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ASQ CPGP Exam Syllabus Topics:
| Section | Weight | Objectives |
|---|---|---|
| Topic 1: Manufacturing Systems | 16% | - Process design, validation, and control - Contamination control, cleaning, and hygiene - Sterile and non-sterile production requirements |
| Topic 2: Product Development and Technology Transfer | 9% | - Product lifecycle management and regulatory submissions - Technology transfer, scale-up, and validation |
| Topic 3: Quality Systems | 18% | - Quality management system design and implementation - Documentation, change control, and records management - Audits, corrective and preventive actions |
| Topic 4: Laboratory Systems | 14% | - Testing methods, data integrity, and result reporting - Laboratory controls, calibration, and validation |
| Topic 5: Filling, Packaging, and Labeling | 13% | - Packaging and labeling design and compliance - Filling operations, controls, and verification |
| Topic 6: Regulatory Agency Governance | 12% | - Inspection, enforcement, and compliance processes - Global regulatory framework and requirements |
| Topic 7: Materials and Supply Chain Management | 12% | - Inventory control, traceability, and distribution practices - Supplier qualification, material receipt, and storage |
| Topic 8: Infrastructure and Facilities | 12% | - Facility design, maintenance, and utilities management - Equipment qualification, calibration, and cleaning validation |
ASQ Certified Pharmaceutical GMP Professional Sample Questions:
The need for formal contracts or quality agreements is determined by:
Response:
- A. The number of likes on the supplier's social media page
- B. The supplier's brand reputation
- C. The geographical distance between the supplier and the manufacturer
- D. The complexity and criticality of the supplied product or service
Correct Answer: D 🗳️
Which of the following dosage forms may require specific utility requirements in manufacturing?
(Select three)
Response:
- A. Liquids
- B. Gases
- C. Solids
- D. Semisolids
Correct Answer: A,C,D 🗳️
Laboratory record-keeping systems must ensure:
(Choose two)
Response:
- A. Annual disposal of old records to save space
- B. Data integrity and security
- C. Decorative elements for record presentation
- D. Ease of access for authorized personnel
Correct Answer: B,D 🗳️
Which act is primarily concerned with the regulation of pharmaceuticals in the United States?
Response:
- A. The Fair Packaging and Labeling Act
- B. The Federal Food, Drug, and Cosmetic Act
- C. The Consumer Product Safety Act
- D. The Clean Air Act
Correct Answer: B 🗳️
An effective post-change analysis should:
(Choose two)
Response:
- A. Propose additional changes indiscriminately
- B. Identify and evaluate any new risks or issues
- C. Validate the change with external benchmarks
- D. Confirm alignment with initial objectives
Correct Answer: B,D 🗳️






