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ASQ CPGP Exam Syllabus Topics:
| Section | Weight | Objectives |
|---|---|---|
| Topic 1: Infrastructure and Facilities | 12% | - Facility design, maintenance, and utilities management - Equipment qualification, calibration, and cleaning validation |
| Topic 2: Quality Systems | 18% | - Documentation, change control, and records management - Audits, corrective and preventive actions - Quality management system design and implementation |
| Topic 3: Laboratory Systems | 14% | - Laboratory controls, calibration, and validation - Testing methods, data integrity, and result reporting |
| Topic 4: Materials and Supply Chain Management | 12% | - Supplier qualification, material receipt, and storage - Inventory control, traceability, and distribution practices |
| Topic 5: Filling, Packaging, and Labeling | 13% | - Filling operations, controls, and verification - Packaging and labeling design and compliance |
| Topic 6: Product Development and Technology Transfer | 9% | - Product lifecycle management and regulatory submissions - Technology transfer, scale-up, and validation |
| Topic 7: Regulatory Agency Governance | 12% | - Global regulatory framework and requirements - Inspection, enforcement, and compliance processes |
| Topic 8: Manufacturing Systems | 16% | - Process design, validation, and control - Contamination control, cleaning, and hygiene - Sterile and non-sterile production requirements |
ASQ Certified Pharmaceutical GMP Professional Sample Questions:
Which of the following is a criterion for further investigation of atypical laboratory results?
Response:
- A. Results are within trend but just outside of specification limits
- B. Only results that are favorable to the desired outcome
- C. All atypical results, regardless of impact
- D. Atypical results are confirmed and significantly impact product quality
Correct Answer: D 🗳️
Product audits evaluate the final _____ to ensure it meets all specifications and requirements.
Response:
- A. proposal
- B. process
- C. product
- D. idea
Correct Answer: C 🗳️
What is essential for ensuring the storage environment is suitable for the type of materials stored?
Response:
- A. Decorating storage areas to boost employee morale
- B. Ensuring the environment is controlled and monitored as required
- C. Using the same storage conditions for all types of materials
- D. Color-coding storage areas based on aesthetics
Correct Answer: B 🗳️
Which factor is least relevant when determining the requirements for a sampling environment?
Response:
- A. The adequacy of the lighting and ventilation
- B. The type of material being sampled
- C. The latest interior design trends
- D. The potential for contamination
Correct Answer: C 🗳️
Filling equipment must be controlled to:
Response:
- A. Reduce energy consumption
- B. Enhance aesthetic appeal
- C. Decrease maintenance time
- D. Verify filling criteria are met
Correct Answer: D 🗳️
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