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ASQ CPGP Exam Syllabus Topics:
| Section | Weight | Objectives |
|---|---|---|
| Topic 1: Quality Systems | 18% | - Audits, corrective and preventive actions - Quality management system design and implementation - Documentation, change control, and records management |
| Topic 2: Product Development and Technology Transfer | 9% | - Product lifecycle management and regulatory submissions - Technology transfer, scale-up, and validation |
| Topic 3: Infrastructure and Facilities | 12% | - Facility design, maintenance, and utilities management - Equipment qualification, calibration, and cleaning validation |
| Topic 4: Filling, Packaging, and Labeling | 13% | - Filling operations, controls, and verification - Packaging and labeling design and compliance |
| Topic 5: Materials and Supply Chain Management | 12% | - Supplier qualification, material receipt, and storage - Inventory control, traceability, and distribution practices |
| Topic 6: Regulatory Agency Governance | 12% | - Inspection, enforcement, and compliance processes - Global regulatory framework and requirements |
| Topic 7: Manufacturing Systems | 16% | - Process design, validation, and control - Sterile and non-sterile production requirements - Contamination control, cleaning, and hygiene |
| Topic 8: Laboratory Systems | 14% | - Laboratory controls, calibration, and validation - Testing methods, data integrity, and result reporting |
ASQ Certified Pharmaceutical GMP Professional Sample Questions:
1. What are essential elements to review in Certificates of Analysis (COAs)?
(Choose two)
Response:
A) Color of the product
B) Completeness and internal review
C) Marketing claims
D) Appropriate retention and accessibility
2. Continuous manufacturing differs from batch manufacturing in that:
Response:
A) It is only used for solid dosage forms.
B) It requires different utility requirements.
C) It requires more manual intervention.
D) It is a non-stop process that minimizes idle times.
3. Which of the following best describes a product complaint?
Response:
A) A report of a side effect experienced by a patient or consumer using a pharmaceutical product.
B) A report of a financial loss due to the use of a product.
C) A report of any dissatisfaction with a product's quality, identity, durability, reliability, safety, effectiveness, or performance.
D) A report of dissatisfaction concerning a company's service.
4. The role of a Qualified Person includes ensuring:
Response:
A) The efficiency of production processes
B) Compliance with regulatory product quality standards
C) The effectiveness of marketing campaigns
D) The accuracy of financial reports
5. Validation studies for depyrogenation processes must focus on:
Response:
A) Packaging design
B) Social media impact
C) Employee comfort levels
D) Temperature and duration
Solutions:
| Question # 1 Answer: B,D | Question # 2 Answer: D | Question # 3 Answer: C | Question # 4 Answer: B | Question # 5 Answer: D |
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