Identifying and assessing compliance risks in the manufacturing of sterile injectables within the Indian pharmaceutical industry
| dc.contributor.author | Reddy Goli, Ranjeeth | |
| dc.date.accessioned | 2024-07-02T15:57:07Z | |
| dc.date.available | 2024-07-02T15:57:07Z | |
| dc.date.issued | 2024-05 | |
| dc.description.abstract | The Indian Pharmaceutical industry is a global supplier of sterile injectable products, but in recent years, it has faced tougher regulations and demands for quality and compliance improvement. The research demonstrates that India is a major supplier of these life-saving drugs and hence authorities must seek strict compliance. The whole scheme relies on data collected from survey (surveys), and there was no in-depth analysis on the business factors that influence compliance. The purpose of the research is to raise the bar for sterile drug products quality and safety standards that are proactively identifying and rectifying compliance issues within the Indian pharmaceutical manufacturing systems. This study is aimed at exploring the views and involvement of the Indian pharmaceutical sector in ensuring conformity with sterile injectable drug production regulations. Our findings demonstrate a mix of opinions on the current regulatory model, and some of the participants voice their belief, whilst others express doubts about the level of compliance. Most of the responses are positive in maintaining sterile conditions during manufacturing, which are assured owing to cGMP adherence, with cleanrooms strictly monitored. The analysis brings a positive response to quality control measures, particularly training and education of the staff. Businesses that focus on their employee training are typically associated with higher confidence in production processes, quality control and effectiveness in operations. In fact, it can be asserted that high-quality control rigour, trust in the maintenance of sterile conditions, and the right infrastructure design are tightly correlated with each other as well. Although a well-established majority of respondents are confident in data security and robust infrastructure design; some do have a little anxiety which hints at the possible existence of weaknesses or obsolescence of the structures. The outcome of the study emphasizes the need for reliable quality systems, performing training regularly, installing systems of data integrity control and upgrading facilities for the manufacture of aseptic drug products in India. | |
| dc.identifier.uri | https://hdl.handle.net/20.500.14136/160 | |
| dc.title | Identifying and assessing compliance risks in the manufacturing of sterile injectables within the Indian pharmaceutical industry | |
| dc.type | Thesis |