The final check
Process validation is the final piece of the validation process that a medicine production line undergoes before commercial production can start. During this phase, our engineers formally check all previous validation and qualification actions. This includes equipment qualification, cleaning validation, master batch records and staff training. We also verify the quality of the first commercially produced batches and we link them to the critical process parameters.
Process validation - Advipro @ your service
- Defining the process validation strategy
- Implementation & reporting of validation studies
- Underpinning bracketing strategy in case of multiple presentations of the same product (possibly with different strengths) to reduce the number of process validation batches to be performed