We offer process validation as an integral part of manufacturing as we know it is the key to your programme's success.
Process validation includes:
- Determination of key process parameters and their operating ranges appropriate for the facilities on which the process will be run
- Scale-down modeling of limits of re-use (for example, columns) and other formal frameworks to assess risk and aid good scientific judgment
- Extractables studies
- Good documentation to trace back and support developed rationales