Process Validation

Process validation is a manufacturing-based activity to demonstrate a controlled and reproducible process to meet the required material specification. It is supported by laboratory experimentation which includes:

• determination of critical control parameters and their
  operating ranges appropriate for the facilities on which the process will be run
• scale-down modelling of limits of re-use (for example,
  columns) and other formal frameworks to assess risk and
  aid good scientific judgement
• extractables studies
• genetic characterisation and studies of cell banks
• good documentation to trace back and support developed rationales

These studies support the final process definition on the plant and dramatically reduce the likelihood of failure of validation batches.