The EU GMP and FDA regulatory documents require manufacturers to monitor product quality to ensure that a state of control is maintained throughout the lifecycle of new products and legacy products during the third process validation stage called Continued Process Verification (CPV) or Ongoing Process Verification (OPV). Indeed, regulatory agencies expect manufacturers to implement a CPV plan as reflected in FDA warning letters.
The implementation of Stage 3 is translated into establishing an ongoing CPV/OPV program which allows Identification of CPV Signals and defining types of responses to these signals. However, applying traditional SPC (Statistical Process Control) rules my lead to false signal alarms. Thus, collecting, charting and evaluating product and process data under relaxed and adjusted SPC rules allow a practical and streamlined implementation of the CPV/OPV program.