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ASQ Certified Pharmaceutical GMP Professional Sample Questions:

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

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

2. What is the primary objective of regulatory reporting in the pharmaceutical industry?
Response:

A) To initiate product recalls
B) To monitor stock levels
C) To ensure transparency and accountability
D) To enhance marketing campaigns

3. The criteria for re-evaluation and revalidation of unit processes include:
(Select three)
Response:

A) Significant process modifications
B) Introduction of new equipment
C) Changes in raw material sources
D) Changes in cafeteria menu

4. Which is the most appropriate disposal method for rejected raw materials?

A) Use for training
B) Return to vendor or destroy
C) Store indefinitely
D) Give to another manufacturer

5. Configuration control in computerized systems ensures that:
Response:

A) The system automatically updates without approval
B) Configuration changes are decided by popular vote among users
C) System settings and versions are properly documented and controlled
D) All users have equal administrative access

Solutions: