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ASQ CPGP Exam Syllabus Topics:
| Section | Weight | Objectives |
|---|---|---|
| Production Systems | 23%-27% | - Manufacturing operations
|
| Packaging and Labeling Systems | 5%-9% | - Packaging controls
|
| Facilities and Equipment Systems | 18%-22% | - Equipment
|
| Quality Management Systems | 22%-26% | - Quality systems
|
| Materials Systems | 13%-17% | - Material controls
|
| Laboratory Systems | 10%-14% | - Laboratory operations
|
ASQ Certified Pharmaceutical GMP Professional Sample Questions:
Question 1
What action should be taken for materials received with missing documentation?
Response:
A. Quarantine the materials until the documentation is reviewed and approved
B. Discard the materials immediately without further verification
C. Use the materials for non-critical applications only
D. Proceed with using the materials, assuming documentation is not critical
Question 2
For combination products, GMP requirements include:
Response:
A. Treating the product as a simple drug formulation
B. Studies specific to drug-device interactions
C. Ignoring device components
D. Excluding usability studies
Question 3
The use of cut-label procedures and splices is to:
Response:
A. Reduce the effectiveness of inspections
B. Increase label variety
C. Decorate the packaging area
D. Ensure continuous operation and label integrity
Question 4
Material compatibility studies ensure that the product does not __________ with its packaging.
Response:
A. react
B. change color
C. improve in quality
D. increase in price
Question 5
The purpose of critical manufacturing step verification is to ensure:
Response:
A. Compliance with fashion trends
B. The accuracy and reliability of the manufacturing process
C. Employee satisfaction levels
D. The social media strategy is effective
Solutions:
| Question 1 Answer: A | Question 2 Answer: B | Question 3 Answer: D | Question 4 Answer: A | Question 5 Answer: B |
