> Process Validation
Process Validation
An API production process is considered validated when three successive lots for that API successfully meet the validation protocol requirements.
A validation protocol is established to specify how the validation process will be conducted and which criteria will establish acceptability. To evaluate which steps should be validated, the process is reviewed step by step from the point at which the final molecule that has physiological activity is formed. Every step that is critical to the quality of the final API is reviewed.
Following the validation exercise, a written report summarizes each of the three validation lot exercises. In addition, a final written summary report on the complete validation process includes a declaration as to whether the process is considered validated.