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Last Updated: Aug 09, 2026

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ASQ CPGP Exam Syllabus Topics:

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

                              ASQ Certified Pharmaceutical GMP Professional Sample Questions:

                              1. Risk evaluation and mitigation strategy (REMS) is implemented to:
                              Response:

                              A) Reduce operational costs
                              B) Promote the drug more effectively
                              C) Enhance investor relations
                              D) Mitigate potential risks associated with a drug's use


                              2. Which documents are essential for demonstrating staff development and proficiency?
                              (Choose two)
                              Response:

                              A) Training certificates
                              B) Performance appraisals
                              C) Financial statements
                              D) Vacation records


                              3. In managing outsourced processes, it is critical to:
                              Response:

                              A) Define the roles and responsibilities of each party
                              B) Limit the communication with the contractor to reduce interference
                              C) Allow the contractor to operate independently without oversight
                              D) Focus solely on the cost-effectiveness of the outsourcing arrangement


                              4. Which of the following dosage forms may require specific utility requirements in manufacturing?
                              (Select three)
                              Response:

                              A) Solids
                              B) Liquids
                              C) Gases
                              D) Semisolids


                              5. Which of the following is an example of a critical quality attribute?
                              Response:

                              A) The font used on the product label
                              B) Sterility for injectable products
                              C) The product name
                              D) The color of the tablet coating


                              Solutions:

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

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