RAC Test 2: Exam Questions and Answers with Verified Solutions |
Latest 2026 Update
Q: Requirements for Reserve Lots of API
Answer:
A reserve sample representative of each lot of each shipment of each active
ingredient shall be retained.
2x the amount that would be needed for the testing protocol are needed Reserve
samples need to be stored at labeled conditions
Any deterioration needs to be investigated
Q: Special Control
Answer:
Black Box Warning
Q: Treatement IND
Answer:
issued as a means of providing eligible subjects with investigational drugs or
biologics for the treatment of serious and life-threatening illnesses for which there
are no suitable alternative treatments. Regulatory Reference: 21 CFR Part 312.83.
Q: Auditor Independence
Answer:
The quality assurance manager cannot audit areas of the quality system for which
he/she is responsible. Regulatory Reference: 21 CFR 820.22.
Q: ANDA cannt be expidited because:
Answer:
Products that show evidence of safety and effectiveness in a new subpopulation
Q: Orphan Drug Status
Answer:
cannot be requuested once another NDA (non-orphan) is under reivew for the same
indication.
Q: HDE Device Application
Latest 2026 Update
Q: Requirements for Reserve Lots of API
Answer:
A reserve sample representative of each lot of each shipment of each active
ingredient shall be retained.
2x the amount that would be needed for the testing protocol are needed Reserve
samples need to be stored at labeled conditions
Any deterioration needs to be investigated
Q: Special Control
Answer:
Black Box Warning
Q: Treatement IND
Answer:
issued as a means of providing eligible subjects with investigational drugs or
biologics for the treatment of serious and life-threatening illnesses for which there
are no suitable alternative treatments. Regulatory Reference: 21 CFR Part 312.83.
Q: Auditor Independence
Answer:
The quality assurance manager cannot audit areas of the quality system for which
he/she is responsible. Regulatory Reference: 21 CFR 820.22.
Q: ANDA cannt be expidited because:
Answer:
Products that show evidence of safety and effectiveness in a new subpopulation
Q: Orphan Drug Status
Answer:
cannot be requuested once another NDA (non-orphan) is under reivew for the same
indication.
Q: HDE Device Application
