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ASQ CPGP Exam Syllabus Topics:
| Section | Weight | Objectives |
|---|---|---|
| Topic 1: Materials and Supply Chain Management | 12% | - Supplier qualification, material receipt, and storage - Inventory control, traceability, and distribution practices |
| Topic 2: Quality Systems | 18% | - Audits, corrective and preventive actions - Documentation, change control, and records management - Quality management system design and implementation |
| Topic 3: Laboratory Systems | 14% | - Laboratory controls, calibration, and validation - Testing methods, data integrity, and result reporting |
| Topic 4: Filling, Packaging, and Labeling | 13% | - Filling operations, controls, and verification - Packaging and labeling design and compliance |
| Topic 5: Manufacturing Systems | 16% | - Sterile and non-sterile production requirements - Process design, validation, and control - Contamination control, cleaning, and hygiene |
| Topic 6: Infrastructure and Facilities | 12% | - Facility design, maintenance, and utilities management - Equipment qualification, calibration, and cleaning validation |
| Topic 7: Product Development and Technology Transfer | 9% | - Product lifecycle management and regulatory submissions - Technology transfer, scale-up, and validation |
| Topic 8: Regulatory Agency Governance | 12% | - Global regulatory framework and requirements - Inspection, enforcement, and compliance processes |
ASQ Certified Pharmaceutical GMP Professional Sample Questions:
1. Product recalls are significant because they:
Response:
A) Affect the annual holiday party planning
B) Provide data for marketing strategies
C) Influence the company's stock prices
D) Indicate a need to reassess product design and safety
2. Audit evidence should be _____ to confirm audit completion and findings.
Response:
A) documented
B) estimated
C) ignored
D) deleted
3. Which documents are essential for demonstrating staff development and proficiency?
(Choose two)
Response:
A) Financial statements
B) Vacation records
C) Performance appraisals
D) Training certificates
4. For marketing authorization, the relationship between the USP, EP, and JP is best described as:
Response:
A) Region-specific requirements.
B) Interchangeable.
C) Identical across all regions.
D) Mutually exclusive.
5. Analyzing audit results is crucial to assess _____ to specified requirements.
Response:
A) conformance
B) indifference
C) ignorance
D) opposition
Solutions:
| Question # 1 Answer: D | Question # 2 Answer: A | Question # 3 Answer: C,D | Question # 4 Answer: A | Question # 5 Answer: A |
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