Process Validation Considerations

Process validation is crucial for successful registration and commercial manufacturing. Its primary objective is to prove that the manufacturing process can reliably produce products of acceptable quality under commercial manufacturing conditions. Process validation encompasses a series of activities throughout the product and process lifecycle and should not be viewed as a one-time event or action taken right before a commercial launch. Adopting this lifecycle approach assures regulatory authorities that the process is consistently and reliably under control. Continue reading to learn how to determine the right timing and properly apply a risk-based approach.