Hi, I work for a Contract Manufacturing Company and we are attempting to set up IQ for our equipment and are struggling with tyring to understand from an FDA standpoint what all we need to be looking at during our validation run for the IQ. When reading the GHTF document, it was specific to the installation of the equipment, however, we have individuals telling us that we also need to verify placement, linespeed, what size boards the machine is capable of running etc.. This does not correlate with the what the GHTF document is stating. Can anyone advise what we need to focus on during IQ? Is it all encompassing or just installation?

Welcome to the wonders of validation. There are varying opinions on what must be included but genenerally validation of equipment is essentially the collection of data to prove tha the equipment is designed, installed and operates properly. In most firms this collection of data is in the florm of protocols called IQ, OQ, PQ. The sum of these will work toward a final conclusion that the equipment is ready and able to perform to meet the desired result.
Therefore in your validation plan, give an overview of what you plan to do at each stage.
IQ requires a formal and systemic check of all installed equipment against equipment suppliers specifications and additional criteria identified by the useras part of th purchase specifications.
OQ identifies the sutis to be underatken on the critical variables.
In some cases these two are combined as IQ/OQ but it is up to you.
Just remember that the validation package is to encompass all aspects of he process to meet the burden of proof that the equipment works as intended.:)

Don, good explanation, but what did you mean to type for "sutis"?

:bonk: teach me to type things before I have my coffee.
I should have typed: OQ identifies the studies to be undertaken on the critical variables.

Hi, I work for a Contract Manufacturing Company and we are attempting to set up IQ for our equipment and are struggling with tyring to understand from an FDA standpoint what all we need to be looking at during our validation run for the IQ. When reading the GHTF document, it was specific to the installation of the equipment,

This is my understanding.

however, we have individuals telling us that we also need to verify placement, linespeed, what size boards the machine is capable of running etc.. This does not correlate with the what the GHTF document is stating.

Placement may be a part of installation, and thus, the IQ. The rest sounds like an OQ.

Can anyone advise what we need to focus on during IQ? Is it all encompassing or just installation?

That's what I understand to be the role of IQ - the physical installation of the equipment. OQ is the generic operation of the equipment - like you mention above - operating speed, what it's capable of running - sort of a min/max determination. PQs validate that the machine can process individual products - sort of an optimization exercise.

As an aside, we had the pleasure of hosting the FDA for four days last week and they didn't look at one IQ, OQ or PQ. They did hit our cleaning validation pretty hard though.

Have you done a Master Validation Plan? I would strongly advise you to do so.

You can look at an example of a validation plan here (http://www.clinivation.com/docs/procedures/mfgeng/ProcessValidation.doc?PHPSESSID=575b6d4bdc5d472e955015b5e577e62b). There are some more templates on clinivation's web site. (http://www.clinivation.com/pages/resources/downloads.php#protocols)