Validation of process control systems in the pharmaceutical industry

Abstract

Process control systems for pharmaceutical production plants have to be designed, installed and commissioned in accordance with specific quality assurance measures to ensure high operational safety and compliance with regulatory requirements. These measures must be documented carefully as the results will be presented to regulatory authorities upon inspection as proof of compliance. The overall process is called validation and the subset of measures relevant for technical systems is called qualification. This paper presents a concept for prospective qualification of process control systems based on the integration of qualification measures into the control system design, installation and commissioning process.