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ASQ CPGP Exam Syllabus Topics:
| Section | Weight | Objectives |
|---|---|---|
| Production Systems | 23%-27% | - Manufacturing operations
|
| Materials Systems | 13%-17% | - Material controls
|
| Facilities and Equipment Systems | 18%-22% | - Facilities
|
| Packaging and Labeling Systems | 5%-9% | - Packaging controls
|
| Laboratory Systems | 10%-14% | - Laboratory operations
|
| Quality Management Systems | 22%-26% | - Quality systems
|
ASQ Certified Pharmaceutical GMP Professional Sample Questions:
Stability-indicating tests differ from release tests in that they:
Response:
- A. Focus on the product's immediate quality upon release
- B. Assess the product's packaging integrity
- C. Are designed to predict the product's stability over time
- D. Are used to determine the product's color and texture
Correct Answer: C 🗳️
Validation studies for lyophilization processes must specifically evaluate:
Response:
- A. The popularity of the product among employees
- B. Shelf temperature and sublimation rates
- C. The color of the lyophilized product
- D. The layout of the manufacturing facility
Correct Answer: B 🗳️
The design of water supply systems in pharmaceutical manufacturing should consider:
Response:
- A. The color of the water
- B. Unit operations like dechlorination and reverse osmosis
- C. The proximity to natural water bodies
- D. Taste preferences of the staff
Correct Answer: B 🗳️
Audit follow-up actions are necessary to:Response:
- A. Reward the audited team
- B. Check the effectiveness of implemented corrective actions
- C. Finalize audit schedules for the next cycle
- D. Conduct team-building activities
Correct Answer: B 🗳️
Line clearance operations must be:Response:
- A. Conducted biannually
- B. Optional based on production schedules
- C. Performed and documented
- D. Skipped to save time
Correct Answer: C 🗳️
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