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ASQ CPGP Exam Syllabus Topics:
| Section | Weight | Objectives |
|---|---|---|
| Laboratory Systems | 14% | - Laboratory controls, calibration, and validation - Testing methods, data integrity, and result reporting |
| Infrastructure and Facilities | 12% | - Facility design, maintenance, and utilities management - Equipment qualification, calibration, and cleaning validation |
| Regulatory Agency Governance | 12% | - Inspection, enforcement, and compliance processes - Global regulatory framework and requirements |
| Product Development and Technology Transfer | 9% | - Product lifecycle management and regulatory submissions - Technology transfer, scale-up, and validation |
| 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 |
| Materials and Supply Chain Management | 12% | - Supplier qualification, material receipt, and storage - Inventory control, traceability, and distribution practices |
| Quality Systems | 18% | - Documentation, change control, and records management - Audits, corrective and preventive actions - Quality management system design and implementation |
ASQ Certified Pharmaceutical GMP Professional Sample Questions:
Differentiating between sterile and nonsterile manufacturing, which of the following is NOT a factor?
Response:
- A. The microbiological testing standards
- B. The packaging material color
- C. The level of environmental control
- D. The requirement for aseptic processing
Correct Answer: B 🗳️
Which of the following are considered when reviewing compendial methods for suitability in the testing lab?
(Choose two)
Response:
- A. The popularity of the method among laboratory staff
- B. The specific application of the test method
- C. The color of the reagents used
- D. The verification of the method's performance
Correct Answer: B,D 🗳️
Sourcing requirements for APIs and excipients ensure that:
Response:
- A. The supply chain is documented for integrity and compliance
- B. Products have unique colors
- C. Products can be produced at the lowest cost
- D. Marketing campaigns can be launched quickly
Correct Answer: A 🗳️
Regular __________ is crucial to ensuring the effectiveness of contamination control measures.
Response:
- A. Reduction of staff
- B. Decrease in cleaning frequency
- C. Expansion of production lines
- D. Monitoring
Correct Answer: D 🗳️
Regulatory requirements for the reporting of adverse events often include the need to report:
Response:
- A. Only those events that have been proven to be directly caused by the product.
- B. Any event that could potentially be related to the product, including counterfeit products and fraud.
- C. Events that have occurred more than once.
- D. Only events that occur in more than one country.
Correct Answer: B 🗳️
