Moving from Contract Manufacturing to Production In-House

[Ed Panek]

We use an ISO 13485:2016 manufacturing house to make our med device. Its a class 2 FDA 510 cleared and CE marked. We do not offer service or installation on our scope

We are adding production. Is there a good checklist of objectives to allow me to communicate to our BoD what this change entails for QA/RA?

Thanks in Advance,

Ed

 

[Ronen E]

Maybe that's a starting point (not a checklist):
https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm467414.pdf

Other than that, I remember we had a lot of discussions at the Cove, over the years, about moving manufacturing sites or establishing new ones. Should be some useful content there, I just don't have time to fish it out.

 

[somashekar]

We use an ISO 13485:2016 manufacturing house to make our med device. Its a class 2 FDA 510 cleared and CE marked. We do not offer service or installation on our scope

We are adding production. Is there a good checklist of objectives to allow me to communicate to our BoD what this change entails for QA/RA?

Thanks in Advance,

Ed

You are adding production. To this extent about the QA, what you need to tell BoD are perhaps...

1. Provision of resources including human resources, skill competency and authorities defining​

2. Required infrastructure​

3. Required work environment​

4. Validation of processes​

5. Cleanliness of the product per requirement​

6. Identification and trace-ability requirement​

7. Control of Non conforming products​

8. Rework controls​

9. Control of records​

10. Control of monitoring and measuring equipment​

You are adding production. To this extent about the RA, what you need to tell BoD are perhaps...

1. Communicating the significant changes to your CB/NB, with plan of change implementation​

2. Review your FDA device listing if you need to make any changes there in the listing​

3. Review and make changes to your CM agreement or cancel of the same with an effective date​

4. Capturing the last Sl # / Lot # of devices manufactured at your CM house​

 

[Lokus200]

Consider it as transfer manufacturing to a different contractor, where the different contractor is you.