GE Healthcare – Validation Documentation Gap Analysis and Update

Background

GE Healthcare is the $19 billion healthcare business of GE. GE is a leading provider of medical imaging, monitoring, biomanufacturing and cell and gene therapy technologies.

The GE healthcare site manufactures radioactive pharmaceuticals for imaging and therapy and is therefore regulated by the MRSA/FDA, HSE and also the Office for Nuclear Regulation. The plant has competing requirements regarding clean room air changes and radioactive containment.

Solution

HFL was awarded the contract to perform a gap analysis on existing validation documentation and close any gaps by updating documentation. This included P&IDs, control philosophy, SOPs, data sheets, DQ, IQ, OP and PQ protocols.