To follow up on my previous question about design control requirements for drug-device combinations for ophthalmic vial (Class 1 device) that was approved as a drug.
We are looking to develop design history file for the an approved, marketed product. We are thinking to leverage the product development reports and documents from 32P of the NDA. What are your thoughts on this approach? What gaps are there between 32P and required docs for Class 1 device design history file. We can also leverage the process validation documents. What about PQ documents? We are working to compile the document package and not reinvent the wheel for an approved product already in commercial production.
Nothing wrong with your approach. A little "reverse engineering" / retrospective compilation. Not the most desirable to the FDA as it defeats some of the purpose of Design Control, i.e., affecting the initial design process to produce a safer device. Your approach is certainly appropriate as some of the the Combo / NDA information would have come from the DHF had such been developed first. It's similiar to the approach I would take in compiling a DHF after the fact. In a combo product per 21 CFR 4, if the drug is the higher risk component, your CGMP "operating system" is 21 CFR 210, -211, with 21 CFR 820.30, Design Control, to be added for the device component. Design control is focused on the device component, and the effects of any drug-device interactions primarily.
Device design V&V (Verification and Validation) can also be compiled retroactively (again the least desirable to the FDA, vs concurent and prospective (most desirable)), but acceptable. the IQ/OQ/PQs are for the production / test equipment and software. Your device design V&V should focus on the Device / Combo Requirements / "User" Needs, as per the slide on Product Verification / Testing Examples slide, e.g., biocompatibility, functionality, sterility, etc., and consideration of the drug / device interaction, e.g., leachables, also system biocompatibility, stabiltiy, shelf life, packaging/shake and drop/cross country shipping and similar. Each one of these verifications would generally be a lab test report, and put all together, would make up the device validation.
Wherever possible, by all means, use already developed material, and merely fill in the gaps to complete the DHF. Include a description of what was done and why in your cover narrative in the DHF. Don't forget reference to a Risk Management File (ISO 14971; mandatory) and maybe a Use / Human Factors Engineering File (IEC 62366-1; possibly if your device has some not too famiIiar use interface features). I have not seen any problem with this approach in my personal experience with both the FDA and N-B inspectors.
-- jel@jelincoln.com
No comments:
Post a Comment