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ASQ Certified Pharmaceutical GMP Professional Sample Questions:

1. Updating specifications is crucial when:
Response:

A) There is a change in the source of raw materials
B) New employees are hired in the laboratory
C) Compendial references are updated
D) There is a slight variation in test results

2. A comprehensive pest control program in a pharmaceutical facility should include:
(Choose two)
Response:

A) Use of appropriate traps for pest elimination
B) Deployment of pets for natural pest control
C) Installation of decorative traps
D) Use of authorized rodenticides and insecticides

3. Qualification of packaging equipment ensures the equipment is:
Response:

A) The latest model available
B) Available in surplus
C) Maintained and functional
D) Least expensive

4. The ICH is an organization that harmonizes regulations across different regions. What does ICH stand for?
Response:

A) International Coalition for Harmonization
B) International Center for Health
C) International Conference on Harmonization
D) International Council on Healthcare

5. The impact analysis for a proposed change should NOT:
Response:

A) Be limited to immediate effects
B) Exclude input from external consultants
C) Ignore potential impacts on regulatory compliance
D) Consider only the positive outcomes

Solutions: