Hi my dear covers..
I seek your advise regarding the maintainance of DHF.
we have a project to launch one product in US, we got FDA clearance.
Now, we would like to expand the scope of the project to launch in EU..and would like to maintain the DHF..so now, some new tests are done for EU launch,hence extra docs came in..
so the question is, do we need to maintain a separate DHF with separate part number, in which some docs will be upgraded with revisions, a few will be overlapped.
Or, same DHF with revision upgrade?
In this case, if FDA comes to audit (may be over a period of time(, then some addition docs are appended in DHF which are not required for QSR, wil it be a problem?
Waiting to get your thoughts.
Thanks,
Sreenu
I seek your advise regarding the maintainance of DHF.
we have a project to launch one product in US, we got FDA clearance.
Now, we would like to expand the scope of the project to launch in EU..and would like to maintain the DHF..so now, some new tests are done for EU launch,hence extra docs came in..
so the question is, do we need to maintain a separate DHF with separate part number, in which some docs will be upgraded with revisions, a few will be overlapped.
Or, same DHF with revision upgrade?
In this case, if FDA comes to audit (may be over a period of time(, then some addition docs are appended in DHF which are not required for QSR, wil it be a problem?
Waiting to get your thoughts.
Thanks,
Sreenu
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