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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
|
| Production Systems | 23%-27% | - Manufacturing operations
|
| Quality Management Systems | 22%-26% | - Quality systems
|
| Laboratory Systems | 10%-14% | - Laboratory operations
|
| Facilities and Equipment Systems | 18%-22% | - Facilities
|
ASQ Certified Pharmaceutical GMP Professional Sample Questions:
1. The main difference between systems and process audits is that systems audits evaluate:
Response:
A) The end product quality
B) The entire quality system
C) Individual employee performance
D) The process efficiency only
2. When should specifications be reviewed and updated?
Response:
A) Annually, as a standard procedure
B) Only when the product formula changes
C) When methods are revised or compendia are changed
D) When a new management team is appointed
3. What factor is least important when determining the suitability of a storage environment for pharmaceutical materials?
Response:
A) Temperature and humidity control
B) The cost of the storage facility
C) Protection from contamination
D) Monitoring and control systems
4. Which of the following best describes the purpose of a system-based inspection?
Response:
A) To assess the company's financial and administrative records.
B) To prepare the company for an upcoming product launch.
C) To focus on a specific system within the manufacturing process.
D) To review the company's entire system following a major change or update.
5. In laboratory investigations, the identification of unknowns typically involves:
Response:
A) Guessing based on previous experience
B) Comparing test results to known standards or reference materials
C) Consulting a psychic
D) Using a single test method for identification
Solutions:
| Question # 1 Answer: B | Question # 2 Answer: C | Question # 3 Answer: B | Question # 4 Answer: C | Question # 5 Answer: B |
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