According to general standards and guidelines (ISO and GMP) the production process should guarantee a constant quality of drugs and medical devices. That is, each finished product must meet the requirements for safety and effectiveness, so there is a ‘ State of Control ‘. How can you control that process?
Continuous Process Verification
At this stage of the Process Validation we talk about Continuous Process Verification. The process is regularly verified that it still performs within the established criteria. By regular monitoring of facilities, installations, equipment, (computer) systems, processes and test methods is reliable information available.
Continuous Process Verification includes the following activities:
- Revalidation of sterilization processes
- Monitoring of processes and cleanrooms
- Statistical trend analysis
- Change management