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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 |
| Materials and Supply Chain Management | 12% | - Supplier qualification, material receipt, and storage - Inventory control, traceability, and distribution practices |
| Product Development and Technology Transfer | 9% | - Technology transfer, scale-up, and validation - Product lifecycle management and regulatory submissions |
| Laboratory Systems | 14% | - Testing methods, data integrity, and result reporting - Laboratory controls, calibration, and validation |
| Manufacturing Systems | 16% | - Process design, validation, and control - Contamination control, cleaning, and hygiene - Sterile and non-sterile production requirements |
| Quality Systems | 18% | - Quality management system design and implementation - Documentation, change control, and records management - Audits, corrective and preventive actions |
| Filling, Packaging, and Labeling | 13% | - Packaging and labeling design and compliance - Filling operations, controls, and verification |
| Infrastructure and Facilities | 12% | - Equipment qualification, calibration, and cleaning validation - Facility design, maintenance, and utilities management |
ASQ Certified Pharmaceutical GMP Professional Sample Questions:
The adequacy of controls over procurement from suppliers is assessed to:
Response:
- A. Determine if the supplier can host impressive business dinners
- B. Ensure the reliability and quality of raw materials, components, and services
- C. Promote the supplier's products over competitors
- D. Influence the supplier's operational decisions
Correct Answer: B 🗳️
Which of the following are considered global regulatory reporting requirements?
(Choose three)
Response:
- A. Supplements
- B. Marketing approvals
- C. Product recalls
- D. Field alerts
Correct Answer: A,C,D 🗳️
What is the primary purpose of having approved specifications for raw materials and finished products?
Response:
- A. To ensure they meet designated quality and safety standards
- B. To simplify the packaging process
- C. To increase the speed of production
- D. To reduce the cost of production
Correct Answer: A 🗳️
Design space in Quality by Design (QbD) refers to:
Response:
- A. A concept only relevant to product design teams
- B. A multidimensional combination of input parameters and process controls
- C. The layout of laboratory equipment
- D. The physical space in the manufacturing area
Correct Answer: B 🗳️
What is the significance of import alerts in the context of enforcement actions?
Response:
- A. They indicate exceptional product quality and compliance.
- B. They notify about restrictions or bans on the importation of certain products.
- C. They provide incentives for importing novel pharmaceuticals.
- D. They announce new partnership opportunities.
Correct Answer: B 🗳️
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