Changing Non-Critical Component Suppliers - Convenience kits (FDA) Procedure packs

Gumaer

Starting to get Involved
#1
My company assembles convenience kits (FDA) / procedure packs (MDD). If the customer specification simply says 4.5 oz PP cup (used for urine collection), would changing the supplier of the cup (like for like) be considered a specification change?
 

MIREGMGR

Inactive Registered Visitor
#2
Re: Changing Non-Critical Component Suppliers - Convenience kits (FDA) Procedure pack

If the spec is that vague, you probably erred in accepting the PO without clarification.

Who called out the original (at time of PO) vendors?

If the customer, the vendor selections are an implied spec as well.

If the PO does not explicitly include in its definition of your directed actions the determination of vendors and the determination of whether alternate components are in fact "like-for-like", you are in the position of having to get the customer's approval for any vendor change or component substitution.

Contract review is all-important in avoiding questions like this.
 
T

taha3000

#3
Re: Changing Non-Critical Component Suppliers - Convenience kits (FDA) Procedure pack

Dear Colleague

what are the FDA guidance for convience kit or procedure packs.


regards


Taha
 

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