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ASQ CPGP Exam Syllabus Topics:
| Section | Weight | Objectives |
|---|---|---|
| Topic 1: Quality Management Systems | 22%-26% | - Quality systems
|
| Topic 2: Facilities and Equipment Systems | 18%-22% | - Facilities
|
| Topic 3: Laboratory Systems | 10%-14% | - Laboratory operations
|
| Topic 4: Packaging and Labeling Systems | 5%-9% | - Packaging controls
|
| Topic 5: Materials Systems | 13%-17% | - Material controls
|
| Topic 6: Production Systems | 23%-27% | - Manufacturing operations
|
ASQ Certified Pharmaceutical GMP Professional Sample Questions:
How often are European Product Quality Reviews (PQRs) typically conducted?
Response:
- A. Annually
- B. Bi-annually
- C. Every two years
- D. Quarterly
Correct Answer: A 🗳️
The Cp and Cpk indices measure:
Response:
- A. Process and position capability related to specification limits
- B. Employee performance
- C. The effectiveness of marketing campaigns
- D. Financial health of the manufacturing company
Correct Answer: A 🗳️
Routine maintenance of air and water filters in a pharmaceutical facility helps to:
Response:
- A. Prevent contamination and maintain a controlled environment
- B. Impress regulatory inspectors with the facility's cleanliness
- C. Ensure the filters are color-coordinated with the facility interiors
- D. Decrease the workload on facility staff
Correct Answer: A 🗳️
Closed computerized systems are defined by their:
Response:
- A. Use exclusively in social networking contexts
- B. Inability to process data efficiently
- C. Ability to operate on an open internet platform without security
- D. Lack of connectivity with other systems and controlled access
Correct Answer: D 🗳️
What type of specifications must be determined for intermediates used in production?
Response:
- A. Specifications based solely on cost
- B. Specifications agreed upon by the marketing department
- C. Color specifications only
- D. Approved specifications for quality and safety
Correct Answer: D 🗳️
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