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ASQ CPGP Exam Syllabus Topics:
| Section | Weight | Objectives |
|---|---|---|
| Infrastructure and Facilities | 12% | - Equipment qualification, calibration, and cleaning validation - Facility design, maintenance, and utilities management |
| Quality Systems | 18% | - Documentation, change control, and records management - Quality management system design and implementation - Audits, corrective and preventive actions |
| Materials and Supply Chain Management | 12% | - Inventory control, traceability, and distribution practices - Supplier qualification, material receipt, and storage |
| Manufacturing Systems | 16% | - Contamination control, cleaning, and hygiene - Process design, validation, and control - Sterile and non-sterile production requirements |
| Filling, Packaging, and Labeling | 13% | - Filling operations, controls, and verification - Packaging and labeling design and compliance |
| Laboratory Systems | 14% | - Testing methods, data integrity, and result reporting - Laboratory controls, calibration, and validation |
| Product Development and Technology Transfer | 9% | - Technology transfer, scale-up, and validation - Product lifecycle management and regulatory submissions |
| Regulatory Agency Governance | 12% | - Inspection, enforcement, and compliance processes - Global regulatory framework and requirements |
ASQ Certified Pharmaceutical GMP Professional Sample Questions:
1. Analytical laboratory site change requires careful __________ of results between sites.
Response:
A) marketing
B) comparison
C) disregard
D) lowering
2. Biological test methods in compendia are designed to:
Response:
A) Replace all chemical and physical tests.
B) Assess only the physical properties of a sample.
C) Determine the biological activity or properties of substances.
D) Be optional for all laboratory testing.
3. The main goal of evaluating the level of action needed in response to adverse events is to:
Response:
A) Ensure customer satisfaction and retention.
B) Determine the financial impact on the company.
C) Minimize legal liability for the company.
D) Protect patient safety and comply with regulatory requirements.
4. Evidence of printed material reconciliation is required to:
Response:
A) Justify budget increases
B) Monitor employee performance
C) Track the number of breaks taken by employees
D) Ensure correct material usage and account for discrepancies
5. What is the primary goal of sanitization procedures in pharmaceutical manufacturing?
Response:
A) To comply with interior design guidelines
B) To create a pleasant scent in the manufacturing area
C) To eliminate or reduce microbial contamination to acceptable levels
D) To ensure equipment and facilities meet aesthetic standards
Solutions:
| Question # 1 Answer: B | Question # 2 Answer: C | Question # 3 Answer: D | Question # 4 Answer: D | Question # 5 Answer: C |
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