Traceability and the initiation of GMP Activities

[sbrowning]

Hello everyone,

I think this is a basic question, but my QMS knowledge is still growing so I am not confident I have it correct. I work for a small medical device manufacturer that is establishing their QMS in preparation for their first medical device (small and simple to start). We are working with QSR consultants for establishing the system, but I'm doing much of the legwork writing of procedures, etc.

Some time ago, my employer purchased custom cut Tyvek seals for our thermoformed trays that are ~1 inch to big, which they would like to trim to fit our custom trays (edit to add, with a paper trimmer, not scissors). I've worked in GLP labs before, and I can write procedures, inspection tests, and validation for this (along with associated records for the equipments, maintenance, etc). However, I am not sure this is sufficient--I don't have any experience in a GMP environment. It seems that the thermoformed trays are made to a specification, and we will receive them with a DoC to that spec, but are not GMP. Can we trim the Tyvek seals ourselves?

Thank you for all the advice.

 

[yodon]

Re: When does GMP start (traceable material vs prep manufacturing)?

There are few things going on here.

First, traceability is required only to the extent necessitated by risk. If that material gets out in the field, is there any risk that it would cause harm or fail and need to be recalled?

Second, GMP starting is really when you start any manufacturing activities (arguably when you accept a contract but that's probably cutting too fine for this discussion).

Finally, what's the risk of trimming the seals yourselves? Will that elevate the potential or likelihood of hazards / hazardous situations? (Guessing not). Yes, you should have procedures and all that as you indicated to properly support GMP. I'm guessing the output of this operation can be 100% verified so I doubt validation would be required.

Does that help?

 

[Ronen E]

Re: When does GMP start (traceable material vs prep manufacturing)?

Are these sterile devices? What's the role of the trays and lids?

 

[sbrowning]

Re: Question on Traceability and the initiation of GMP Activities?

Yodon and Ronen, thank you for your replies. Yes, the trays will be EtO sterilized with a single-use disposable medical device inside, although the medical device has not yet been manufactured.

The seals have a 0.5" lip on the tray for heat-sealing, and one identifiable risk is that an improperly sized Tyvek will not seal sufficiently to maintain sterility. The trimmed Tyvek will undergo 100% inspection. The device in tray still has to undergo the EtO sterilization validation, and the trays will undergo burst pressure testing, distribution testing, and aging, and other tests as expected. So although I believe the risk of trimming the seals ourselves is extremely low, the sealed trays will be tested afterwards as well.

"GMP starting is really when you start any manufacturing activities." Isn't trimming the Tyvek ourselves a manufacturing activity? We are not a CMO; we are the manufacturer that will be named on our 510(k) submission. However, we will be using a CMO assembler for the assembly of the device and building the tray, which then will be shipped to the EtO sterilizer.

 

[Ronen E]

Re: Question on Traceability and the initiation of GMP Activities?

You should be validating the design and process you will be using in the long run. There is no point validating a provisional process because you will have to revalidate when you later (soon?) introduce another.

GMP (actually, QSR) applies to all manufacturing steps that lead to finished devices that you'll be placing on the US market.

I wonder what your "QSR consultants" have to say about those issues.

 

[sbrowning]

Re: Question on Traceability and the initiation of GMP Activities?

Thanks, Ronen, I appreciate it. The consultants gave us copies of their procedures/forms/templates and it is up to us (me) to get it as much operational before manufacturing as possible. My employer will bring them back in to evaluate/audit the system before we seek regulatory approval.

 

[Ronen E]

Re: Question on Traceability and the initiation of GMP Activities?

The consultants gave us copies of their procedures/forms/templates and it is up to us (me) to get it as much operational before manufacturing as possible. My employer will bring them back in to evaluate/audit the system before we seek regulatory approval.

Maybe getting a little , but FWIW:

That's a strange approach if you ask me, especially where the responsibility for the actual QMS development is handed to someone not well-versed in medical devices QM practices.

I don't consider handing out canned procedures and forms as "consultation". To add value the consultant would have to help you tailor them to your org and also stick around to support you during break-in and fine-tuning. I think I won't be taking a huge risk speculating that your bosses are trying to save money (consultants time), however you should be aware that this kind of arrangement is not good value for your $. As I already noted, the real value of canned procedures and forms is little and they usually require a lot of shaping before they fit a specific org, plus you could probably get some for free without losing much (or any) of the value; it's just a raw material. Second, I expect that when the consultants come back to audit they will find a lot of NCs and you'll lose much time (and maybe more money) trying to fix them. Perhaps you'll even need a second (hopefully not a third) audit before being ready for official regulatory clearance.

It's like they gave you a cube of wood and a screwdriver, and will be coming back with a gauge that has a round hole in it to see if it passes through.