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ASQ CPGP Exam Syllabus Topics:
| Section | Objectives |
|---|---|
| Quality Control and Laboratory Systems | - Testing and release systems
|
| Validation and Qualification | - Validation lifecycle
|
| Production and Process Control | - Manufacturing operations
|
| Pharmaceutical Quality Systems | - Quality system principles and implementation
|
| Documentation and Data Integrity | - GMP documentation practices
|
| GMP Regulations and Compliance | - Inspection readiness
|
ASQ Certified Pharmaceutical GMP Professional Sample Questions:
Analyzing audit results is crucial to assess _____ to specified requirements.
Response:
- A. ignorance
- B. indifference
- C. conformance
- D. opposition
Correct Answer: C 🗳️
Supplier evaluation methodologies are crucial for:
Response:
- A. Maintaining a competitive edge in supplier negotiations
- B. Assessing and ensuring the quality and reliability of the supplier's products or services
- C. Simplifying procurement processes to reduce administrative workload
- D. Ensuring suppliers have an attractive branding strategy
Correct Answer: B 🗳️
Environmental monitoring in sterile areas focuses primarily on:
- A. Noise
- B. Humidity only
- C. Microbial and particulate levels
- D. Water use
Correct Answer: C 🗳️
What are essential aspects to verify during the Installation Qualification (IQ) of new manufacturing equipment?
(Choose two)
Response:
- A. That the equipment has been installed as per the manufacturer's recommendations
- B. That the equipment color matches the facility interior
- C. That the equipment is endorsed by celebrities
- D. That the installation complies with design specifications
Correct Answer: A,D 🗳️
Environmental monitoring is least likely to be a focus during which phase of product development?
Response:
- A. Commercial production
- B. Pre-clinical trials
- C. Phase I clinical trials
- D. Product concept development
Correct Answer: D 🗳️
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