Continued Process Verification – in a nutshell!
OK, so you have come through Process Design and Process Qualification. The Commercial train is steaming ahead. However, to take it back to basics, there are 3 stages of Process Validation, the 3rd been Continued Process Verification. Naturally, as the 3rd and final element, it is often left aside or not given proper attention.
The aim of continued process verification is to ensure a validated process stays in control, or in a state of compliance.
Information within the scope of Continued Process Verification can include:
Defects and Complaints reporting
Deviations and CAPAs
Trending of outputs against lines/shifts/personnel, preventative maintenance schedules
Reviewing Batch to Batch Variation
A correct approach to Continued Process Verification will help to ensure that a process remains within its validated state during the commercial lifecycle. Furthermore, it should help to identify problematic trends before they start to effect product quality.