ASQ CPGP : Certified Pharmaceutical GMP Professional

  • Exam Code: CPGP
  • Exam Name: Certified Pharmaceutical GMP Professional
  • Updated: Aug 06, 2026   Q&As: 520 Questions and Answers

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ASQ CPGP Exam Syllabus Topics:

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

ASQ Certified Pharmaceutical GMP Professional Sample Questions:

1. The Quality Management Maturity assessment is used to:
Response:

A) Validate financial investment decisions
B) Evaluate employee satisfaction
C) Check the effectiveness of marketing campaigns
D) Ensure the QMS evolves with the product and processes


2. When analyzing stability test data against specifications, it is important to:
Response:

A) Focus solely on the aesthetic aspects of the product
B) Identify trends that may affect the product's quality over time
C) Compare the results to competitor products
D) Determine the fastest way to complete the testing


3. Trend analysis in the context of CAPA is crucial for:
Response:

A) Designing new product lines
B) Predicting stock market trends
C) Identifying recurring or new issues
D) Planning social media campaigns


4. Which qualifications ensure that facilities, equipment, and utilities perform correctly under their operational range before being used in a manufacturing process?
(Choose two)
Response:

A) Initial Qualification (IQ)
B) Installation Qualification (IQ)
C) Performance Qualification (PQ)
D) Environmental Qualification (EQ)


5. A comprehensive approach to managing laboratory instruments includes classification, qualification, calibration, and _______.
Response:

A) preventive maintenance
B) disposal
C) neglect
D) random checks


Solutions:

Question # 1
Answer: D
Question # 2
Answer: B
Question # 3
Answer: C
Question # 4
Answer: B,C
Question # 5
Answer: A

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