Retention Samples when Customer Leaves

B

BlackHeart

Registered
#1
#1
Hello, Cove.

I’ve searched forums here and the internet but I can’t find an answer.

We are an FDA-registered repackager/relabeler, mostly OTC drugs. We keep retention samples from each batch we run. Our customer is taking the business away from us and will start using a different company.

My question: do we keep the current retention samples, as the “manufacturer", or can they go with the customer to their new facility?

Thanks for any help.
 
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V

v9991

Trusted Information Resource
#2
#2
from QMS point of view, :-
* either way its acceptable. its important to update the respective quality agreement.

few logical thoughts from point of view of agency / regulations , from defining the responsibilities and more importantly , notifying agency suitably.:-
* how is your facility listed/registered in any of the submission documents; ( viz.registration,, labelling etc ) this might require you to retain the retention samples
* how are you delisting your facility from the specific dossier. ( and relevant update to agency ):2cents:
 
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