Process Validation

Process Validation combines the actual validated facility, utilities, equipment, and the trained personnel with the commercial manufacturing process, control procedures, and components to produce commercial batches. A successful process validation will confirm the process design and demonstrate that future commercial manufacturing process performs as expected. Process Validation will typically have a higher level of sampling, additional testing, and greater scrutiny of process performance than would be typical of routine commercial production. The level of monitoring and testing should be sufficient to confirm uniform product quality throughout the batch.

PSC can offer assistance with Process Validation. Our skilled personnel can work with your operations and quality groups to generate process validation protocols, facilitate execution, collate documentation and generate reports. Our consultants can provide advice on Process Simulation testing, environmental monitoring during process validations, and regulatory requirements with respect to batch sizes and number of replicate runs.