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ASQ CPGP Exam Syllabus Topics:
| Section | Weight | Objectives |
| Regulatory Agency Governance | 12% | - Global regulatory framework and requirements
- Inspection, enforcement, and compliance processes
|
| Quality Systems | 18% | - Documentation, change control, and records management
- Quality management system design and implementation
- Audits, corrective and preventive actions
|
| Infrastructure and Facilities | 12% | - Facility design, maintenance, and utilities management
- Equipment qualification, calibration, and cleaning validation
|
| Filling, Packaging, and Labeling | 13% | - Packaging and labeling design and compliance
- Filling operations, controls, and verification
|
| Manufacturing Systems | 16% | - Process design, validation, and control
- Sterile and non-sterile production requirements
- Contamination control, cleaning, and hygiene
|
| Product Development and Technology Transfer | 9% | - Product lifecycle management and regulatory submissions
- Technology transfer, scale-up, and validation
|
| Materials and Supply Chain Management | 12% | - Inventory control, traceability, and distribution practices
- Supplier qualification, material receipt, and storage
|
| Laboratory Systems | 14% | - Laboratory controls, calibration, and validation
- Testing methods, data integrity, and result reporting
|
ASQ Certified Pharmaceutical GMP Professional Sample Questions:
1. Formal contracts or quality agreements with suppliers should include provisions for:
(Choose two)
Response:
A) Regular social events to maintain a good working relationship
B) Flexible payment terms based on the buyer's financial condition
C) Audit and inspection rights
D) Continuous improvement and corrective action procedures
2. To minimize the risk of contamination and cross-contamination, it is essential to:
Response:
A) Implement proper cleaning procedures
B) Ignore personnel flow patterns
C) Increase the speed of production
D) Use unqualified disinfectants
3. A pre-approval inspection in the pharmaceutical industry is conducted to:
Response:
A) Evaluate the overall financial health of the manufacturing firm.
B) Confirm the effectiveness of a new marketing strategy.
C) Assess the manufacturing site's compliance with regulatory standards before product approval.
D) Investigate a specific complaint or adverse event.
4. EU GMP guidelines are essential to ensure product quality and _____.Response:
A) availability
B) affordability
C) safety
D) innovation
5. How should inventory transactions be documented to maintain effective inventory controls?
Response:
A) By memorizing transactions
B) Using a formal, documented process to update inventory records
C) Informally, based on staff availability
D) On social media platforms for transparency
Solutions:
Question # 1 Answer: C,D | Question # 2 Answer: A | Question # 3 Answer: C | Question # 4 Answer: C | Question # 5 Answer: B |