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Last Updated: Oct 28, 2026
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ASQ CPGP Exam Syllabus Topics:
| Section | Weight | Objectives |
|---|---|---|
| Regulatory Agency Governance | 12% | - Inspection, enforcement, and compliance processes - Global regulatory framework and requirements |
| Product Development and Technology Transfer | 9% | - Product lifecycle management and regulatory submissions - Technology transfer, scale-up, and validation |
| Infrastructure and Facilities | 12% | - Facility design, maintenance, and utilities management - Equipment qualification, calibration, and cleaning validation |
| Filling, Packaging, and Labeling | 13% | - Filling operations, controls, and verification - Packaging and labeling design and compliance |
| Laboratory Systems | 14% | - Testing methods, data integrity, and result reporting - Laboratory controls, calibration, and validation |
| Quality Systems | 18% | - Documentation, change control, and records management - Audits, corrective and preventive actions - Quality management system design and implementation |
| 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 |
ASQ Certified Pharmaceutical GMP Professional Sample Questions:
When dealing with returned pharmaceutical goods, their ___________ must be carefully evaluated to determine if they can be reissued, recycled, or must be destroyed.
Response:
- A. Disposition
- B. Packaging color
- C. Advertising budget
- D. Price tag
Correct Answer: A 🗳️
Mutual recognition agreements impact the import and export of pharmaceuticals by:
Response:
- A. Ensuring that product prices are consistent across borders.
- B. Facilitating smoother regulatory approval processes between countries.
- C. Increasing the number of required inspections for each product.
- D. Requiring additional testing for all imported or exported products.
Correct Answer: B 🗳️
The layout of equipment in a pharmaceutical manufacturing facility should:Response:
- A. Be arranged based on the personal preferences of the CEO
- B. Prioritize the most expensive equipment
- C. Facilitate effective cleaning and maintenance
- D. Focus on creating a visually appealing setup
Correct Answer: C 🗳️
In the context of Factory and Site Acceptance Testing (FAT/SAT), what are the primary goals?
(Choose two)
Response:
- A. To evaluate the equipment's social media integration capabilities
- B. To confirm that equipment operates correctly in its installed environment
- C. To assess the equipment's compatibility with virtual reality applications
- D. To ensure the equipment meets predefined specifications before delivery
Correct Answer: B,D 🗳️
Which of the following requirements is essential for the manufacture and storage environment in a pharmaceutical facility?
Response:
- A. Presence of a cafeteria within the production area
- B. Availability of a large parking lot
- C. High-tech security systems
- D. Appropriate lighting, ventilation, and drainage
Correct Answer: D 🗳️
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