ASQ CPGP Exam : Certified Pharmaceutical GMP Professional

  • Exam Code: CPGP
  • Exam Name: Certified Pharmaceutical GMP Professional
  • Updated: Aug 29, 2026
  • Q & A: 520 Questions and Answers

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ASQ CPGP Exam Syllabus Topics:

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

                              ASQ Certified Pharmaceutical GMP Professional Sample Questions:

                              Question 1

                              The use of PAT tools in manufacturing supports:
                              Response:

                              A. The manufacture of quality products
                              B. Increased downtime
                              C. Decreased product quality
                              D. Reduced understanding of processes


                              Question 2

                              ICH Q10 integrates elements of _____ and continual improvement into the quality management system.
                              Response:

                              A. profit maximization
                              B. competitive analysis
                              C. product lifecycle
                              D. investor relations


                              Question 3

                              The traceability of finished drugs allows for the ___________ of any quality issues back through the supply chain.
                              Response:

                              A. Promotion
                              B. Ignoring
                              C. Investigation
                              D. Marketing


                              Question 4

                              The purpose of a Site Reference File (SRF) includes:
                              Response:

                              A. Listing the cafeteria menu options
                              B. Presenting the site's annual holiday schedule
                              C. Advertising the site for potential investors
                              D. Describing the specifics of a site to inform regulatory inspections


                              Question 5

                              Field alert reports are critical for:
                              Response:

                              A. Notifying regulatory authorities of significant quality issues with distributed products
                              B. Announcing new product releases
                              C. Reporting internal staff changes
                              D. Informing shareholders about financial status


                              Solutions:

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

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