How Can Quality by Design Enhance Biopharmaceutical Manufacturing in India? Exploring Strategies and Outcomes
| dc.contributor.author | Cheeramkulath Jose, Merin | |
| dc.date.accessioned | 2024-10-17T09:59:27Z | |
| dc.date.available | 2024-10-17T09:59:27Z | |
| dc.date.issued | 2024 | |
| dc.description.abstract | This study investigates the integration and impact of Quality by Design (QbD) principles within the Indian biopharmaceutical manufacturing sector. As the industry expands, driven by the demand for affordable biologics and the necessity to meet stringent international quality standards, QbD emerges as a pivotal approach. This research evaluates the current level of QbD integration, explores specific strategies employed by manufacturers, and analyses the outcomes on product quality, regulatory compliance, and operational efficiency. It also identifies significant barriers to QbD implementation, including technical expertise gaps, high upfront investment costs, and regulatory challenges. The study is based on a comprehensive survey conducted among industry professionals. The survey employed structured questionnaires designed to collect quantitative data on the perceptions, experiences, and practices related to QbD implementation within the sector. Data analysis was performed using statistical methods, including descriptive statistics to summarize the data and inferential statistics to explore relationships between variables, assess the impact of QbD practices, and identify significant trends within the industry. The findings reveal that while QbD is widely recognized for its potential, its implementation remains in the early stages across much of the industry. The results highlight the need for enhanced training, investment in advanced technologies, and stronger regulatory alignment to facilitate broader and more effective QbD adoption. These insights are intended to guide policymakers, industry leaders, and regulatory bodies in strengthening the Indian biopharmaceutical sector through the effective application of QbD principles. | |
| dc.identifier.uri | https://hdl.handle.net/20.500.14136/188 | |
| dc.title | How Can Quality by Design Enhance Biopharmaceutical Manufacturing in India? Exploring Strategies and Outcomes | |
| dc.type | Thesis |