FDA´s Process Validation Guidance and Annex 15 to the EU GMP Guide require manufacturers to monitor product quality to ensure that a state of control is maintained throughout the validation 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 also 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/OPV signals and defining types of responses to these signals. However, real-life data of pharmaceutical and biopharmaceutical processes rarely meet the fundamental assumtioms of the conventional SPC (Statistical Process Control), This in turn leads often to false signal alarms, which entail futile investigations of innocuous events. Thus, a practical approach is called for and it consists of collecting, charting and evaluating product and process data under relaxed and adjusted SPC rules, allowing a streamlined implementation of the CPV/OPV program.