Compiling the DHF Q&A:

I attended the Effective Design Control (21 CFR Part 820.30) webinar on 01Feb2023 and found the information presented to be very useful. Thank you for the invite to send follow-up questions.

Our company divides product development into 5 phases: Product Initiation, Feasibility, Optimization, Validation & Transfer, and Launch. Each of these phases has a checklist of actions and deliverables applicable for the phase. We consider these checklists, our Design Plan. One of my goals this year is to streamline the DHF compilation process. My email to you is to confirm that I am interpreting the following 2 points correctly:

1) I liked what you said on slide 10, "Not all of the records generated during the project are design outputs and as such do not need to be retained in the Design History File", that only the outputs need to be retained. For example: No, the email from Finance noting what the pricing should be for the product does NOT need to be retained in the DHF or Supply Agreements.

My Answer:

That's correct per FDA requirements.  I did say that key interim inputs / outputs should be captured under either the DI or DO DHF "file" tabs. Your company should define what are "key" to show the path from initial DI to final DO, and the SOP should state where (under which heading) those interim DI/DO's should be placed.  And I mentioned that the DHF can serve a valuable additon to your company's IP, so that's also a consideration as to any supplemental information you'd also want to include beyond the CGMP minimums.

2) Currently, our checklists note the date the action/deliverable was completed. I noticed on slide 6 that adding the completion dates for each individual activity is not necessary. This makes sense to me because the date that the phase review takes place IS recorded in the meeting minutes for the phase review and those are all retained in the DHF. 

My answer:

Again true.  However having a record of start and completion dates for each Milestone / Task / Deliverable may be of use to your company in providing a more accurate time frame for future similar activities than a "guestimate" and may be desirable to retain for that reason.  However, if the key dates are addressed in the Review minutes for each phase / milestone/task which should be retained in the DHF also, there's no need for redundancy.  As a project leader on these type of projects, I usually liked to keep such information on my Gantt Charts, which charts were then added to the DHF, usually in the beginning of the File, under Plan.

-- jel@jelincoln.com