PROCESS OPTIMIZATION, TROUBLESHOOTING OF TABLET PROCESS AND RISK ASSESSMENT

Tapan Das*, Dr. Jeevan Patel, Dr. Sudha Vengurlekar

The synopsis entitled “Process Optimization, Trouble Shooting of Tablet Process and Risk Assessment” is meant to improve manufacturing efficiency, reduce costs, and ensure product quality. Pharmaceutical manufacturers are seeking innovative solutions to optimize their manufacturing processes and troubleshoot potential issues. Process optimization involves first Identifying potential Issues, recognize common problems that can occur during tablet manufacturing, while Trouble shooting of tablet process involves various methods/ approaches to troubleshoot issues during tablet manufacturing and Risk Assessment involves conducting a risk assessment to identify potential hazards and mitigate risks. Process optimization uses various methods using the classic methodology by conducting experimentation followed by optimization. Certain techniques by using mathematical representation are also being followed. Troubleshooting is the diagnosis of symptoms of malfunction, and the process of determining and remedying the causes of these symptoms. There are various tools such as Failure Mode and Effect Analysis (FMEA) and Fault Tree Analysis (FTA) etc. for the trouble shooting. Risk assessment is an objective evaluation of risk which involves severity of harm, probability of occurrence and degree of detection of non-conformance. The test results of the model drug API are found to be meeting the predetermined specifications in accordance with the pharmacopoeia monograph. Similarly the in process results of various significant manufacturing steps and finished product meets the predetermined specification. The various remedial methods for each of the trouble shooting points are established. Based upon the optimized process very less number of trouble shooting are triggered leading to enhanced productivity and increased compliance. In addition the process automation techniques bring enhanced quality compliance.