QMS requirements for legal manufacturer when outsourcing manufacturing process

#1
Hi guys,

I was wondering if someone can help me....If I'm the legal manufacturer of a medical device and I outsource the manufacturing process, what parts of the quality system requirements do I have to comply as per MDR 2017/745 and FDA?
Thank you.
 
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Marcelo

Inactive Registered Visitor
#2
Hello, and welcome to the Cove. If you are the "legal manufacturer" (please note that this term do not exist in all regulatory systems), you are responsible for complying with all the regulatory requirements, including the QMS requirements. If you outsource some aspects, you need to control them in YOUR qMS, but you must make it clear who performs them in your name (this is done thru a quality agreement, see this FDA guidance (chichis for drugs but the idea is the same for devices) - Contract Manufacturing Arrangements for Drugs: Quality Agreements.
 
#3
Hi Marcelo,

Obrigada :) Was very helpful...

It means that i don't have to have in my QMS the procedures that my contractor manufacturer has (manufacturing procedures for example) in their QMS? I just have to control and make sure they (with their procedures) are compliant with QMS requirements?

For example: do I need device history record (batch/lot control) in my QMS or I can just use/control the contractor's records? Because as a legal responsible I have to track the devices specially for post market surveillance purposes.

Obrigada again.
 

racglobal

Involved In Discussions
#4
Hi Gisah,

As the legal manufacturer (your name on the label), you are responsible for the manufacturing part of your QMS even if it is outsourced. I would still recommend having manufacturing procedures in place to ensure the overall process is clear. You do not need your device history records, but your CMO should allow you access to the DHRs at your request. Again, this has to be made very clear in a quality agreement. If anyone has additional insights, I would also like to hear.
 

Ronen E

Problem Solver
Staff member
Moderator
#5
Hi Gisah,

As the legal manufacturer (your name on the label), you are responsible for the manufacturing part of your QMS even if it is outsourced. I would still recommend having manufacturing procedures in place to ensure the overall process is clear. You do not need your device history records, but your CMO should allow you access to the DHRs at your request. Again, this has to be made very clear in a quality agreement. If anyone has additional insights, I would also like to hear.
I would say the other way around. They don't need manufacturing procedures for operations they don't perform and don't have expertise in anyway. On the other hand, I would try hard to reach agreement that they get a full copy of each DHR with the supplied corresponding batch. Only if they hit resistance I would go for an access agreement instead, and that only as a last resort (if proprietary info is involved maybe negotiate redacting or partial supply of the DHR). The time they might need the DHR the most might prove to be a time that the CM would be least cooperative, because there might be a conflict of interest in some cases.
 
#6
I would say the other way around. They don't need manufacturing procedures for operations they don't perform and don't have expertise in anyway. On the other hand, I would try hard to reach agreement that they get a full copy of each DHR with the supplied corresponding batch. Only if they hit resistance I would go for an access agreement instead, and that only as a last resort (if proprietary info is involved maybe negotiate redacting or partial supply of the DHR). The time they might need the DHR the most might prove to be a time that the CM would be least cooperative, because there might be a conflict of interest in some cases.
Hi Ronen,

Thank you. I agree with you about the manufacturing procedures and DHR...it makes more sense.
 

Watchcat

Trusted Information Resource
#7
If you are the "legal manufacturer" (please note that this term do not exist in all regulatory systems), you are responsible for complying with all the regulatory requirements, including the QMS requirements. If you outsource some aspects, you need to control them
They don't need manufacturing procedures for operations they don't perform and don't have expertise in anyway.
I may be answering this one with my MBA hat on more than my RA hat. I would agree that you are responsible for your product, and not just for its compliance with regulatory requirements. I don't see how you can fulfill that responsibility if you don't understand its manufacture.

[As an aside for clarification, "The process is the product." I work mostly on the premarket side, where I find developers often think their design is the product. A design is just a good idea. V&V done right, confirms that the design is a good idea. The product is an output of the manufacturing process, and it is that process that defines what the product is. When products fail at scale up, it often turns out that the development team didn't include manufacturing expertise.]

I think contract manufacturing makes good business sense from the perspective of not having to make a huge investment in capital equipment and labor. It is essentially a means of achieving economies of scale. I think outsourcing expertise is quite a different matter.
 

Ronen E

Problem Solver
Staff member
Moderator
#8
I don't see how you can fulfill that responsibility if you don't understand its manufacture.
In this context, understand is a parameter - there are infinite degrees possible between full understanding (expertise) and no understanding at all. IMO one can be perfectly responsible for their product with a good understanding at some medium detail-level; it's not necessary to master all the nitty gritty.
V&V done right, confirms that the design is a good idea.
This is a great example why the term "V&V" annoys me so much. The second V typically stands for Validation, and here it apparently refers to Design Validation. While the latter is a very common term, fairly-well understood in the industry, it makes little sense if you look at what it actually means. One can't really validate a pure design (which is an abstract object; drawings are not the design, they're just a medium to convey it). To "validate a design" (in the sense regulators intend, and industry typically applies) you need a physical product, one that users can use. So a much more accurate term would be Product Validation (in contrast with Process Validation, which is a different beast).

In that sense Design Validation, or Product Validation, can't be completed without some fairly-good understanding of the manufacturing process, and especially it's parameters, noises and limitations, but the step where a very intimate knowledge of the manufacturing processes is required is actually Process Validation. Luckily, Process Validation can usually be scoped as a turn-key and outsourced to a Contract Manufacturer. Again, it doesn't mean one should shut their eyes and minds to it - it's always better to have some understanding, involvement and critical thinking even if one doesn't have the expertise; but it's usually unnecessary (and maybe even damaging) to control every little detail in this activity (where outsourced).
When products fail at scale up, it often turns out that the development team didn't include manufacturing expertise.
I tend to agree, and we have a name for it - DFM (Design For Manufacturability). But that should come quite before one even starts to develop the manufacturing process in any detail. It's an essential part of product design, not something external to it. When design engineers fail at that (and they do, quite a lot, sadly), it is a design failure first and foremost. The level of expertise that a CM typically has, the one that IMO the Specification Developer doesn't need to have, is at much finer levels of detail. It can, and usually should, be incorporated into the product realization process, but it can happen in later stages.
I think contract manufacturing makes good business sense from the perspective of not having to make a huge investment in capital equipment and labor. It is essentially a means of achieving economies of scale. I think outsourcing expertise is quite a different matter.
I think you might have written this wearing your Class III devices hat. When considering lower-risk device types, outsourcing manufacturing (Private Labeling) is, not in a few cases, a way to gain access to technical expertise while focusing on core strengths such as marketing. I'm nothing near a business expert, but it seems to me that it works all right, at least in some of the cases.
 

Watchcat

Trusted Information Resource
#10
This is a great example why the term "V&V" annoys me so much. The second V typically stands for Validation, and here it apparently refers to Design Validation. While the latter is a very common term, fairly-well understood in the industry, it makes little sense if you look at what it actually means. One can't really validate a pure design (which is an abstract object; drawings are not the design, they're just a medium to convey it). To "validate a design" (in the sense regulators intend, and industry typically applies) you need a physical product, one that users can use. So a much more accurate term would be Product Validation (in contrast with Process Validation, which is a different beast).

In that sense Design Validation, or Product Validation, can't be completed without some fairly-good understanding of the manufacturing process
While I like "V&V" 'cause its catchy. :p

I see where you are coming from, but on this I think I'll stand my ground. You make physical devices that meet the design requirements, you use them to validate the design (essentially that you CAN make a physical device that meets the design requirements AND the user requirements). So it really is a good idea! But it's not a product until you can reliably manufacture more devices that also meet requirements.

Maybe more my startup hat, as they love to do V&V with prototypes that they have no idea how to manufachave for market. Im not always opposed to this, but it tends to make them think they are done, when they are not, and still don't know if their good idea will ever be a marketable product.
 
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