The integration of process analytical technologies, concurrent validation, and parametric release programs in aseptic processing.

摘要

Approaches such as process analytical technology (PAT), concurrent validation, and parametric release have a common purpose. The purpose is to improve product and process quality control by monitoring and utilizing on-line and in-line measurements at critical controls points and phases in the manufacturing operation. This paper discusses how the integration of PAT, concurrent validation, and parametric release programs (collectively referred to as "quality enhancement programs") can be used to improve product quality during manufacturing, and can result in economic and efficiency improvements for the industry. All of these quality approaches emanated from the risk assessment and critical point analyses engendered in the hazard analysis and critical control points (HACCP) concept (3-6).