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ASQ CPGP Exam Syllabus Topics:
| Section | Weight | Objectives |
|---|---|---|
| Regulatory Agency Governance | 12% | - Inspection, enforcement, and compliance processes - Global regulatory framework and requirements |
| Infrastructure and Facilities | 12% | - Facility design, maintenance, and utilities management - Equipment qualification, calibration, and cleaning validation |
| Laboratory Systems | 14% | - Laboratory controls, calibration, and validation - Testing methods, data integrity, and result reporting |
| 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 |
| Filling, Packaging, and Labeling | 13% | - Packaging and labeling design and compliance - Filling operations, controls, and verification |
| Quality Systems | 18% | - Audits, corrective and preventive actions - Documentation, change control, and records management - Quality management system design and implementation |
| Manufacturing Systems | 16% | - Process design, validation, and control - Contamination control, cleaning, and hygiene - Sterile and non-sterile production requirements |
ASQ Certified Pharmaceutical GMP Professional Sample Questions:
1. The design and operation of water supply systems in pharmaceutical facilities must:
Response:
A) Be the most technologically advanced regardless of cost
B) Focus on creating a relaxing ambiance for employees
C) Ensure water quality through appropriate treatment and prevention measures
D) Feature customizable lighting and sound systems
2. Equipment used in packaging operations must be __________ and maintained.
Response:
A) outsourced
B) decorated
C) manually operated
D) qualified
3. Management review of the QMS is crucial for:
Response:
A) Tracking stock prices
B) Ensuring continuous improvement
C) Planning corporate events
D) Approving annual leave
4. The outcome of the laboratory portion of an investigation into atypical results should determine the _______ for further investigation.
Response:
A) budget
B) criteria
C) timeline
D) team members
5. Which means are effective in securing the supply chain?
(Choose two)
Response:
A) Implementing serialization and RFID technology
B) Relying solely on the trustworthiness of the shipping crew
C) Using tamper-evident seals
D) Choosing the cheapest shipping options available
Solutions:
| Question # 1 Answer: C | Question # 2 Answer: D | Question # 3 Answer: B | Question # 4 Answer: B | Question # 5 Answer: A,C |
