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ASQ Certified Pharmaceutical GMP Professional Sample Questions:

1. Development criteria for in-process inspections should include:
Response:

A) Color preference surveys
B) Seal tests
C) Marketing feedback loops
D) Packaging aesthetics

2. Analytical laboratory site change requires careful __________ of results between sites.
Response:

A) disregard
B) comparison
C) marketing
D) lowering

3. Which qualifications ensure that facilities, equipment, and utilities perform correctly under their operational range before being used in a manufacturing process?
(Choose two)
Response:

A) Installation Qualification (IQ)
B) Initial Qualification (IQ)
C) Performance Qualification (PQ)
D) Environmental Qualification (EQ)

4. Which of the following statements is true about marketing requirements and compendia?
Response:

A) Marketing authorization in Europe requires compliance with the JP.
B) The EP is a requirement for marketing authorization within European countries.
C) The USP is the only compendium recognized worldwide.
D) Marketing authorization in Japan does not require compliance with any pharmacopoeia.

5. The Japanese Pharmacopoeia (JP) is primarily required for marketing authorization in:
Response:

A) All countries worldwide
B) Japan
C) The United States
D) Europe

Solutions: