⇒ continued process verification(The stage 3 “Continued Process Verification” is a new step in validation. Also legacy process should be (re)validated regarding this life cycle. The start is stage 3 “Continued Process Verification”. The goal of the third validation stage is continual assurance that the process remains in a state of control (the validated state) during commercial manufacture. A system or systems for detecting unplanned departures from the process as designed is essential to accomplish this goal, says the Guidance. Now, also the EU requires Ongoing Process Verification as part of a Validation Life Cycle.)
pharmadvisor.ru CRINKUM-CRANKUM); постоянная верификация производственного процесса (документальное подтверждение того, что во время промышленного производства процесс находится в контролируемом состоянии CRINKUM-CRANKUM)