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ASQ CPGP Exam Syllabus Topics:
| Section | Weight | Objectives |
|---|---|---|
| Regulatory Agency Governance | 12% | - Global regulatory framework and requirements - Inspection, enforcement, and compliance processes |
| Product Development and Technology Transfer | 9% | - Product lifecycle management and regulatory submissions - Technology transfer, scale-up, and validation |
| Filling, Packaging, and Labeling | 13% | - Packaging and labeling design and compliance - Filling operations, controls, and verification |
| Laboratory Systems | 14% | - Laboratory controls, calibration, and validation - Testing methods, data integrity, and result reporting |
| Infrastructure and Facilities | 12% | - Equipment qualification, calibration, and cleaning validation - Facility design, maintenance, and utilities management |
| Materials and Supply Chain Management | 12% | - Supplier qualification, material receipt, and storage - Inventory control, traceability, and distribution practices |
| Manufacturing Systems | 16% | - Contamination control, cleaning, and hygiene - Process design, validation, and control - Sterile and non-sterile production requirements |
| Quality Systems | 18% | - Documentation, change control, and records management - Quality management system design and implementation - Audits, corrective and preventive actions |
ASQ Certified Pharmaceutical GMP Professional Sample Questions:
The investigation of atypical results in biological testing involves reviewing _______ to identify potential sources of error.
Response:
- A. personnel vacation schedules
- B. test protocols, environmental controls, equipment logs
- C. financial reports
- D. marketing strategies
Correct Answer: B 🗳️
Development criteria for in-process inspections should include:
Response:
- A. Marketing feedback loops
- B. Packaging aesthetics
- C. Seal tests
- D. Color preference surveys
Correct Answer: C 🗳️
In-process control studies during technology transfer ensure:
Response:
- A. Consistent product branding
- B. Employee satisfaction
- C. Continual process control
- D. Effective marketing campaigns
Correct Answer: C 🗳️
Quality agreements between parties are crucial for clarifying:
Response:
- A. The use of proprietary software by the supplier
- B. The allocation of tickets for sporting events
- C. Specific roles, responsibilities, and expectations related to quality
- D. Entertainment and hospitality standards during business meetings
Correct Answer: C 🗳️
Stability reports are crucial for new product development because they:
Response:
- A. Outline marketing strategies
- B. Provide competitor analysis
- C. Demonstrate the product's ability to maintain its quality over time
- D. Detail the manufacturing costs
Correct Answer: C 🗳️
