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ASQ CPGP Exam Syllabus Topics:
| Section | Weight | Objectives |
|---|---|---|
| Topic 1: Manufacturing Systems | 16% | - Process design, validation, and control - Sterile and non-sterile production requirements - Contamination control, cleaning, and hygiene |
| Topic 2: Infrastructure and Facilities | 12% | - Equipment qualification, calibration, and cleaning validation - Facility design, maintenance, and utilities management |
| Topic 3: Regulatory Agency Governance | 12% | - Inspection, enforcement, and compliance processes - Global regulatory framework and requirements |
| Topic 4: Quality Systems | 18% | - Audits, corrective and preventive actions - Quality management system design and implementation - Documentation, change control, and records management |
| Topic 5: Laboratory Systems | 14% | - Laboratory controls, calibration, and validation - Testing methods, data integrity, and result reporting |
| Topic 6: Product Development and Technology Transfer | 9% | - Product lifecycle management and regulatory submissions - Technology transfer, scale-up, and validation |
| Topic 7: Filling, Packaging, and Labeling | 13% | - Packaging and labeling design and compliance - Filling operations, controls, and verification |
| Topic 8: Materials and Supply Chain Management | 12% | - Supplier qualification, material receipt, and storage - Inventory control, traceability, and distribution practices |
ASQ Certified Pharmaceutical GMP Professional Sample Questions:
Question 1
In the context of Factory and Site Acceptance Testing (FAT/SAT), what are the primary goals?
(Choose two)
Response:
A. To assess the equipment's compatibility with virtual reality applications
B. To ensure the equipment meets predefined specifications before delivery
C. To evaluate the equipment's social media integration capabilities
D. To confirm that equipment operates correctly in its installed environment
Question 2
Which of the following best describes a product complaint?
Response:
A. A report of a financial loss due to the use of a product.
B. A report of a side effect experienced by a patient or consumer using a pharmaceutical 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.
Question 3
Critical Quality Attributes (CQAs) are:
Response:
A. Arbitrary product characteristics
B. Characteristics that must be controlled within predefined limits
C. Unrelated to product safety and efficacy
D. Only related to product packaging
Question 4
Secure storage of reprocessed and reworked materials is important to prevent:
Response:
A. Cross-contamination
B. Employee satisfaction
C. Efficient use of space
D. Timely production schedules
Question 5
The role of a Qualified Person includes ensuring:
Response:
A. The accuracy of financial reports
B. The efficiency of production processes
C. The effectiveness of marketing campaigns
D. Compliance with regulatory product quality standards
Solutions:
| Question 1 Answer: B,D | Question 2 Answer: C | Question 3 Answer: B | Question 4 Answer: A | Question 5 Answer: D |
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