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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: Materials and Supply Chain Management | 12% | - Inventory control, traceability, and distribution practices - Supplier qualification, material receipt, and storage |
| Topic 3: Laboratory Systems | 14% | - Laboratory controls, calibration, and validation - Testing methods, data integrity, and result reporting |
| Topic 4: Quality Systems | 18% | - Documentation, change control, and records management - Audits, corrective and preventive actions - Quality management system design and implementation |
| Topic 5: Product Development and Technology Transfer | 9% | - Technology transfer, scale-up, and validation - Product lifecycle management and regulatory submissions |
| Topic 6: Filling, Packaging, and Labeling | 13% | - Packaging and labeling design and compliance - Filling operations, controls, and verification |
| Topic 7: Infrastructure and Facilities | 12% | - Facility design, maintenance, and utilities management - Equipment qualification, calibration, and cleaning validation |
| Topic 8: Regulatory Agency Governance | 12% | - Inspection, enforcement, and compliance processes - Global regulatory framework and requirements |
ASQ Certified Pharmaceutical GMP Professional Sample Questions:
Equipment used in packaging operations must be __________ and maintained.
Response:
- A. outsourced
- B. qualified
- C. decorated
- D. manually operated
Correct Answer: B 🗳️
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
Correct Answer: A 🗳️
Which organization provides guidelines on veterinary pharmaceuticals and biologicals?
Response:
- A. FDA
- B. USDA
- C. WHO
- D. EMA
Correct Answer: B 🗳️
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
Correct Answer: C 🗳️
Content protection procedures are developed to prevent:
(Select two)
Response:
- A. Marketing influence
- B. Environmental alterations
- C. Over-branding
- D. Event-related damage
Correct Answer: B,D 🗳️
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