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ASQ CPGP Exam Syllabus Topics:
| Section | Weight | Objectives |
|---|---|---|
| Facilities and Equipment Systems | 18%-22% | - Facilities
|
| Quality Management Systems | 22%-26% | - Quality systems
|
| Production Systems | 23%-27% | - Manufacturing operations
|
| Materials Systems | 13%-17% | - Material controls
|
| Packaging and Labeling Systems | 5%-9% | - Packaging controls
|
| Laboratory Systems | 10%-14% | - Laboratory operations
|
ASQ Certified Pharmaceutical GMP Professional Sample Questions:
Differentiating between sterile and nonsterile manufacturing, which of the following is NOT a factor?
Response:
- A. The packaging material color
- B. The microbiological testing standards
- C. The level of environmental control
- D. The requirement for aseptic processing
Correct Answer: A 🗳️
In the context of Factory and Site Acceptance Testing (FAT/SAT), what are the primary goals?
(Choose two)
Response:
- A. To confirm that equipment operates correctly in its installed environment
- B. To ensure the equipment meets predefined specifications before delivery
- C. To assess the equipment's compatibility with virtual reality applications
- D. To evaluate the equipment's social media integration capabilities
Correct Answer: A,B 🗳️
A Drug Master File (DMF) is used to:
Response:
- A. Record the company's annual drug sales
- B. List all drugs produced at a facility
- C. Serve as a marketing tool for new pharmaceuticals
- D. Provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more drugs
Correct Answer: D 🗳️
In laboratory investigations, the identification of unknowns typically involves:
Response:
- A. Comparing test results to known standards or reference materials
- B. Guessing based on previous experience
- C. Using a single test method for identification
- D. Consulting a psychic
Correct Answer: A 🗳️
Risk management principles in ICH Q9 should be applied:
Response:
- A. Only post-market
- B. Only at the beginning of product development
- C. Throughout the product lifecycle
- D. Exclusively during clinical trials
Correct Answer: C 🗳️
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