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ASQ CPGP Exam Syllabus Topics:
| Section | Weight | Objectives |
|---|---|---|
| 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 |
| 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% | - Inventory control, traceability, and distribution practices - Supplier qualification, material receipt, and storage |
| Regulatory Agency Governance | 12% | - Inspection, enforcement, and compliance processes - Global regulatory framework and requirements |
| 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 |
ASQ Certified Pharmaceutical GMP Professional Sample Questions:
1. Health Canada is the federal department responsible for helping Canadians maintain and improve their health. In which country does it operate?
Response:
A) Canada
B) United States
C) Australia
D) United Kingdom
2. What is the goal of product surveillance in the pharmaceutical industry?
Response:
A) To gather data for marketing analysis
B) To ensure continuous patient safety and product efficacy
C) To monitor competitive product launches
D) To track the movement of pharmaceutical stocks
3. For a manufacturing facility, the hold times in the batch records are important to:
Response:
A) Schedule employee vacations
B) Determine the lunch break length
C) Plan marketing campaigns
D) Ensure stability and prevent degradation of the product
4. Variations to dossiers and applications are made to:
Response:
A) Announce new executive hires
B) Reflect changes in the product or its manufacturing process
C) Update the company's contact information
D) Announce new executive hires
5. Immediate actions in response to a trigger event should aim to:
Response:
A) Assign blame to responsible parties
B) Immediately resolve the underlying issue without investigation
C) Contain any potential impact
D) Eliminate the need for further action
Solutions:
| Question # 1 Answer: A | Question # 2 Answer: B | Question # 3 Answer: D | Question # 4 Answer: B | Question # 5 Answer: C |
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