Monday, 31 January 2011

Enabling equipment qualification and GMP compliance

GE Healthcare is launching Installation Qualification (IQ) and Operational Qualification (OQ) protocols for ImageQuant LAS 4000 mini, 4000 and 4010 biomolecular imagers. Required for controlled environments, the protocols enable ImageQuant systems to comply with regulatory and Good Manufacturing Processing standards (GMP). The protocols have been developed in accordance with recent guidelines, including GAMP5 and ASTME2500, and highlight data integrity and product quality.

The IQ protocol is carried out during installation of the ImageQuant system and demonstrates that the device has been set up correctly and adheres to regulatory guidelines. The subsequent OQ protocol is performed to ensure that the instrument functions as intended.

Both qualification protocols must be performed by a certified GE Healthcare Service Specialist. The resulting validation documents are uniform, simplifying document handling for all stakeholders. As required by current regulatory guidelines, the protocols have been reviewed by Subject Matter Experts to ensure compliance.

The ImageQuant IQ/OQ document package includes:

* Protocols describing the objective and acceptance criteria of the different tests included in the IQ/OQ.
* Record sheets for each test module with descriptions of the qualification criteria.
* Reports summarizing the IQ/OQ results.

GE Healthcare