Can incoming and outgoing areas be allocated inside the store?

T

twix38

Hi guys. I understand that the incoming area should be separated from the storage area for medical devices. My question is, can we have the following designated areas all in one premise, sharing the same room (i.e., store) as where the devices are kept?
1. incoming area
2. outgoing area
3. scrap area
4. expired stocks
5. quarantined area
6. demo items

The above areas are segregated clearly from the devices (stored on the racks), and labelled accordingly.

Is this kind of arrangement still comply to ISO 13485 and GDP standards? Please advise. Thanks.
 

somashekar

Leader
Admin
Hi guys. I understand that the incoming area should be separated from the storage area for medical devices. My question is, can we have the following designated areas all in one premise, sharing the same room (i.e., store) as where the devices are kept?
1. incoming area
2. outgoing area
3. scrap area
4. expired stocks
5. quarantined area
6. demo items

The above areas are segregated clearly from the devices (stored on the racks), and labelled accordingly.

Is this kind of arrangement still comply to ISO 13485 and GDP standards? Please advise. Thanks.
Why not ?
When the demarkation is good and the storage environment / conditions are conducive and the people who handle are aware and are able to manage, you are good.
Is there good identification method and is there a risk of a mix up ? This is for you to decide based on your own risk assessment.
However some customs regulations require outgoing area / incoming area to be having seperate holding locations (Bonded warehouse) that are to be kept in locked conditions, which you may have to consider if applicable.
 
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