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ASQ CPGP Exam Syllabus Topics:
| Section | Weight | Objectives |
|---|---|---|
| Laboratory Systems | 14% | - Testing methods, data integrity, and result reporting - Laboratory controls, calibration, and validation |
| Product Development and Technology Transfer | 9% | - Product lifecycle management and regulatory submissions - Technology transfer, scale-up, and validation |
| Materials and Supply Chain Management | 12% | - Inventory control, traceability, and distribution practices - Supplier qualification, material receipt, and storage |
| Manufacturing Systems | 16% | - Process design, validation, and control - Sterile and non-sterile production requirements - Contamination control, cleaning, and hygiene |
| Regulatory Agency Governance | 12% | - Global regulatory framework and requirements - Inspection, enforcement, and compliance processes |
| Infrastructure and Facilities | 12% | - Facility design, maintenance, and utilities management - Equipment qualification, calibration, and cleaning validation |
| 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:
How should a pharmaceutical company prepare for a remote evaluation?
Response:
- A. By revising their product pricing strategy.
- B. By increasing the security around their physical facilities.
- C. By training staff on remote communication tools and digital documentation practices.
- D. By organizing a public relations campaign.
Which of the following should be assessed during an impact assessment?
(Choose two)
Response:
- A. Potential effects on patient safety
- B. Changes to the company stock price
- C. The impact on future marketing campaigns
- D. The effect on product quality
The purpose of compendial methods in the testing of pharmaceuticals is to:
Response:
- A. Create a competitive advantage for certain pharmaceutical companies.
- B. Ensure that all testing is done in the least amount of time possible.
- C. Reduce the need for regulatory oversight in pharmaceutical manufacturing.
- D. Provide a standardized approach to testing for quality, safety, and efficacy.
Process capability indices (Cp and Cpk) are used to:
Response:
- A. Predict future financial performance
- B. Measure the process's ability to produce within specified limits
- C. Assess employee productivity
- D. Calculate raw material costs
The use of PAT tools in manufacturing supports:
Response:
- A. Increased downtime
- B. Decreased product quality
- C. Reduced understanding of processes
- D. The manufacture of quality products
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