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ASQ CPGP Exam Syllabus Topics:
| Section | Weight | Objectives |
|---|---|---|
| Materials Systems | 13%-17% | - Material controls
|
| Packaging and Labeling Systems | 5%-9% | - Packaging controls
|
| Laboratory Systems | 10%-14% | - Laboratory operations
|
| Facilities and Equipment Systems | 18%-22% | - Equipment
|
| Quality Management Systems | 22%-26% | - Quality systems
|
| Production Systems | 23%-27% | - Manufacturing operations
|
ASQ Certified Pharmaceutical GMP Professional Sample Questions:
What is the primary objective of mutual recognition agreements in pharmaceutical regulations?
Response:
- A. To recognize the regulatory inspections and approvals of other jurisdictions.
- B. To create a single pharmaceutical market across countries.
- C. To unify the prices of pharmaceutical products globally.
- D. To standardize the branding of pharmaceutical products.
Correct Answer: A 🗳️
Filling equipment must be controlled to:
Response:
- A. Verify filling criteria are met
- B. Decrease maintenance time
- C. Enhance aesthetic appeal
- D. Reduce energy consumption
Correct Answer: A 🗳️
Controls to prevent contamination during filling include:
(Select two)
Response:
- A. Regular equipment calibration
- B. Use of HEPA filters
- C. Reducing production speeds
- D. Employee training programs
Correct Answer: A,B 🗳️
The main difference between systems and process audits is that systems audits evaluate:
Response:
- A. The process efficiency only
- B. Individual employee performance
- C. The end product quality
- D. The entire quality system
Correct Answer: D 🗳️
Packaging line setup instructions are crucial for ensuring:
Response:
- A. Decorative consistency
- B. Correct assembly of components
- C. Marketing alignment
- D. Financial efficiency
Correct Answer: B 🗳️
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