Process Validation: Batch Size Increase in the Downstream Process

Abstract

The worldwide demand for the drug substance has increased by 30%. The drug substance is an ingredient used in the final product formulation, which later becomes the medicine that will reach the patients. The challenge that is faced is production limitations, which is driven by customer demand increased compared to previous years. Engineering uses historical data from the process to analyze and forecast the impact of the improvement. Then, the team captured key metrics to measure the impact of the implementation to validate if it was providing the planned yield. As a result of the implementation and validation strategy, the findings showed that flexibility to change different parameters and equipment functionality by reducing the amount of testing to confirm that the process fulfills the acceptance criteria included in the testing protocols, which includes Operation Verification, Performance Verification and Process Validation. Key Terms - Batch Size, Capacity increase, Drug Substance (DS), Process Validation (PV).