D
Denis
Visual status of finished goods
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?
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?