RAC Practice Exam 2025|Actual Exam
Test(MULTIPLE CHOICES) and (RATIONALES)
questions and verified answers |GET IT 100%
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Terms in this set (93)
,Which of the following is A.
NOT required for
compliance under 21 CFR
Part 11 (electronic records
and electronic
signatures)?
A Manually generated
timestamped audit trails to
record the date and time
of operator entries and
actions that create, modify
or delete electronic
records.
B Validation of systems to
ensure accuracy
C Authority checks to
ensure that only
authorized personell can
create, modify or delete
electronic records.
D Establishment of and
adherence to written
procedures
The final authority for Institutional Review Board (IRB)
ensuring the adequacy of
an Investigational New
Drug (IND) informed
consent document resides
with the:
,A sponsor wishes to Suitability Petition
obtain permission from
FDA to submit an ANDA
for a drug product that
varies from the Reference
Listed Drug (RLD) in route
of administration, dosage
form, or strength, but
anticipates that the
labeling will be identical
to that of the RLD. What
process should be used to
apply for that permission
from FDA?
A 505(b)(2) NDA is not an New chemical entity when the sponsor has a right of
appropriate regulatory reference to all applicable published studies
submission for the
approval to market a
Distribution records for Name and address of the consignee
drug products must
reference or contain:
, A mid-sized 14 days
pharmaceutical company
negotiated with FDA to
submit a draft Package
Insert (PI) and patient
medication guide
(MedGuide) in annotated
Word format for initial FDA
review, and committed to
submit the Labeling in
Structured Product Label
(SPL) format upon
approval of their product.
What is the preferred
timeline for this
pharmaceutical company
to submit the SPL
formatted labeling upon
product approval?
Adverse event reporting Diagnostic non-invasive test kits
for a marketed biologics
product is NOT required
for:
The quality assurance Auditor independence has not been ensured.
manager of a small
company consisting of 12
employees is the only
internal auditor for the
company and has been
performing all internal
quality system audits for
three years. This does not
meet the requirements for
performing internal quality
systems audits because
Test(MULTIPLE CHOICES) and (RATIONALES)
questions and verified answers |GET IT 100%
ACCURATE!!
Save
Terms in this set (93)
,Which of the following is A.
NOT required for
compliance under 21 CFR
Part 11 (electronic records
and electronic
signatures)?
A Manually generated
timestamped audit trails to
record the date and time
of operator entries and
actions that create, modify
or delete electronic
records.
B Validation of systems to
ensure accuracy
C Authority checks to
ensure that only
authorized personell can
create, modify or delete
electronic records.
D Establishment of and
adherence to written
procedures
The final authority for Institutional Review Board (IRB)
ensuring the adequacy of
an Investigational New
Drug (IND) informed
consent document resides
with the:
,A sponsor wishes to Suitability Petition
obtain permission from
FDA to submit an ANDA
for a drug product that
varies from the Reference
Listed Drug (RLD) in route
of administration, dosage
form, or strength, but
anticipates that the
labeling will be identical
to that of the RLD. What
process should be used to
apply for that permission
from FDA?
A 505(b)(2) NDA is not an New chemical entity when the sponsor has a right of
appropriate regulatory reference to all applicable published studies
submission for the
approval to market a
Distribution records for Name and address of the consignee
drug products must
reference or contain:
, A mid-sized 14 days
pharmaceutical company
negotiated with FDA to
submit a draft Package
Insert (PI) and patient
medication guide
(MedGuide) in annotated
Word format for initial FDA
review, and committed to
submit the Labeling in
Structured Product Label
(SPL) format upon
approval of their product.
What is the preferred
timeline for this
pharmaceutical company
to submit the SPL
formatted labeling upon
product approval?
Adverse event reporting Diagnostic non-invasive test kits
for a marketed biologics
product is NOT required
for:
The quality assurance Auditor independence has not been ensured.
manager of a small
company consisting of 12
employees is the only
internal auditor for the
company and has been
performing all internal
quality system audits for
three years. This does not
meet the requirements for
performing internal quality
systems audits because
