Undertaking process validation involves a major commitment in terms of personnel, resources, time, and money. Performing prerequisite verifications can reduce the risk of making costly mistakes. This ...

Overview: Process Validation is required by FDA and most regulatory bodies. PV demonstrates consistency of pharmaceutical processes. PV requires writing and executing a validation protocol that ...

Continued process verification for a cleaning validation program begins once the validation study is complete. Continued process verification (CPV) for a cleaning validation (CV) program begins once ...

The track by which API manufacturing processes are prepared for commercial use is comparable to overlapping integrative process evaluations at commercial scale. This ensures the process is ...