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ASQ Certified Pharmaceutical GMP Professional Sample Questions:

1. ICH Q9 focuses on:

A) Risk management
B) Analytical validation
C) Stability requirements
D) Clinical trials

2. Which stock rotation methods are used to minimize the risk of using expired or outdated materials?
(Choose two)
Response:

A) First-expired/first-out (FEFO)
B) Last-in/first-out (LIFO)
C) First-in/first-out (FIFO)
D) Most-expensive/first-out (MEFO)

3. Which of the following is a potential source of contamination in a pharmaceutical manufacturing environment?
Response:

A) Final product testing
B) Air handling systems
C) Properly cleaned equipment
D) Sealed product packaging

4. Clinical trials material must be produced with:
Response:

A) Limited documentation
B) No consideration for packaging
C) The same GMP standards as commercial products
D) Random labeling practices

5. What is a required element in both master and batch records?
Response:

A) Personal employee information
B) Yield calculations
C) Future product development plans
D) Marketing strategies

Solutions: