Guide to GAMP 5, data integrity and quality by design GxP manufacturing

What is a GxP manufacturing system? Any computerized system controlling the manufacture of a GxP product, such as a pharmaceutical drug, is defined by the International Society for Pharmaceutical Engineering (ISPE) as a manufacturing system.

A manufacturing system provides real-time control, collects and manipulates data, and typically offers a physical interface between systems, such as connecting a programmable logic controller (PLC) to your Distributed Control System (DCS).

Above all, your manufacturing system should incorporate the FDA’s principles of Quality by Design (QbD), as we’ll see in this presentation.