When is an IQ/OQ needed

[hahe0104]

This post is in reference to 1100 series HPLC
I have two questions first. If the OQ was performed before the IQ was done is the OQ still valid?
The second question is . If right after the OQ was performed I noticed that the mulitiChannel gradient valve was not working and needed to be replaced. If I replace this do I need to have another OQ done on the instrument ? Or what if I get a whole new QuatPump then will I need another OQ?
Are there any suitability test that I could perform to qualify the new part or do I need to go through on outside vendor.
This instrument will be used to Validate a GMP method. Any feedback would help
Thanks,
hahe0104

[KM-USA]

The second question is . If right after the OQ was performed I noticed that the mulitiChannel gradient valve was not working and needed to be replaced. If I replace this do I need to have another OQ done on the instrument ? This instrument will be used to Validate a GMP method. Any feedback would help

A service vender we use has a document which states that the system must pass the pump gradient test after a MCGV repair (for the cGMP qualification).

[DR]

The answer to every one of your questions is in your departmental or company's SOP manual. If this is not so, your manual needs work.

[aceto_81]

This post is in reference to 1100 series HPLC
If right after the OQ was performed I noticed that the mulitiChannel gradient valve was not working and needed to be replaced.

If you find this out after your OQ passed, then your OQ procedure isn't good enough!

Ace

[GaryR]

If you are operating in a regulated environment, as noted, you should have a standard operating procedure (SOP) describing the steps necessary to commission and validate (verify) new equipment and to show ongoing performance verification.

IQ: Installation Qualification. (Usually) performed by the Vendor to their specifications to show that the instrument is installed correctly, i.e. correct power supply, ventilation, services, instrument control etc.

OQ: Operational Qualification. (Usually) performed by the Vendor to show that the instrument will operate correctly to the Vendor's performance specifications. MUST be preceded by IQ (if the instrument is not installed properly, how can you test if it is operating properly?)

PQ: Performance Qualification. (Also call 'calibration' or 'verification') (Usually) performed by the owner/operator to a set schedule, or if the instrument is moved or serviced. Frequency should be determined by risk assessment (high risk = high frequency; low risk = lower frequency). Procedure (SOP) usually based on the Vendor OQ procedure to show that the instrument is continuing to operate as designed.

If the instrument fails to meet the acceptance criteria at any stage, the problem must be rectified and the test repeated. Every stage needs to be fully documented, checked and approved prior to proceeding to the next stage.