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ASQ CPGP Exam Syllabus Topics:
| Section | Weight | Objectives |
|---|---|---|
| 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 |
| Manufacturing Systems | 16% | - Sterile and non-sterile production requirements - Process design, validation, and control - Contamination control, cleaning, and hygiene |
| Infrastructure and Facilities | 12% | - Equipment qualification, calibration, and cleaning validation - Facility design, maintenance, and utilities management |
| Filling, Packaging, and Labeling | 13% | - Packaging and labeling design and compliance - Filling operations, controls, and verification |
| Quality Systems | 18% | - Audits, corrective and preventive actions - Quality management system design and implementation - Documentation, change control, and records management |
| Laboratory Systems | 14% | - Laboratory controls, calibration, and validation - Testing methods, data integrity, and result reporting |
| Product Development and Technology Transfer | 9% | - Technology transfer, scale-up, and validation - Product lifecycle management and regulatory submissions |
ASQ Certified Pharmaceutical GMP Professional Sample Questions:
1. How can digital reporting benefit a pharmaceutical company during inspections?
Response:
A) By reducing the need for employee training.
B) By eliminating the need for any future inspections.
C) By allowing real-time updates and transparency.
D) By automatically marketing products during the inspection.
2. Which of the following should be assessed during an impact assessment?
(Choose two)
Response:
A) Changes to the company stock price
B) The impact on future marketing campaigns
C) Potential effects on patient safety
D) The effect on product quality
3. What are potential sources of mix-up in material storage, and how can they be minimized?
(Choose two)
Response:
A) Using a single storage area for all types of materials
B) Material segregation
C) Special storage for rejects
D) Uniform labeling for all materials
4. The assessment of staging areas is to ensure:
Response:
A) The comfort of visiting company executives
B) They meet requirements for process control and safety
C) The most efficient use of space for office furniture
D) Adequate lighting for product photography
5. When reviewing cleaning procedures, it is important to verify that they:
(Choose two)
Response:
A) Focus on the use of environmentally friendly cleaning agents only
B) Include details on cleaning schedules and methods
C) Enhance the equipment's aesthetic features
D) Are aligned with the latest cleaning validation
Solutions:
| Question # 1 Answer: C | Question # 2 Answer: C,D | Question # 3 Answer: B,C | Question # 4 Answer: B | Question # 5 Answer: B,D |






