ASQ CPGP Exam : Certified Pharmaceutical GMP Professional

CPGP
  • Exam Code: CPGP
  • Exam Name: Certified Pharmaceutical GMP Professional
  • Updated: Sep 17, 2026
  • Q & A: 520 Questions and Answers

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ASQ CPGP Exam Syllabus Topics:

SectionObjectives
Documentation and Data Integrity- GMP documentation practices
  • 1. Batch records and SOP control
    • 2. Data integrity principles (ALCOA+)
      Validation and Qualification- Validation lifecycle
      • 1. Equipment qualification (IQ/OQ/PQ)
        • 2. Process and cleaning validation
          Production and Process Control- Manufacturing operations
          • 1. In-process controls and monitoring
            • 2. Process validation and control strategies
              GMP Regulations and Compliance- Regulatory frameworks
              • 1. FDA cGMP requirements
                • 2. ICH guidelines overview
                  - Inspection readiness
                  • 1. Regulatory inspection process
                    • 2. Audit preparation and response
                      Quality Control and Laboratory Systems- Testing and release systems
                      • 1. Sampling and testing methodologies
                        • 2. Batch release and specification compliance
                          Pharmaceutical Quality Systems- Quality system principles and implementation
                          • 1. Continuous improvement and quality metrics
                            • 2. Quality management system structure in pharma GMP environments

                              ASQ Certified Pharmaceutical GMP Professional Sample Questions:

                              Question #1

                              What is the primary purpose of the U.S. Annual Product Review (APR)? Response:

                              • A. To analyze the marketing strategies for a product
                              • B. To assess the financial performance of a product
                              • C. To evaluate the compliance and quality performance of a product annually
                              • D. To determine the product's popularity among consumers
                              Reveal Solution  Discussion  0

                              Correct Answer: C  🗳️

                              Question #2

                              Which compendium is a requirement for marketing authorization in the United States?
                              Response:

                              • A. European Pharmacopoeia (EP)
                              • B. Japanese Pharmacopoeia (JP)
                              • C. All of the above
                              • D. United States Pharmacopoeia (USP)
                              Reveal Solution  Discussion  0

                              Correct Answer: D  🗳️

                              Question #3

                              What is the main purpose of assessing post-marketing changes in pharmaceuticals?
                              Response:

                              • A. To update marketing strategies
                              • B. To adjust the product's market price
                              • C. To evaluate their impact on safety and efficacy
                              • D. To redesign the product packaging
                              Reveal Solution  Discussion  0

                              Correct Answer: C  🗳️

                              Question #4

                              The main difference between systems and process audits is that systems audits evaluate:
                              Response:

                              • A. Individual employee performance
                              • B. The end product quality
                              • C. The entire quality system
                              • D. The process efficiency only
                              Reveal Solution  Discussion  0

                              Correct Answer: C  🗳️

                              Question #5

                              Reviewing compendial or non-compendial requirements is critical for ensuring:(Choose two) Response:

                              • A. Tests are chosen based on the laboratory's location.
                              • B. The laboratory's social media presence is enhanced.
                              • C. Procedures are in place for both qualification and validation.
                              • D. Test methods are aligned with required compendial chapters.
                              Reveal Solution  Discussion  0

                              Correct Answer: C,D  🗳️

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