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ASQ CPGP Exam Syllabus Topics:
| Section | Weight | Objectives |
|---|---|---|
| Topic 1: Product Development and Technology Transfer | 9% | - Product lifecycle management and regulatory submissions - Technology transfer, scale-up, and validation |
| Topic 2: Infrastructure and Facilities | 12% | - Equipment qualification, calibration, and cleaning validation - Facility design, maintenance, and utilities management |
| Topic 3: Filling, Packaging, and Labeling | 13% | - Filling operations, controls, and verification - Packaging and labeling design and compliance |
| Topic 4: Quality Systems | 18% | - Documentation, change control, and records management - Audits, corrective and preventive actions - Quality management system design and implementation |
| Topic 5: Regulatory Agency Governance | 12% | - Inspection, enforcement, and compliance processes - Global regulatory framework and requirements |
| Topic 6: Laboratory Systems | 14% | - Testing methods, data integrity, and result reporting - Laboratory controls, calibration, and validation |
| Topic 7: Materials and Supply Chain Management | 12% | - Inventory control, traceability, and distribution practices - Supplier qualification, material receipt, and storage |
| Topic 8: Manufacturing Systems | 16% | - Process design, validation, and control - Contamination control, cleaning, and hygiene - Sterile and non-sterile production requirements |
ASQ Certified Pharmaceutical GMP Professional Sample Questions:
1. Automated inspection processes must be:
Response:
A) Validated
B) Less prioritized than manual inspections
C) Conducted manually first
D) Based on staff preference
2. Which of the following statements about sanitization and protection in manufacturing is true?
Response:
A) Only required for liquid products
B) Essential for maintaining product quality and safety
C) Not necessary for solid dosage forms
D) Only applies to nonsterile manufacturing environments
3. Appropriate documentation and approval for reprocessed or reworked materials ensure
__________.
Response:
A) Regulatory compliance
B) Untracked material usage
C) Chaos in production
D) Decreased product quality
4. The primary reason for the identification and labeling requirements for samples, reagents, and standards is to:
Response:
A) Enhance the laboratory's reputation
B) Fulfill an arbitrary regulatory requirement
C) Ensure the accuracy and reliability of test results
D) Increase the workload of laboratory staff
5. What is the primary purpose of having approved specifications for raw materials and finished products?
Response:
A) To reduce the cost of production
B) To increase the speed of production
C) To ensure they meet designated quality and safety standards
D) To simplify the packaging process
Solutions:
| Question # 1 Answer: A | Question # 2 Answer: B | Question # 3 Answer: A | Question # 4 Answer: C | Question # 5 Answer: C |
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