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Site Qualification Question

Hello All,

I’m very new to validation and this site and I can’t seem to find any information on this topic. When I talk to coworkers about this matter give me different answers on this topic. My question is when you move a piece of packaging and/or manufacturing equipment do you have to do the IQ/OQ/PQ over again, the IQ/OQ, or only the PQ?

Also, if anyone can give me good resources on validations that would be greatly appreciated. Thank you for your time and help.

How was this handled in the past, have you ever encountered this situation before?

Ask yourself a few questions like how far you are moving this piece of equipment, are the environmental factors going to change, will the same power supply be used to power it, ergonomically will that change.

There are a whole host of questions you need to ask yourself in order to come up with a true assessment of the level of revalidation that is required in order to sucessfully move the equipment.

I would suggest drafting a change request document with a series of typical questions that should be asked anytime a piece of equipment is used, and from that justify the level of revalidation that you are going to perform.

Hope that helps

[quote=seal]Hello All,

I’m very new to validation and this site and I can’t seem to find any information on this topic. When I talk to coworkers about this matter give me different answers on this topic. My question is when you move a piece of packaging and/or manufacturing equipment do you have to do the IQ/OQ/PQ over again, the IQ/OQ, or only the PQ?

Also, if anyone can give me good resources on validations that would be greatly appreciated. Thank you for your time and help.[/quote]

Dear Seal

Here u need to see how far the changes have been made, as Mr Graham said. As per WHO TRS 937 “5.2.5 Validation should be performed:
— for new premises, equipment, utilities and systems, and processes and
procedures;
— at periodic intervals; and
— when major changes have been made.
(Periodic revalidation or periodic requalifi cation may be substituted, where
appropriate, with periodic evaluation of data and information to establish
whether requalifi cation or revalidation is required)”.

Depending on the function and operation of the equipment, utility
or system, only installation qualification (IQ) and operational qualification
(OQ) may be required, as the correct operation of the equipment, utility or
system could be considered to be a suffi cient indicator of its performance.
Major changes like Installation at new plant require Full requalificaton.

[quote=seal]Hello All,

I’m very new to validation and this site and I can’t seem to find any information on this topic. When I talk to coworkers about this matter give me different answers on this topic. My question is when you move a piece of packaging and/or manufacturing equipment do you have to do the IQ/OQ/PQ over again, the IQ/OQ, or only the PQ?

Also, if anyone can give me good resources on validations that would be greatly appreciated. Thank you for your time and help.[/quote]

First ofll
you need a risk assessment to able to say something about your changing.
If your change will impact quality of product directly, it means you need requalification.
if your changes will impact on product quality indirectly u will need to make partial qualification or commisioning
if it doesnt impact your product quality, you dont need qualification
IQ-OQ depends on your change level as well. Because if you change something to be monitored, u should document it. And if this change will relevant its function, you should be sure its function runs properly (by OQ)
And, you change highly critical and you want to be sure it runs properly, you should repeat some OQ tests (functions) with product (PQ tests) and be sure product conforms specifications.
see you

Hi Seal,

As the equipment is old one and you are going to transfer from one place to another in such cases system suitability of that equipment need to be carried out if the equipment is critical one. System suitability consists two parts, one is of DQ, IQ and other is OQ. The report consists of “First interim report” and “Final report” consists of PQ.

Hope this you got.

Rgds-Uday Kharkar