VALIDATION IN-PROCESS CONTROL

Process control systems are being increasingly introduced in pharmaceu tical production plant. They exercise quality-relevant functions and a re thus subject to legal requirements of validation. It must therefore be established and documented that a process control system fulfills specific requirements. The technical part of this task lies in qualifi cation of the process control system. The present article described th e basic principles of such process control system qualification, servi ces for setting up a process control system with obligatory validation , qualification-oriented control system functions, and support of the control system manufacturer in validation.