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ASQ CPGP Exam Syllabus Topics:
| Section | Weight | Objectives |
|---|---|---|
| Topic 1: Filling, Packaging, and Labeling | 13% | - Packaging and labeling design and compliance - Filling operations, controls, and verification |
| Topic 2: Regulatory Agency Governance | 12% | - Inspection, enforcement, and compliance processes - Global regulatory framework and requirements |
| Topic 3: Infrastructure and Facilities | 12% | - Facility design, maintenance, and utilities management - Equipment qualification, calibration, and cleaning validation |
| Topic 4: Manufacturing Systems | 16% | - Process design, validation, and control - Sterile and non-sterile production requirements - Contamination control, cleaning, and hygiene |
| Topic 5: Materials and Supply Chain Management | 12% | - Inventory control, traceability, and distribution practices - Supplier qualification, material receipt, and storage |
| Topic 6: Quality Systems | 18% | - Documentation, change control, and records management - Quality management system design and implementation - Audits, corrective and preventive actions |
| Topic 7: Product Development and Technology Transfer | 9% | - Technology transfer, scale-up, and validation - Product lifecycle management and regulatory submissions |
| Topic 8: Laboratory Systems | 14% | - Testing methods, data integrity, and result reporting - Laboratory controls, calibration, and validation |
ASQ Certified Pharmaceutical GMP Professional Sample Questions:
Question 1
The main goal of environmental monitoring during scale-up is to:
Response:
A. Ensure regulatory compliance
B. Assess customer satisfaction
C. Monitor employee performance
D. Track stock market trends
Question 2
A root cause analysis is essential for:
Response:
A. Identifying the underlying cause of a detected problem
B. Setting production targets
C. Planning the company picnic
D. Determining who is at fault
Question 3
Before a piece of equipment is used in production, which types of acceptance testing are typically conducted?
(Choose two)
Response:
A. Online Acceptance Testing (OAT)
B. Factory Acceptance Testing (FAT)
C. Site Acceptance Testing (SAT)
D. Personal Acceptance Testing (PAT)
Question 4
Record review processes are essential for ensuring:
Response:
A. Entertainment value of the data
B. Quick disposal of outdated records
C. Uniformity in record formatting
D. Data integrity and preventing data loss
Question 5
What is a critical aspect of laboratory record-keeping requirements?
Response:
A. Guaranteeing data integrity through proper data acquisition systems
B. Using only paper records to avoid electronic errors
C. Ensuring records are colorful and visually appealing
D. Keeping records for no more than one year for space-saving
Solutions:
| Question 1 Answer: A | Question 2 Answer: A | Question 3 Answer: B,C | Question 4 Answer: D | Question 5 Answer: A |
