ASQ Certified Pharmaceutical GMP Professional : CPGP

  • Exam Code: CPGP
  • Exam Name: Certified Pharmaceutical GMP Professional
  • Updated: Sep 11, 2026     Q & A: 520 Questions and Answers

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ASQ CPGP Exam Syllabus Topics:

SectionWeightObjectives
Topic 1: Regulatory Agency Governance12%- Inspection, enforcement, and compliance processes
- Global regulatory framework and requirements
Topic 2: Product Development and Technology Transfer9%- Technology transfer, scale-up, and validation
- Product lifecycle management and regulatory submissions
Topic 3: Materials and Supply Chain Management12%- Inventory control, traceability, and distribution practices
- Supplier qualification, material receipt, and storage
Topic 4: Manufacturing Systems16%- Contamination control, cleaning, and hygiene
- Process design, validation, and control
- Sterile and non-sterile production requirements
Topic 5: Laboratory Systems14%- Testing methods, data integrity, and result reporting
- Laboratory controls, calibration, and validation
Topic 6: Quality Systems18%- Documentation, change control, and records management
- Audits, corrective and preventive actions
- Quality management system design and implementation
Topic 7: Infrastructure and Facilities12%- Equipment qualification, calibration, and cleaning validation
- Facility design, maintenance, and utilities management
Topic 8: Filling, Packaging, and Labeling13%- Filling operations, controls, and verification
- Packaging and labeling design and compliance

ASQ Certified Pharmaceutical GMP Professional Sample Questions:

Question #1

Environmental conditions such as temperature and humidity are controlled during the storage of materials to:
Response:

  • A. Make the materials easier to transport
  • B. Maintain the materials' characteristics and ensure accurate testing results
  • C. Prevent unauthorized access to the materials
  • D. Reduce the volume of materials stored
Answer: B
Question #2

Effective change implementation requires:
Response:

  • A. A specific and actionable change implementation plan
  • B. Immediate execution without a detailed plan
  • C. Minimal documentation for speed
  • D. Approval from all stakeholders
Answer: A
Question #3

The main goal of environmental monitoring during scale-up is to:
Response:

  • A. Assess customer satisfaction
  • B. Ensure regulatory compliance
  • C. Track stock market trends
  • D. Monitor employee performance
Answer: B
Question #4

Which ISO standard is commonly referenced in the context of pharmaceutical quality management?
Response:

  • A. ISO 9001
  • B. ISO 14001
Answer: A
Question #5

Batch records must be reviewed for certain required elements. Which of the following is NOT one of these elements?
Response:

  • A. Critical manufacturing step verification
  • B. Employee vacation schedules
  • C. Proper issuance
  • D. Sections on yields
Answer: B

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