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ASQ CPGP Exam Syllabus Topics:
| Section | Weight | Objectives |
|---|---|---|
| Infrastructure and Facilities | 12% | - Equipment qualification, calibration, and cleaning validation - Facility design, maintenance, and utilities management |
| Laboratory Systems | 14% | - Testing methods, data integrity, and result reporting - Laboratory controls, calibration, and validation |
| Quality Systems | 18% | - Documentation, change control, and records management - Audits, corrective and preventive actions - Quality management system design and implementation |
| Manufacturing Systems | 16% | - Contamination control, cleaning, and hygiene - Process design, validation, and control - Sterile and non-sterile production requirements |
| Filling, Packaging, and Labeling | 13% | - Packaging and labeling design and compliance - Filling operations, controls, and verification |
| Regulatory Agency Governance | 12% | - Global regulatory framework and requirements - Inspection, enforcement, and compliance processes |
| Product Development and Technology Transfer | 9% | - Product lifecycle management and regulatory submissions - Technology transfer, scale-up, and validation |
| 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:
Trend analysis in the context of CAPA is crucial for:
Response:
- A. Planning social media campaigns
- B. Designing new product lines
- C. Predicting stock market trends
- D. Identifying recurring or new issues
Correct Answer: D 🗳️
Specifications for packaging components and labels are important to ensure:
Response:
- A. The color scheme matches the brand identity
- B. Compliance with regulatory and safety requirements
- C. The cheapest materials are used
- D. Packaging is easy to open by all customers
Correct Answer: B 🗳️
Change control practices within facilities are used to:
Response:
- A. Decorate the facilities according to current trends
- B. Increase the production capacity instantly
- C. Maintain the qualified state of the facilities
- D. Reduce the cost of raw materials
Correct Answer: C 🗳️
Why is stock rotation crucial in a pharmaceutical warehouse?
Response:
- A. It ensures materials are used based on aesthetic preferences.
- B. It allows for easier accounting practices.
- C. It is only a recommendation, not a requirement.
- D. It prevents the use of materials that are beyond their expiry/retest dates.
Correct Answer: D 🗳️
Destruction processes must ensure that materials are disposed of without harming the
___________.
Response:
- A. Packaging design
- B. Environment
- C. Company's profit margins
- D. Marketing strategies
Correct Answer: B 🗳️
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