Shared Responsibility Between Spec Provider and Contract Manufacturer

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wenrw

Hello all,

I am new to the forum and after several hours reviewing information here, decided to explicitly ask about some of the questions I had as I was still unclear about the answer.

My background is in Design and Development Engineering however I am currently working business development for a very small med device startup. Although I have seen a lot of the QS/cGMP at larger medical device companies, I have never been directly involved with their implementation.

We have already launched one successful product (which I was not involved with) and are in the development process with two more. I am tasked with the development of these 2 other products. Both products are very simple Class I devices that will be manufactured, packaged, sterilized, tested, and shipped to us by a contract manufacturer. We will be providing them with all of the specifications on the devices. Unfortunately, neither product will be exempt from GMP. All that our company will be doing is storing, marketing, selling, and delivering the final product delivered from the CM. Obviously this comes with servicing complaints as well.

If I am not mistaken, we would be the "specification developers" for the product, which requires us to maintain cGMP. Because of this, are we responsible for putting extensive quality systems in place that involve the manufacturing of the device or can some of this be passed off to the CM? I see us being involved in the distribution and complaint/servicing part of the QSR, but it seems that most of the manufacturing quality would be taking place with our CM. Are we able to pass off some of the quality systems to the CM or are we responsible for the entire thing?

As you can imagine, developing an entire QS as such a small company would introduce a huge strain onto our company. While I think I am capable of doing this, I would anticipate this taking over a year of work that would take a large amount of my time. Are there any ways to get out of developing a complete QS that includes all of the manufacturing as well?

Thank you in advance for any guidance you guys can provide on the topic!
 
M

MIREGMGR

...we would be the "specification developers" for the product, which requires us to maintain cGMP.

Yes.

Because of this, are we responsible for putting extensive quality systems in place that involve the manufacturing of the device or can some of this be passed off to the CM? I see us being involved in the distribution and complaint/servicing part of the QSR, but it seems that most of the manufacturing quality would be taking place with our CM. Are we able to pass off some of the quality systems to the CM or are we responsible for the entire thing?

You have full primary responsibility. You can contract with the CM to do additional things for you, but you cannot shift responsibility to them.

Note however that, if the CM is itself a Registered Establishment, FDA will regard them as additionally responsible because they're supposed to know the rules. There is precedent for this in Warning Letters. This however does not remove any responsibility from you.

Are there any ways to get out of developing a complete QS that includes all of the manufacturing as well?

Sure. Have the product "belong" to someone else, and just be a distributor under the Private Labeling rules.

That's it. There's no other way.
 

Ronen E

Problem Solver
Moderator
That's it. There's no other way.

While technically true, it is a bit of a harsh way of putting it, IMO. As a general guideline, Spec Dev's are required, under the QSR, to have documented procedures for processes and activities that they carry out, plus a few that are mandatory for all manufacturers (complaint files etc.). My reference is (the late) FDA Quality Systems Manual guide and part 820 itself.

It's true that essentially the Spec Dev, as the entity under whose name (and responsibility) the device is put into distribution, has primary regulatory responsibility (not withstanding the precedent mentioned and consequent general FDA approach); however this can be realized in part by the CM and controlled (hi-level) through the manufacturing contract. So, the relevant parts of the SD's QMS can be very lean, referring to the contract, the CM's QMS etc.

Cheers,
Ronen.
 
W

wenrw

Thank you for your help guys! That was what it seemed the case was so now we've got some decisions to make.
 
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