Monty
Beginner
Posts: 6
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Usually after testing incoming raw materials and finding them acceptable, we place a release sticker on the container. But this is really a hassle for items that that are wrapped on pallets. There might be several pallets with 50 bags per pallet. Is it okay to just sticker a few bags per pallet ?
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IHN1
Member
Posts: 174
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In response to Monty
If your firm does not have a validated electronic inventory control system that prevents allocation of unreleased product to commercial production runs, and you rely on the physical tags to indicate status then absolutely not... you cannot sticker a few bags per pallet. You must unwrap the skid and label each individual bag irrespective of whether this action is a hassle or not.
Conversely if you do have a validated e-inventory control system that has the ability to restrict the allotment to only released materials, then the actual labeling is a redundancy.
As a rhetorical question if the first scenario is true at your firm, how would an operator in production verify the status of a bag of unlabeled material? I think that you would be hard pressed to prove adequate control over the charge-in of components, intermediates or finished products where only a percentage of bags are labeled.
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IHN1
Member
Posts: 174
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In response to IHN1
Oh and by the way, Morty welcome to the forum.
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IHN1
Member
Posts: 174
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In response to IHN1
Sorry for appearing to beat a dead horse but I found a reference to this very thing in the Canadian Q & A... good for reference.
Q.9 Are quarantine and release stickers required on all containers of raw materials and packaging materials?
A.9 Quarantine and release stickers are required on all containers of raw materials and packaging components to identify status when a physical quarantine/release system is used.
However, such stickers are not required when a validated electronic quarantine system which effectively prevents the possibility of inadvertent use of unreleased material is in place.
When fully computerized storage systems are used, backup systems should be available in case of system failure. (September 9, 2003)
http://www.hc-sc.gc.ca/dhp-mps/compli-conform /gmp-...
Point to consider if your firm is inspected by the UK MHRA this would hold force of law under MRA.
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JohanJ
Member
Posts: 229
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In response to IHN1
I need to concur with IHN.
a validated ERP/MRP system can perform this task. If you d o not have such a system then you need to put a sticker on th epallet, prefereably a tightly wrapped pallet so nothing can be taken off, or otherwise on each bag (recipient).
If you do not want to put stickers, you coudl also allow for having the items put in a quarantaine zone in which no-one is allowed to pick for production.
I would go for stickers if you do not have thrustworthy employees.
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