monitoring Critical Quality Attributes (CQAs) in real-time. A survey of 123 experienced professionals from various sectors of the Indian pharmaceutical industry was conducted and Quantitatively analysed to assess the effectiveness, barriers, and opportunities for PAT implementation. The results revealed the PAT’s ability to detect OOS results and improve process control compared to conventional methods. PAT also helped to identify CQAs accurately, thus allowing early interventions and minimizing potential product recalls. Despite the overwhelming recognition of PAT’s benefits, several challenges were identified that impede its full adoption. These includes Technical Barriers, Resource related barriers, Regulatory Challenges as well as Organisational Barriers The study concludes that while PAT is highly regarded for its ability to enhance product quality and manufacturing efficiency by the real time monitoring of OOS results and process deviations, its widespread adoption in the Indian pharmaceutical industry is hindered by technical, financial, regulatory, and organizational challenges. To address these issues, the study recommends the implementation of regular and up to date training programs, development of cross-functional PAT teams, and stronger engagement with regulatory bodies to simplify approval processes. The findings also suggest that academic institutions should incorporate PAT into curricula to build a skilled workforce capable of supporting its integration into industry practices. These findings provide valuable insights for industry practitioners, policymakers, and educators aiming to foster more effective use of PAT in pharmaceutical manufacturing, ultimately contributing to improved operational excellence and product quality in the sector.Item Clear Medication Labels for Better Public Health Outcomes: Tackling Non-Adherence in India(2025-05)In the context of India’s diverse linguistic and educational landscape, medication label clarity plays a critical role in promoting safe and effective medicine use. This study investigates how the clarity of pharmaceutical labelling affects patient adherence, with particular attention to language accessibility and visual design. The primary aim was to examine the impact of label clarity on adherence, while secondary objectives included identifying barriers to comprehension, assessing public health implications, and proposing actionable recommendations. A quantitative survey method was employed, with responses gathered from 142 participants to examine how label design, language accessibility, and digital tools influence patient comprehension and medicationtaking behaviour. The findings revealed that over half of participants reported occasionally or frequently deviating from label instructions. This behaviour was closely linked to factors such as complex terminology, small font size, and the exclusive use of English on labels. In contrast, respondents who encountered clear, visually accessible labels with simplified language and pictograms reported better understanding and adherence. The results further demonstrated a strong public preference for multilingual labelling, colour coding, and the integration of QR codes and digital tools to support comprehension, especially among diverse linguistic groups. An overwhelming majority of 95.8% of respondents considered label standardisation important for patient safety and public health. These insights highlight the urgent need for pharmaceutical labelling reform to ensure inclusivity, reduce preventable medication errors, and improve health outcomes. This dissertation concludes by offering practical and policy-oriented recommendations. These include the adoption of user-friendly design features, incorporation of regional languages, and digital enhancements, with suggested implementation through national regulatory bodies like the Central Drugs Standard Control Organisation (CDSCO). Limktations of the study are acknowledged, particularly the absence of inferential analysis, and future research is recommended to explore causal links between label improvements and long-term adherence behaviour across wider populations.Item Evaluating the Role of Process Analytical Technology (PAT) in Enhancing Pharmaceutical Manufacturing Efficiency in India(2025-05)This study investigates the impact of Process Analytical Technology (PAT) on manufacturing efficiency, product quality, regulatory compliance, and cost-effectiveness in the Indian pharmaceutical industry. PAT, an advanced technology framework introduced by the U.S. Food and Drug Administration (FDA), enables real-time monitoring and control of critical process parameters during pharmaceutical production. The research aims to assess the key drivers and barriers to PAT adoption, evaluate its influence on operational performance, and propose strategic recommendations to enhance its wider implementation. A quantitative research methodology was employed, collecting data through surveys from 182 pharmaceutical industry professionals, including production managers, quality assurance personnel, and regulatory compliance officers. These professionals were selected based on their direct involvement in PAT implementation. The data were analyzed using statistical tools such as SPSS, Microsoft Excel, and Tableau, which provided insights into the effectiveness of PAT in improving manufacturing outcomes The results revealed that PAT adoption positively impacts product quality, operational efficiency, and regulatory compliance, with many organizations reporting reduced batch failures, improved product consistency, and enhanced real-time monitoring of manufacturing processes. However, the study also identified significant barriers to PAT adoption. High initial investment costs, a shortage of skilled workforce, and complex regulatory requirements were found to hinder widespread implementation. Based on these findings, the study recommends addressing these challenges by providing financial incentives, improving workforce training, and offering regulatory support to facilitate smoother integration of PAT. Furthermore, the research emphasizes the importance of exploring the long-term impact of PAT on manufacturing efficiency and the potential role of external collaborations in overcoming the barriers to adoption. This research provides valuable insights for industry stakeholders and policymakers, highlighting the importance of PAT in optimizing pharmaceutical manufacturing processes in India. It contributes to a better understanding of how PAT can enhance manufacturing viii efficiency while ensuring regulatory compliance, ultimately fostering industry growth and competitiveness in the global pharmaceutical market.
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