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ASQ CPGP Exam Syllabus Topics:
| Section | Weight | Objectives |
|---|---|---|
| Topic 1: Filling, Packaging, and Labeling | 13% | - Filling operations, controls, and verification - Packaging and labeling design and compliance |
| Topic 2: Laboratory Systems | 14% | - Laboratory controls, calibration, and validation - Testing methods, data integrity, and result reporting |
| Topic 3: Materials and Supply Chain Management | 12% | - Supplier qualification, material receipt, and storage - Inventory control, traceability, and distribution practices |
| Topic 4: Infrastructure and Facilities | 12% | - Facility design, maintenance, and utilities management - Equipment qualification, calibration, and cleaning validation |
| Topic 5: Product Development and Technology Transfer | 9% | - Technology transfer, scale-up, and validation - Product lifecycle management and regulatory submissions |
| Topic 6: Manufacturing Systems | 16% | - Contamination control, cleaning, and hygiene - Process design, validation, and control - Sterile and non-sterile production requirements |
| Topic 7: Quality Systems | 18% | - Documentation, change control, and records management - Audits, corrective and preventive actions - Quality management system design and implementation |
| Topic 8: Regulatory Agency Governance | 12% | - Inspection, enforcement, and compliance processes - Global regulatory framework and requirements |
ASQ Certified Pharmaceutical GMP Professional Sample Questions:
1. When reviewing compendial or non-compendial requirements, it is crucial to:
Response:
A) Focus solely on the ease of the test.
B) Ignore the compendial chapters if non-compendial methods are used.
C) Use only the newest methods available, regardless of their compendial status.
D) Ensure test methods are qualified, validated, and verified.
2. The Quality Unit should be independent from operations to avoid any _____.
Response:
A) conflicts of interest
B) cost reductions
C) team collaborations
D) efficiency improvements
3. Calibration and engineering change control procedures are implemented to:
(Choose two)
Response:
A) Maintain the integrity of manufacturing processes
B) Facilitate the live streaming of equipment operations
C) Guarantee that modifications do not affect the precision and accuracy of measurements
D) Ensure equipment settings are optimized for the fastest production time
4. Which document details post-approval changes in pharmaceutical manufacturing?
Response:
A) Clinical Trial Report
B) Product Monograph
C) Marketing Authorization
D) SUPAC guidelines
5. ICH Q7 provides guidance specifically for:
Response:
A) Good Clinical Practice
B) Good Manufacturing Practice
C) Good Distribution Practice
D) Good Laboratory Practice
Solutions:
| Question # 1 Answer: D | Question # 2 Answer: A | Question # 3 Answer: A,C | Question # 4 Answer: D | Question # 5 Answer: B |
