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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: Regulatory Agency Governance | 12% | - Inspection, enforcement, and compliance processes - Global regulatory framework and requirements |
| Topic 3: Infrastructure and Facilities | 12% | - Facility design, maintenance, and utilities management - Equipment qualification, calibration, and cleaning validation |
| Topic 4: Materials and Supply Chain Management | 12% | - Inventory control, traceability, and distribution practices - Supplier qualification, material receipt, and storage |
| Topic 5: Product Development and Technology Transfer | 9% | - Technology transfer, scale-up, and validation - Product lifecycle management and regulatory submissions |
| Topic 6: Laboratory Systems | 14% | - Laboratory controls, calibration, and validation - Testing methods, data integrity, and result reporting |
| Topic 7: Filling, Packaging, and Labeling | 13% | - Packaging and labeling design and compliance - Filling operations, controls, and verification |
| Topic 8: 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:
1. Equipment used in packaging operations must be __________ and maintained.
Response:
A) outsourced
B) qualified
C) decorated
D) manually operated
2. When an instrument is found to be out of calibration, the immediate step is to _______ before further use.
Response:
A) recalibrate the instrument
B) sell the instrument
C) use the instrument for training purposes
D) continue using the instrument for non-critical tests
3. Which organization provides guidelines on veterinary pharmaceuticals and biologicals?
Response:
A) FDA
B) USDA
C) WHO
D) EMA
4. Critical Quality Attributes (CQAs) are:
Response:
A) Arbitrary product characteristics
B) Only related to product packaging
C) Characteristics that must be controlled within predefined limits
D) Unrelated to product safety and efficacy
5. Content protection procedures are developed to prevent:
(Select two)
Response:
A) Marketing influence
B) Environmental alterations
C) Over-branding
D) Event-related damage
Solutions:
| Question # 1 Answer: B | Question # 2 Answer: A | Question # 3 Answer: B | Question # 4 Answer: C | Question # 5 Answer: B,D |






