RAC-DRUGS FINAL EXAM 2025
QUESTIONS AND DETAILED CORRECT
ANSWERS | A+ GRADE VERIFIED
ANSWERS
A company's supplier of the active drug substance for the
company's OTC drug product informs the company that
the supplier will be moving their production of the drug
substance from the current plant to a new manufacturing
plant in another state in 6 months. The supplier states that
all manufacturing processes will remain the same and the
specifications will not change. The company intends to
qualify the change suitably. How should the company
report the change to FDA?
A. The change only needs to be reported in an annual
report because the company will qualify the change and
the supplier said the process and specification won't
change
B. The change should be reported in a pre-approval
supplement (e.g., CBE, CBE-30 or full pre-approval
supplement) because it is a change to the drug substance
manufacturing location
C. The change does not have to be reported because it is
an OTC drug
D. Not enough information Correct Answer D. Not enough
information
,Which of the following is exempt from GMP/QSR
regulations?
A. Remanufacturers
B. Custom device manufacturers
C. Repackagers
D. Component manufacturers Correct Answer D.
Component manufacturers
Component manufacturers are excluded from GMP per 21
CFR 820.1(a)(1).
All of the following are considered General Controls under
the Food, Drug & Cosmetic Act EXCEPT:
A. Establishment registration
B. Premarket approval application
C. Medical device reporting
D. Listing of the device Correct Answer B. Premarket
approval application
Premarket approval application (PMA) is not a general
control.
According to the Quality System Regulation, suitable
maintenance of equipment is necessary to ensure that
manufacturing specifications are met. All of the following
are requirements for the equipment EXCEPT:
A. A written maintenance schedule is required
,B. Allowable tolerances are posted on or near the
equipment
C. Maintenance must be performed at least annually
D. Inspections of equipment must be documented Correct
Answer C. Maintenance must be performed at least
annually
QSR does not specify "annually":
Maintenance schedule. Each manufacturer shall establish
and maintain schedules for the adjustment, cleaning, and
other maintenance of equipment to ensure that
manufacturing specifications are met. maintenance
activities, including the date and individual(s) performing
the maintenance activities, shall be documented.
According to the QSR, Quality Audits must accomplish the
following:
A) Meet the same requirements of the original GMP
B) Evaluate if the Quality System is in compliance with the
QSR
C) Determine the effectiveness of the Quality System
D) Focus on Design Controls and the CAPA system
E) B and C above
F) A and D above Correct Answer E) B and C above
B) Evaluate if the Quality System is in compliance with the
QSR
C) Determine the effectiveness of the
, Each manufacturer shall establish procedure for quality
audits and conduct such audits to assure that the QS is in
compliance with the established QS requirements and to
determine the effectiveness of the QS.
Quality System
FDA investigators may review the schedule for your
internal audits but are not supposed to ask to see the audit
results
From the QSIT Manual:
Review the firm's quality audit schedules to assure quality
audits are being conducted with sufficient frequency. It is
recommended that the time between quality audits not
exceed a 12-month period. More frequent audits may be
recommended if the firm has a serious Quality System
Regulation problem. Evidence of inadequate auditing may
exist without gaining access to the written quality audit
reports.
The MDR regulations require that which of the following
groups are not required to notify FDA if they become
aware of information required to be reported.
A) Manufacturers
B) Distributors
C) Initial importers
D) User facilities Correct Answer B) Distributors
Distributors are not required to report to FDA
QUESTIONS AND DETAILED CORRECT
ANSWERS | A+ GRADE VERIFIED
ANSWERS
A company's supplier of the active drug substance for the
company's OTC drug product informs the company that
the supplier will be moving their production of the drug
substance from the current plant to a new manufacturing
plant in another state in 6 months. The supplier states that
all manufacturing processes will remain the same and the
specifications will not change. The company intends to
qualify the change suitably. How should the company
report the change to FDA?
A. The change only needs to be reported in an annual
report because the company will qualify the change and
the supplier said the process and specification won't
change
B. The change should be reported in a pre-approval
supplement (e.g., CBE, CBE-30 or full pre-approval
supplement) because it is a change to the drug substance
manufacturing location
C. The change does not have to be reported because it is
an OTC drug
D. Not enough information Correct Answer D. Not enough
information
,Which of the following is exempt from GMP/QSR
regulations?
A. Remanufacturers
B. Custom device manufacturers
C. Repackagers
D. Component manufacturers Correct Answer D.
Component manufacturers
Component manufacturers are excluded from GMP per 21
CFR 820.1(a)(1).
All of the following are considered General Controls under
the Food, Drug & Cosmetic Act EXCEPT:
A. Establishment registration
B. Premarket approval application
C. Medical device reporting
D. Listing of the device Correct Answer B. Premarket
approval application
Premarket approval application (PMA) is not a general
control.
According to the Quality System Regulation, suitable
maintenance of equipment is necessary to ensure that
manufacturing specifications are met. All of the following
are requirements for the equipment EXCEPT:
A. A written maintenance schedule is required
,B. Allowable tolerances are posted on or near the
equipment
C. Maintenance must be performed at least annually
D. Inspections of equipment must be documented Correct
Answer C. Maintenance must be performed at least
annually
QSR does not specify "annually":
Maintenance schedule. Each manufacturer shall establish
and maintain schedules for the adjustment, cleaning, and
other maintenance of equipment to ensure that
manufacturing specifications are met. maintenance
activities, including the date and individual(s) performing
the maintenance activities, shall be documented.
According to the QSR, Quality Audits must accomplish the
following:
A) Meet the same requirements of the original GMP
B) Evaluate if the Quality System is in compliance with the
QSR
C) Determine the effectiveness of the Quality System
D) Focus on Design Controls and the CAPA system
E) B and C above
F) A and D above Correct Answer E) B and C above
B) Evaluate if the Quality System is in compliance with the
QSR
C) Determine the effectiveness of the
, Each manufacturer shall establish procedure for quality
audits and conduct such audits to assure that the QS is in
compliance with the established QS requirements and to
determine the effectiveness of the QS.
Quality System
FDA investigators may review the schedule for your
internal audits but are not supposed to ask to see the audit
results
From the QSIT Manual:
Review the firm's quality audit schedules to assure quality
audits are being conducted with sufficient frequency. It is
recommended that the time between quality audits not
exceed a 12-month period. More frequent audits may be
recommended if the firm has a serious Quality System
Regulation problem. Evidence of inadequate auditing may
exist without gaining access to the written quality audit
reports.
The MDR regulations require that which of the following
groups are not required to notify FDA if they become
aware of information required to be reported.
A) Manufacturers
B) Distributors
C) Initial importers
D) User facilities Correct Answer B) Distributors
Distributors are not required to report to FDA
