ASQ CPGP : Certified Pharmaceutical GMP Professional

  • Exam Code: CPGP
  • Exam Name: Certified Pharmaceutical GMP Professional
  • Updated: Aug 31, 2026     Q & A: 520 Questions and Answers

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ASQ CPGP Exam Syllabus Topics:

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

ASQ Certified Pharmaceutical GMP Professional Sample Questions:

Question 1

Calibration and engineering change control procedures are implemented to:
(Choose two)
Response:

A. Maintain the integrity of manufacturing processes
B. Facilitate the live streaming of equipment operations
C. Guarantee that modifications do not affect the precision and accuracy of measurements
D. Ensure equipment settings are optimized for the fastest production time


Question 2

Selecting appropriate raw materials involves __________ studies to evaluate their quality.
Response:

A. marketing
B. development
C. compatibility
D. financial


Question 3

Before a piece of equipment is used in production, which types of acceptance testing are typically conducted?
(Choose two)
Response:

A. Personal Acceptance Testing (PAT)
B. Factory Acceptance Testing (FAT)
C. Online Acceptance Testing (OAT)
D. Site Acceptance Testing (SAT)


Question 4

Which of these events typically triggers a CAPA in a quality management system?
Response:

A. An observed deviation from standard operating procedures
B. An annual review meeting
C. A successful product launch
D. A scheduled audit with no findings


Question 5

When an instrument is found to be out of calibration, the immediate step is to _______ before further use.
Response:

A. recalibrate the instrument
B. use the instrument for training purposes
C. continue using the instrument for non-critical tests
D. sell the instrument


Solutions:

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

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