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ASQ Certified Pharmaceutical GMP Professional Sample Questions:

1. Which of the following are considered when defining corrective actions?
(Choose two)
Response:

A) Actions to improve employee benefits
B) Actions to address and correct the root cause of a problem
C) Actions to enhance marketing strategies
D) Actions to prevent recurrence of the issue

2. Which of the following is a key element evaluated in the European Product Quality Review (PQR)?
Response:

A) Trends in product quality data
B) Customer feedback and satisfaction
C) Compliance with environmental standards
D) Annual sales figures

3. Change control for equipment in the pharmaceutical industry ensures:
Response:

A) Continual compliance and maintenance of the equipment's qualified state
B) A diversity of equipment colors to enhance employee morale
C) The equipment matches the latest fashion trends
D) That equipment can be easily swapped out for newer models

4. What action should be taken for materials received with missing documentation?
Response:

A) Quarantine the materials until the documentation is reviewed and approved
B) Use the materials for non-critical applications only
C) Proceed with using the materials, assuming documentation is not critical
D) Discard the materials immediately without further verification

5. According to regulatory requirements, which characteristic is NOT part of the ALCOA principle for ensuring the integrity of records?
Response:

A) Legible.
B) Optional.
C) Accurate.
D) Original.

Solutions: