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ASQ CPGP Exam Syllabus Topics:
| Section | Weight | Objectives |
|---|---|---|
| Filling, Packaging, and Labeling | 13% | - Filling operations, controls, and verification - Packaging and labeling design and compliance |
| Manufacturing Systems | 16% | - Contamination control, cleaning, and hygiene - Process design, validation, and control - Sterile and non-sterile production requirements |
| Product Development and Technology Transfer | 9% | - Product lifecycle management and regulatory submissions - Technology transfer, scale-up, and validation |
| Quality Systems | 18% | - Audits, corrective and preventive actions - Quality management system design and implementation - Documentation, change control, and records management |
| Materials and Supply Chain Management | 12% | - Inventory control, traceability, and distribution practices - Supplier qualification, material receipt, and storage |
| Regulatory Agency Governance | 12% | - Inspection, enforcement, and compliance processes - Global regulatory framework and requirements |
| Laboratory Systems | 14% | - Testing methods, data integrity, and result reporting - Laboratory controls, calibration, and validation |
| Infrastructure and Facilities | 12% | - Facility design, maintenance, and utilities management - Equipment qualification, calibration, and cleaning validation |
ASQ Certified Pharmaceutical GMP Professional Sample Questions:
Question 1
The Quality Management Maturity assessment is used to:
Response:
A. Ensure the QMS evolves with the product and processes
B. Evaluate employee satisfaction
C. Validate financial investment decisions
D. Check the effectiveness of marketing campaigns
Question 2
Requirements related to biological agents like BSE and TSE are important to prevent:
Response:
A. Transmission of disease through pharmaceutical products
B. Changes in packaging design
C. Fluctuations in stock prices
D. Interruptions in marketing campaigns
Question 3
Environmental monitoring is least likely to be a focus during which phase of product development?
Response:
A. Product concept development
B. Phase I clinical trials
C. Pre-clinical trials
D. Commercial production
Question 4
The FDA's regulations are crucial for pharmaceuticals in the USA. What does FDA stand for?
Response:
A. Federal Drug Agency
B. Food and Drug Administration
C. Food and Dietary Association
D. Federal Department of Agriculture
Question 5
How should inventory transactions be documented to maintain effective inventory controls?
Response:
A. On social media platforms for transparency
B. By memorizing transactions
C. Informally, based on staff availability
D. Using a formal, documented process to update inventory records
Solutions:
| Question 1 Answer: A | Question 2 Answer: A | Question 3 Answer: A | Question 4 Answer: B | Question 5 Answer: D |
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