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ASQ CPGP Exam Syllabus Topics:
| Section | Weight | Objectives |
|---|---|---|
| Laboratory Systems | 14% | - Laboratory controls, calibration, and validation - Testing methods, data integrity, and result reporting |
| Regulatory Agency Governance | 12% | - Inspection, enforcement, and compliance processes - Global regulatory framework and requirements |
| Filling, Packaging, and Labeling | 13% | - Filling operations, controls, and verification - Packaging and labeling design and compliance |
| Manufacturing Systems | 16% | - Sterile and non-sterile production requirements - Contamination control, cleaning, and hygiene - Process design, validation, and control |
| Materials and Supply Chain Management | 12% | - Inventory control, traceability, and distribution practices - Supplier qualification, material receipt, and storage |
| Product Development and Technology Transfer | 9% | - Technology transfer, scale-up, and validation - Product lifecycle management and regulatory submissions |
| Infrastructure and Facilities | 12% | - Equipment qualification, calibration, and cleaning validation - Facility design, maintenance, and utilities management |
| Quality Systems | 18% | - Audits, corrective and preventive actions - Documentation, change control, and records management - Quality management system design and implementation |
ASQ Certified Pharmaceutical GMP Professional Sample Questions:
Effective management of contract manufacturing should include:
(Choose two)
Response:
- A. Regular audits and reviews of the contractor's quality system
- B. Decisions based primarily on the ease of contract termination
- C. Ignoring industry standards as long as contractual terms are met
- D. Clear communication of expected outcomes and performance metrics
Correct Answer: A,D 🗳️
Contingency planning for automated systems is crucial to:
Response:
- A. Test and verify the effectiveness of plans in real-world scenarios
- B. Guarantee that system updates occur only during business hours
- C. Ensure the aesthetic continuity of system interfaces across different platforms
- D. Allow for unlimited access to data by all users, ensuring transparency
Correct Answer: A 🗳️
Which of the following are essential aspects of metrology change control in the pharmaceutical industry?
(Choose two)
Response:
- A. Documenting and reviewing engineering changes
- B. Ensuring calibration procedures are up-to-date
- C. Regular updates to the facility's website
- D. Continuous monitoring of social media trends
Correct Answer: A,B 🗳️
Which ICH guideline focuses on Quality Risk Management?
Response:
- A. ICH Q10
- B. ICH Q9
- C. ICH Q11
- D. ICH Q12
Correct Answer: B 🗳️
Analytical laboratory site change requires careful __________ of results between sites.
Response:
- A. lowering
- B. marketing
- C. disregard
- D. comparison
Correct Answer: D 🗳️
