Requalify or Not?

GOOD VALIDATION PRACTICE (cGVP)
1

I am being asked to sign of a CC for a relocation of a freezer -80 degree.

The CC says there is no requirement for any requal/reval.

They don’t have any SOPs that are specific. The freezer is used for QC samples.

They have no risk assessment .

Any guidance?

Thanks

2

[quote=mikey70]I am being asked to sign of a CC for a relocation of a freezer -80 degree.

The CC says there is no requirement for any requal/reval.

They don’t have any SOPs that are specific. The freezer is used for QC samples.

They have no risk assessment .

Any guidance?

Thanks[/quote]

What is a CC?
The relocation, does it involve dismantling the freeser completely and rebuilding it once located at it’s new location?
What do you mean by SOPs that are not specific?
What kind of risk assessment are you looking for?

The above questions are necessary to better understand your query and to be able to give guidance.

3

Hello Odracir,

  • CC - Relocation is via a change control.
  • Validation SOPs are not specific on wheter there needs to be requal/reval once the equipment is relocated.
  • There are no utililties for the freezer other than electric. So it will no be dismantled other than unplugged from the power supply.
  • With regards to to risk assessment, would they not need to evaluate what risks are involved when the equipment is moved i.e damage to components etc which could impact its functionality?

Thanks

4

[quote=mikey70]Hello Odracir,

  • CC - Relocation is via a change control.
  • Validation SOPs are not specific on wheter there needs to be requal/reval once the equipment is relocated.
  • There are no utililties for the freezer other than electric. So it will no be dismantled other than unplugged from the power supply.
  • With regards to to risk assessment, would they not need to evaluate what risks are involved when the equipment is moved i.e damage to components etc which could impact its functionality?

Thanks[/quote]

Thanks for the clearification of the abreviations.

What industry is this freezer going to be used in?

You may want to do a risk assessment if you think that the relocation/moving of the freezer has some concerns, i.e. quality concerns - impacting the product or QC samples.

If no utilities other than electricity is used and no dismantling of the freezer than an IQ (Installation Qualification) is required only - others here might differ on this view.

You can at this point introduce that a relocation SOP/relocation procedure to be added to the Validation Master Plan (VMP), so as to clearly/define what needs to be done by whom and how.

5

[quote=Odracir]Thanks for the clearification of the abreviations.

What industry is this freezer going to be used in?

You may want to do a risk assessment if you think that the relocation/moving of the freezer has some concerns, i.e. quality concerns - impacting the product or QC samples.

If no utilities other than electricity is used and no dismantling of the freezer than an IQ (Installation Qualification) is required only - others here might differ on this view.

You can at this point introduce that a relocation SOP/relocation procedure to be added to the Validation Master Plan (VMP), so as to clearly/define what needs to be done by whom and how.[/quote]

A minimal risk assessment would aid the change control document greatly. The previous poster asked regarding industry. I would take it a step further and say that the risk assessment should address the risk to the future contents of the freezer. The risk for an R&D stock supply of a critical reagent that cannot be replaced would be much higher than a freezer for off the shelf serum. The risk assessment can also address how “intense” the move will be. Is the move many miles long via a truck transport or being wheeled down the hall?

If personnel will be traveling with it, e.g. moving down the hall or nearby building, then it is expected that personnel will alert the appropriate group (quality, validations etc) if there is any potential problems (“oops”) during the move that could negatively impact performance.

Electricity should be verified, whether in an IQ or even a simpler document. Also if there is a database or other tracking mechanism for location of specific equipment, there should be some link/trigger to update that document.