Regulatory Landscape and comparative analysis of Manufacturing Execution System (MES) Software and Computer System Validation (CSV) Process in Pharmaceutical manufacturing facilities in India
| dc.contributor.author | Madackal Kuriakose, Tony | |
| dc.date.accessioned | 2024-07-03T08:28:59Z | |
| dc.date.available | 2024-07-03T08:28:59Z | |
| dc.date.issued | 2024-05 | |
| dc.description.abstract | Pharmaceutical manufacturing facilities constantly works on providing the people lifesaving drugs. Documentation is a vital process in the lifecycle of a drug. Batch records reflects the quality of specific lots of drugs manufactured. All industries are currently undergoing Digital Transformation and pharmaceutical manufacturing facilities are no exception. The main purpose of these research is to comparatively analyse Manufacturing Execution System (MES) Software and Computer System Validation (CSV) Process in Pharmaceutical manufacturing facilities with different regulatory landscape in India and to evaluate whether the proposed technological platforms are effective in reducing the data integrity issues. The health regulatory system of India, The Central Drugs Standard Control Organization (CDSCO) provides only limited information regarding the Manufacturing Execution System (MES) Software and Computer System Validation (CSV) Process. In conclusion, majority of the pharmaceutical manufacturing facilities operating in India follows strict regulatory systems like U.S. Food and Drug Administration (US FDA), Medical and Healthcare Products Regulatory Agency (MHRA), The European Medicines Agency (EMA), The National Health Surveillance Agency (ANVISA), Therapeutic Goods Administration (TGA), and Health Canada. At the same time, India has several small-scale pharmaceutical manufacturing facilities for supplying drug products to domestic markets and third countries like Africa, Nigeria, Zimbabwe, Uganda, Philippines, Sudan, Tanzania, Kenya, Ghana, Namibia, and Sri Lanka which are not highly regulated as the former regulatory systems. Strict and accepted regulatory systems have advanced technologies and are continuously promoting digitalization. In addition, the study also helps other researchers to understand about the regulatory landscape of India and supportive measures the Government should initiate for the implementation of Manufacturing Execution System (MES) Software and Computer System Validation (CSV) Process. | |
| dc.identifier.uri | https://hdl.handle.net/20.500.14136/161 | |
| dc.title | Regulatory Landscape and comparative analysis of Manufacturing Execution System (MES) Software and Computer System Validation (CSV) Process in Pharmaceutical manufacturing facilities in India | |
| dc.type | Thesis |