Learnaboutgmp Community

Installation Qualification

Hi all,
In case a system is already up and running (being used) and is being retrospectively validated, how is the IQ for the same to be performed?
Do we need to show an IQ for the same in the first place?

Also,
If there are different instances of the application, one for development, one for testing and validation and the other production instance. Is it required to do an IQ for all the instances or is it sufficient to show that the system is properly installed if the recommended hardware and the installation procedure is followed only for one instance.

Regards,
Phani

[quote=phani]Hi all,
In case a system is already up and running (being used) and is being retrospectively validated, how is the IQ for the same to be performed?
Do we need to show an IQ for the same in the first place?[/quote]

My personal experience with IQs has been pretty positive. They (IQs) provide a nice means to document the configuration, ensure the system is set up properly, and provides a solid baseline for any future upgrades / changes. Keep in mind that the IQ/OQ/PQ paradigm is just a well-established convention. If you can justify that your system is validated by a different means, you are free to do so. Keep in mind, though, auditors tend to have a comfort level with what they know. Deviations from the de-facto standard often leads to more extensive investigation.

[quote=phani]Also,
If there are different instances of the application, one for development, one for testing and validation and the other production instance. Is it required to do an IQ for all the instances or is it sufficient to show that the system is properly installed if the recommended hardware and the installation procedure is followed only for one instance. [/quote]

If you can wrap it all up in a single IQ (maybe covering all the installation differences on the various instances?) then I wouldn’t see a need for separate IQs. Consider documenting your rationale (i.e., in a Validation Plan) for whatever direction you choose. Then, at least, there is solid justification for what you do end up doing.

[quote=phani]Regards,
Phani[/quote]

[quote=phani]Hi all,
In case a system is already up and running (being used) and is being retrospectively validated, how is the IQ for the same to be performed?
Do we need to show an IQ for the same in the first place?

Also,
If there are different instances of the application, one for development, one for testing and validation and the other production instance. Is it required to do an IQ for all the instances or is it sufficient to show that the system is properly installed if the recommended hardware and the installation procedure is followed only for one instance.

Regards,
Phani[/quote]

Hi Phani,
IQ must be perform on all the equipments whether the equipment model and configuration are same bit installation checks should be perform,
For existing equipments, which are existingly running, no IQ is required.

Well shanawaz! for a documented evidence it should be done wether it is an existing equipment or the new one. even IQ is essential for a used instrument or piece of equipment that is new to the site. It must also undergo installation qualification.

Dear Shahid, If the equipment is already in running (working) then there is no requirement of IQs ( no need to produce counterfeit document), just describe in qualification document that this subjeced equipment is using for long time ago and its working properly their installation is in true phase as well as operational part, the restroresptive data is available so it may cover IQ and OQ part, but for PQ you may challenge the equipment at worst case scnerio.
For new Equipments , IQ, OQ and PQ must be initiated.

Thanks

[quote=Shahnawaz]Dear Shahid, If the equipment is already in running (working) then there is no requirement of IQs ( no need to produce counterfeit document), just describe in qualification document that this subjeced equipment is using for long time ago and its working properly their installation is in true phase as well as operational part, the restroresptive data is available so it may cover IQ and OQ part, but for PQ you may challenge the equipment at worst case scnerio.
For new Equipments , IQ, OQ and PQ must be initiated.

Thanks[/quote]

By the way with same concept of reterospective data i gave the above statement, at least one should have proper informations documented for the audit purpose.

A bit late but just a quick one, if you do not perform an IQ then how are you ever going to know if everything is right and is in its right place?? Eg. main drive motor spec at 1425rpm slow speed and 2850 high speed, burns out. How will you know that it is like for like replacement if you have no DOCUMENTED EVIDENCE of the above specs??? Internal temperature cut out??
Sure, it might be operating perfectly, but what if?

Just something to tickle the mind.

Simulation Modelling Software
http://www.lanner.com
.provides a systematic method to check the system/equipment static attributes prior to normal.