Hello,

I work in a pharmaceutical company that has acquired a medical device product that we want to produce. I was hoping to get some feedback on a couple of the issues that I’m dealing with in order to make sure that I’m handling the issues appropriately. – We have two components that comprise the product, both of which are being changed. First, we are tightening the specification for a component that is produced by a contract manufacturer. Second, we want to become the manufacturer for the other component.

I believe both of these issues would be considered design changes. As such, the changes would need to be planned out and approved. Then, once the changes are ready to be implemented, they would need to be added to the DHF and DMR. – Am I wrong in my thinking here? Also, would a simple change control request be sufficient to show that the change was planned an agreed to?

I will appreciate any feedback that you have one this.

Thanks!
Jim

Change of manufacturing site is not simple. Sceranios range from "pick up and move", which is just a process change, to involvement of many changes such as design, tooling, testing, and supplier chain. You should analyze your case and take actions accordingly. Of course, don't forget facility registration and listing.

Tightening you specifications also means changing your ITP’s (Inspection & Test Plans). There are so many things you have to consider and as you correctly assumed, you’ll have to start on your design & development process.

Your second component which is to become the manufacturer for other component would be an excellent idea, not only because it mean that you are expanding, but also you’ll have a better control with process involved. Again as treesei had mentioned, there are so many things you need also to consider for expanding your processes.

And “yes”, they have to be added to your DHF & DMR.

A simple change control request would be sufficient as long it is suitable and very effective to your change process. Actually “simplicity” is the best policy - next to suitability and effectiveness.

Goodluck!

Hi treesei & Joshua,

Thanks for the feedback! At least I know that I'm moving in the correct direction. We're still dealing with a lot of confusion at my company regarding the requirements. I come out of some meetings with my head spinning. I feel more confident in how we're handling things now.

Thanks again!
Jim