Process validation includes a series of activities taking place over the lifecycle of the product and process. The three-stage life cycle links product and process development to qualification and Continued Process Verification in order to control variability and maintain the process in a state of control until product discontinuation.
Effective validation may represent a significant decrease of costs. A validation not performed in an efficient manner may represent a loss of productivity or waste. For companies it is a challenge to quantify validation in terms of hours for each activity and find the best option to ensure quality.
The following services can be offered
- Process validation:
- Life cycle approach, CQAs, CPPs, CMAs
- Continued Process Verification
- Risk-based control strategy according to variability
- Cleaning validation, clean and dirty holding time
