Importance of the OQ – Operational Qualification
- Documented proof that the installations, systems and plants operate properly over the entire intended operating area in the installed or modified version. (Aide Memoire GMP, inspection of qualification and validation in pharmaceutical production and quality control).
- Documented verification that installations, plants and equipment, in the form that they were installed or modified, operate in accordance with expectations within the scope of the intended operating ranges. (EC-GMP Guidelines, Annex 15)
- A prerequisite for the OQ is that the IQ has been successfully completed.
- Within the scope of the OQ, the function of the technical system is checked for compliance with the functionalities as defined in the requirement specifications.
- Documentation
- Plan for implementation of the OQ
- Test reports for the various functionality tests
- Calibration of the measuring points (determination of calibration intervals)
- Verification of electro-magnetic compatibility
- Identification and verification of the quality-influencing functions
- Review of the risk analysis
- Check of individual functions
- Check of performance parameters
- Check of ambient conditions
- Creation of work instructions in the context of existing operating instructions
- Adjustment of work instructions for calibration and maintenance
- Creation of a logbook
- Report on the implementation of the OQ
- Verification of the technical documentation supplied by the supplier
- Completeness check
SEEFRIED Verfahrenstechnik GmbH supports you with the compiling of documentation and verification of the OQ – Operational Qualification.