Design Controls for Combination Drug Product Manufacturer (ANDA)

[v9991]

We intend to manufacture drug device combination product; ( basically assembling of the product is what is done at our facility; very-roughly, drug solution is filled into a component and capped )

• design of the product is look-alike to that of innovator. ( device design to be same as that of innovator, reference listed, FDA-approved product);

• There are specific criteria for drug product performance which will be demonstrated (verified & validated)

Now my question is about the details covered in 820.30 Design Controls
option -1 :- not relevant for our manufacturing facility ( Design controls established at component-suppliers is adequate)
option -2 :- design controls of individual components (referenced to respective suppliers-documentation) and the controls for assembling process to be maintained.
Option -3 :- design controls for assembling process to be maintained. ( individual components would be directly filed with FDA and only a reference document Number is cited)

 

[v9991]

with some persistent and detailed searching, got the clarification,

ANSWER :- it is relevant and required to "

to ensure appropriate selection of constituent parts and appropriate evaluation of their interactions and interrelationships

"
Webinar @ FDA on combination product.
https://collaboration.fda.gov/p83277278/?launcher=false&fcsContent=true&pbMode=normal

ref. Ref.comments cntd section.

 

[Marc]

Thanks for coming back and letting us know what you found out. Sorry no one here could help.