Additional specific rating:

Priority Major Minor Not Applicable

No program is in place AND a product has been
subject to regulatory action.
Remote Verification Acceptable:
The responsibility could be shared corporate, See finding severity definition Not applicable
and the facility then complete the relevant
section 1 and/or 2
a. If the implementation is done at a
corporate level, then verify 1), if not
complete then “Major”
b. if the implementation at the facility level,
then verify 2)
c. If the implementation at both levels, then
verify 1) and 2), then the highest of both
ratings apply
Yes

Page 139 of 146

VAP Operations Manual V8.0
Auditor Only Version