Operational qualification
The Operational Qualification ( OQ ) (engl. Operational Qualification), the individual components of a conditioning / carried out to check the correct functioning of the device. The OQ is part of the qualification . The test procedures and acceptance criteria must be defined and approved in advance. This is regulated in the form of an OQ qualification plan.
General activities
Wherever possible, the functional qualification is carried out shortly after the installation qualification. The activities during the functional qualification are z. B .:
Review of the (pharmaceutically) relevant operational functions and measuring points, these are laid down in the specification (requirement specification), along with others.
target
The OQ thus ensures that the system built as part of the installation qualification (IQ) works in accordance with the requirements of the user and thus in accordance with the specifications (requirement specification) and that sufficient documentation exists as evidence of this. This is ensured in the form of an OQ qualification report.
literature
- Qualification and process validation of the company "Muster" for pharmaceutical manufacturers, BAH Bonn (3rd edition 2006)
- Validation plan according to SOP