GMP Inspection Requirements - Eliminating Visual status of finished goods

[Denis]

Hi
We have an issue with the visual status of finished goods.

We manufacture sterilised alcohols in 1 & 5 litre bottles, IMS and IPA. These bottles are packaged into sales units of 4 or 6 bottles into a cardboard case.

These sales units are palletised and sent for irradiation. Upon return for irradiation the pallets are sent to our Finished Goods Warehouse.

The product is then inspected by the use of a sampling plan.

All the pallets are broken down and each individual case is stamped "QC Approved".

This task is very labour intensive and time consuming.

I do not see the reason for this activity.

We clearly have documented procedures for inspection after irradiation and supporting inspection records.
I would like to cease this activity (a result of an over zealous auditor ) .

Any comments, concerning cGMP?

[SteelWoman]

You can identify when "final inspection" takes place in your process. I'm assuming that PRIOR to irradiation you perfrom some kind of final inspection, right? If the irradiation process (which I admit I don't know that much about) simply PERMEATES the skids of material but doesn't impact it in any other way, I think you could make a case that your final inspection was prior to the irradiation, and that the only other inspection that might be necessary is a visual inspection of the skids once they return from irradiation for any obvious handling damage.

Just IMHO, of course.

[Rob Nix]

Another question is, how does one know that the material has went through irradiation? How do you identify processing status, other than the QC stamp?

[Denis]

The supplier who provides us with the irradiation process applies an in process batch code ( for their own Quality system purposes), this batch code label turns red once irradiated.

They also supply us with a certificate of irradiation as proof, again we audit their Quality system as part of our approved supplier assessment on an annual basis.

[Cathy]

Dennis, I agree with you and a visual inspection of this nature appears to be unneccessary. Have a question - have you ever rejected material from this post-irradiation inspection and if so what was the reason?

My knowledge of irradiation is somewaht limited, but from what I can remeber the individual product is not handled by the steriliser (?). if this is the case then your pre-irradiation inspection should be sufficent for release purposes.

What you can do, for piece of mind is ask the steriliser what final inspection they carry out - do they open cases for visual inspection? If not, you could ask them to do this for you.

One other thing, why does the product go into storage in the warehouse before it is inspected? maybe, if you must keep the inspection going, you could save time and effort by reducing the sample plan and doing the inspection as it comes in to the warehouse?

Just IMO...

[Al Rosen]

Denis:

You referenced the cGMP when you posted. I don't know if the folks out there realize that the FDA has a requirement for sampling and inspecting pharmaceutical labelling at the completion of all processes. Cathy's point about performing an inspection prior to wharehousing is a good one. I'm not an expert on pharma, so I think you might want to look at those FDA regs very closely before making any changes.

[gpainter]

What does your customer and regulations require?