My response to a query from one of the participant attended my webinar “Design History Files (DHF), Device Master Records (DMR), Device History Records (DHR), Technical Documentation Files”. 

 Query : Thank you for this webinar – I definitely learned a few things. I had asked a question about whether a full PV on the fully scaled up manufacturing process was required for EU MDR submission – and you indicated yes.  We have also had that interpretation from at least one other person.

Ans:  My answer was more geared to the FDA. For EU MDR, double check with your Notified-Body.  But things can happen from pilot to scale up, hence my answer.

Also my comments on "Like For Like" -- isn't!  There's always subtle differences in so-called "identical" equipment / processes, which must be addressed in a verification or validation, albeit perhaps in a reduced format, depending upon user / patient risk, and or nature of the potential variance. 

Ques: I was just thinking that through and am wondering if that means we need to expand the scope of our Design Inputs to include the stages of Process Transfer and Validation?

We use a DIOVV Matrix – Design Inputs, outputs, verification, and validation – and start with a stakeholder need that then translates in to one or more design inputs.  And of course then the design outputs, verification documents, and validation documents as appropriate for each design input get listed.

Just wondering if we need to add a section to the DIOVV so that we address Process Transfer and Validation?  Would you consider those things as legitimate Design Inputs??

Design inputs really are very tricky things – we spend a lot of time debating them.

 Ans:  Agreed. As I mentioned in the webinar, the definitions of DI and DO elicit strong opinions, and when I meet with clients on Design Control, we spend the majority of a session just on those two elements of the 10 in Design Control.

Bottom line as mentioned in the webinar:  You as a company define what will be a DI and a DO, as DI’s become Interim DO’s become interim DI’s, ad infinitum. Certainly the initial DI’s would be under the DI category, as would the final DO’s be under the DO category, with the interim DI’s and DO’s being placed where they are easiest to understand per your company’s methods / definitions, as spelled out in your SOPs.   

https://www.fda.gov/media/116573/download  

Notice last para (2^nd half), pg 3, Concurrent engineering pg 5, discussion on DI and DO, pp. 13-21, note especially the root problem on the top of page 20 “The design output in one stage is often part of the design input in subsequent stages.”

... and Design Transfer per 820.30 is a separate / discrete step / milestone in the R&D project subject to Design Control, i.e., one destined to commercialization (see below).

Ques: It’s potentially an interesting paradigm shift because typically R&D ‘owns’ the DIOVV – we do Process Transfer – and Operations executes the final PV(s) – and so this would mean engaging Operations earlier in the Development Process, which might be a good thing.

Ans:  Under Design Control, Design Transfer is a formal discrete activity.  But per Concurrent Engineering in the above referenced Guidance documents, it goes easier if all stakeholders are involved in the project from the very beginning as mentioned in the webinar, and the “good thing” you mentioned above – I would expand the early participants to more than operations, including manufacturing / production, manufacturing engineering and QA/QC and RA and others. I practiced that with new product development in the 1980’s to great effect with minimal “surprises” and meeting schedule.

-- John E. Lincoln

jel@jelincoln.com