Analytical Method Technology Transfer From Quality Control Laboratory To Manufacture Area

Abstract

The project was developed with the intent to document the analytical transfer method to reduce in-process concentration testing cycle time. A reduction of up to 50% turnaround time (TAT) downtime was achieved. Waste reduction due to no sample preparation, gowning cost reduction, since there is no need for the operators to take the sample to the Quality Control (QC) laboratory and transferring the in-process method to the manufacturing area allows more capability to the QC laboratory to perform another testing were other improvements obtained from the project. Technology method transfer tools were applied to generate a successful in process method transfer from the QC laboratories to the manufacturing area. The implementation of this project complying with all the standards required by the company and the different regulatory agencies will improve the capability and competitiveness of the manufacturing area among the company sites. Key Terms ⎯ Analytical Method Transfer, Manufacturing Process, Protein Concentration, Turnaround time (TAT) reduction.