MJ_Connors
Registered
Hi,
Long time lurker.
The issue at hand is a contract manufacturer used by my organization currently makes the "device" in a drug-device combo product. They have now come to us and stated they would like to expand activities to include the "drug" part as well. This would include, among other things, the creation of the drug-excipient solution, application to the device, pre-sterile testing and primary packaging. This is not a small amount of effort.
I have told them they would need to revise their current ISO 13485:2016 cert scope to include the drug application part (beyond the existing "manufacture of <X TYPE> of medical devices" yadda yadda). Naturally, they push back and say that would be too much work (as if the rest of the process of transferring a drug application technology *isn't* work?).
Our notified body (not the CM's) is notably strict on these topics, and will most definitely pay them a visit as part of the critical supplier audit. I see a deviation coming when their ISO scope does not include this incredibly high-risk activity.
They respond that their NB (a notably soft one) has advised them it's not necessary.
My question to the minds here: How specific would you get in the scope of activities here, especially in a high-risk situation?
p.s. the more I write this out, the more clear it seems to me, but maybe that's my problem?
Long time lurker.
The issue at hand is a contract manufacturer used by my organization currently makes the "device" in a drug-device combo product. They have now come to us and stated they would like to expand activities to include the "drug" part as well. This would include, among other things, the creation of the drug-excipient solution, application to the device, pre-sterile testing and primary packaging. This is not a small amount of effort.
I have told them they would need to revise their current ISO 13485:2016 cert scope to include the drug application part (beyond the existing "manufacture of <X TYPE> of medical devices" yadda yadda). Naturally, they push back and say that would be too much work (as if the rest of the process of transferring a drug application technology *isn't* work?).
Our notified body (not the CM's) is notably strict on these topics, and will most definitely pay them a visit as part of the critical supplier audit. I see a deviation coming when their ISO scope does not include this incredibly high-risk activity.
They respond that their NB (a notably soft one) has advised them it's not necessary.
My question to the minds here: How specific would you get in the scope of activities here, especially in a high-risk situation?
p.s. the more I write this out, the more clear it seems to me, but maybe that's my problem?