Storage of finished medical devices per 21 CFR Part 820.150

shimonv

Trusted Information Resource
#1
Hi everyone,
Background: we have a fully operational QMS.

Need: For business reasons, we need to provide a service to another business which consists of a short-term storage for finished medical products, not related to what we do and not intended for the US market. That other business is the legal manufacturer and we don't perform any work or quality related activity. In short, we receive and ship out the product ?as is?; nothing more, nothing less.

Question: Will it be acceptable on FDA inspector if we write a memo explaining and exempting these products from our quality controls? In other words, is it possible to justify ?double standard? by a memorandum?

Thanks in advance!!

Shimonv

P.S. A better alternative would be to update the storage and receiving inspection SOPs to reflect this irregular handling, but frankly there are more important things we would like to do.
 
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Mark Meer

Trusted Information Resource
#2
Re: A challenging question on storage (820.150)

(IMHO...)
I don't think you need to do any action at all. You are essentially just providing a storage service, and it'd be the responsibility of the legal manufacturer to validate you as a storage supplier. Essentially, they should be dictating their own storage requirements to you according to their SOPs of storage and supplier validation.

Possible strict storage requirements aside, just ensure that the storage area is properly segregated/marked-off from your own activities...
 

shimonv

Trusted Information Resource
#5
Thank Mark.
If an auditor looks at purchasing / transaction records and ask "what's this?" or "show me production records for it?" What do I do?
That's were the idea for a memo came from and the question of whether or not FDA auditor would except such a statement, especially when it doesn't concern the US market.
 

Ronen E

Problem Solver
Staff member
Moderator
#6
Thank Mark.
If an auditor looks at purchasing / transaction records and ask "what's this?" or "show me production records for it?" What do I do?
That's were the idea for a memo came from and the question of whether or not FDA auditor would except such a statement, especially when it doesn't concern the US market.
A company is entitled to have multiple business, not all under the jurisdiction of FDA.

The only thing that needs to concern a FDA investigator coming on site is that this bulk of goods doesn't get mixed or otherwise affects your regulated goods. To him/her, it should be considered "part of the environment". As Mark wrote, make sure it is well segregated and marked, and that your normal controls (of all sorts) manage these items well enough to avoid any mix or confusion, and you're good to go.

A memo could not hurt, I guess. It will also show that you devoted 5 minutes to thinking about it (in a way, it's risk management).

Cheers,
Ronen.
 

Kuldeep Singh

Involved In Discussions
#8
Hello everyone,

I go through the 21 CFR 820.150, There is requirement related to proper Stock Rotation, which i consider as FIFO (i.e First in First out) , am i right?

I am confusing for below considerations
1. As our Devices (X-Ray ME Equipments) do not have any shelf life, then how can FIFO applicable to us for Storage area i.e logistic area (where finished good products are placed) ?​
2. FDA asking to facilitate stock rotation for Storage area , Is this requirement applicable for Storage area or we can say Logistic area where we kept finished good products or it also covers the area where we kept the Raw materials (such as components of Medical device i.e SMPS, Relay etc).​
As per my understanding FIFO can only implementable at "RAW Material Storage area".
 

chris1price

Trusted Information Resource
#9
21CFR 820.150 does not specify FIFO, it just says it should be under control. It is up to you to say how you meet the requirement to prevent mix-up, damage, etc. For example, this could be by manufacturing date, serial number or software version.

It talks about needing stock rotation for products that deteriorate over time. It could apply to both incoming or finished materials.
 

Ed Panek

QA RA Small Med Dev Company
Trusted Information Resource
#10
We have two businesses at my company. A 9001 section that is a supplier to our 13485 side. During an audit for 13485 we were asked a question about the 9001 section. I told the auditor that part is subject to 9001 controls and not in the scope of 13485 accreditation.
 
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