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ASQ CPGP Exam Syllabus Topics:
| Section | Weight | Objectives |
|---|---|---|
| Laboratory Systems | 14% | - Testing methods, data integrity, and result reporting - Laboratory controls, calibration, and validation |
| Infrastructure and Facilities | 12% | - Equipment qualification, calibration, and cleaning validation - Facility design, maintenance, and utilities management |
| Quality Systems | 18% | - Quality management system design and implementation - Documentation, change control, and records management - Audits, corrective and preventive actions |
| Regulatory Agency Governance | 12% | - Inspection, enforcement, and compliance processes - Global regulatory framework and requirements |
| Materials and Supply Chain Management | 12% | - Inventory control, traceability, and distribution practices - Supplier qualification, material receipt, and storage |
| Filling, Packaging, and Labeling | 13% | - Packaging and labeling design and compliance - Filling operations, controls, and verification |
| Product Development and Technology Transfer | 9% | - Product lifecycle management and regulatory submissions - Technology transfer, scale-up, and validation |
| Manufacturing Systems | 16% | - Sterile and non-sterile production requirements - Process design, validation, and control - Contamination control, cleaning, and hygiene |
ASQ Certified Pharmaceutical GMP Professional Sample Questions:
1. Record review processes are essential for ensuring:
Response:
A) Uniformity in record formatting
B) Quick disposal of outdated records
C) Entertainment value of the data
D) Data integrity and preventing data loss
2. Which factors should be analyzed post-change?
(Choose two)
Response:
A) Impact on product quality
B) New risk factors
C) Cost-effectiveness
D) Employee satisfaction
3. What is a key method to minimize the risk of material mix-ups?
Response:
A) Assigning storage based on the material's color
B) Using the same storage containers for all materials
C) Storing all materials together to save space
D) Implementing lot-control methods and proper labeling
4. The Site Reference File (SRF) is essential for:
Response:
A) Investors analyzing the company's stock
B) Potential customers assessing product range
C) Competitors analyzing market strategy
D) Regulators understanding the site's operations and quality management
5. Variations to dossiers and applications are made to:
Response:
A) Announce new executive hires
B) Announce new executive hires
C) Reflect changes in the product or its manufacturing process
D) Update the company's contact information
Solutions:
| Question # 1 Answer: D | Question # 2 Answer: A,B | Question # 3 Answer: D | Question # 4 Answer: D | Question # 5 Answer: C |
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