Exam Name: Certified Pharmaceutical GMP Professional
Certification Provider: ASQ
Corresponding Certification: ASQ Auditing
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Check Updated on: Oct 06, 2026
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ASQ CPGP Exam Syllabus Topics:
| Section | Weight | Objectives |
|---|---|---|
| Product Development and Technology Transfer | 9% | - Technology transfer, scale-up, and validation - Product lifecycle management and regulatory submissions |
| Manufacturing Systems | 16% | - Sterile and non-sterile production requirements - Process design, validation, and control - Contamination control, cleaning, and hygiene |
| Laboratory Systems | 14% | - Testing methods, data integrity, and result reporting - Laboratory controls, calibration, and validation |
| Infrastructure and Facilities | 12% | - Facility design, maintenance, and utilities management - Equipment qualification, calibration, and cleaning validation |
| Materials and Supply Chain Management | 12% | - Inventory control, traceability, and distribution practices - Supplier qualification, material receipt, and storage |
| Regulatory Agency Governance | 12% | - Global regulatory framework and requirements - Inspection, enforcement, and compliance processes |
| Quality Systems | 18% | - Documentation, change control, and records management - Audits, corrective and preventive actions - Quality management system design and implementation |
| Filling, Packaging, and Labeling | 13% | - Packaging and labeling design and compliance - Filling operations, controls, and verification |
ASQ Certified Pharmaceutical GMP Professional Sample Questions:
The purpose of maintaining pedigree and sourcing details for APIs and other materials is to:
Response:
- A. Document the supply chain for quality and safety assurance
- B. Simplify the manufacturing process
- C. Reduce the cost of goods sold
- D. Enhance the appearance of the product
Correct Answer: A 🗳️
The use of PAT tools in manufacturing supports:
Response:
- A. The manufacture of quality products
- B. Decreased product quality
- C. Reduced understanding of processes
- D. Increased downtime
Correct Answer: A 🗳️
What is the purpose of routine maintenance for HVAC systems in a pharmaceutical facility?
Response:
- A. To reduce the electricity bill
- B. To ensure optimal performance and minimize contamination risk
- C. To comply with interior design standards
- D. To enhance the aesthetic appeal of the facility
Correct Answer: B 🗳️
Analytical laboratory site change requires careful __________ of results between sites.
Response:
- A. comparison
- B. marketing
- C. lowering
- D. disregard
Correct Answer: A 🗳️
The effectiveness of a QMS is assessed through QMM to ensure:
Response:
- A. Competitive pricing
- B. Effective advertising
- C. Legal compliance
- D. Process and product quality
Correct Answer: C 🗳️
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