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ASQ CPGP Exam Syllabus Topics:
| Section | Weight | Objectives |
|---|---|---|
| Quality Systems | 18% | - Quality management system design and implementation - Audits, corrective and preventive actions - Documentation, change control, and records management |
| Filling, Packaging, and Labeling | 13% | - Filling operations, controls, and verification - Packaging and labeling design and compliance |
| Materials and Supply Chain Management | 12% | - Supplier qualification, material receipt, and storage - Inventory control, traceability, and distribution practices |
| Laboratory Systems | 14% | - Testing methods, data integrity, and result reporting - Laboratory controls, calibration, and validation |
| Infrastructure and Facilities | 12% | - Equipment qualification, calibration, and cleaning validation - Facility design, maintenance, and utilities management |
| Manufacturing Systems | 16% | - Process design, validation, and control - Contamination control, cleaning, and hygiene - Sterile and non-sterile production requirements |
| Product Development and Technology Transfer | 9% | - Product lifecycle management and regulatory submissions - Technology transfer, scale-up, and validation |
| Regulatory Agency Governance | 12% | - Global regulatory framework and requirements - Inspection, enforcement, and compliance processes |
ASQ Certified Pharmaceutical GMP Professional Sample Questions:
In the context of APR and PQR, what is the significance of reviewing product complaints?
Response:
- A. To evaluate and improve product quality and safety
- B. To assess the product's packaging design
- C. To adjust the product price
- D. To measure consumer brand loyalty
Correct Answer: A 🗳️
The role of a supervisor in training effectiveness includes:
(Choose three)
Response:
- A. Ensuring staff are adequately trained
- B. Monitoring market trends
- C. Overseeing financial audits
- D. Evaluating training outcomes
Correct Answer: A,B,D 🗳️
To ensure successful technology transfer, it's important to consider:
(Select two)
Response:
- A. Social media marketing strategies
- B. Hold times
- C. Branding guidelines
- D. Shipping conditions
Correct Answer: B,C 🗳️
What is the main purpose of materials control in filling operations?
Response:
- A. Increase production speed
- B. Reduce costs
- C. Ensure the identity, strength, and purity of materials
- D. Simplify process documentation
Correct Answer: C 🗳️
According to regulatory requirements, which characteristic is NOT part of the ALCOA principle for ensuring the integrity of records?
Response:
- A. Legible.
- B. Optional.
- C. Accurate.
- D. Original.
Correct Answer: D 🗳️
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