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Last Updated: Aug 02, 2026

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ASQ CPGP Exam Syllabus Topics:

SectionObjectives
Topic 1: Documentation and Data Integrity- GMP documentation practices
  • 1. Batch records and SOP control
    • 2. Data integrity principles (ALCOA+)
      Topic 2: GMP Regulations and Compliance- Inspection readiness
      • 1. Audit preparation and response
        • 2. Regulatory inspection process
          - Regulatory frameworks
          • 1. FDA cGMP requirements
            • 2. ICH guidelines overview
              Topic 3: Pharmaceutical Quality Systems- Quality system principles and implementation
              • 1. Continuous improvement and quality metrics
                • 2. Quality management system structure in pharma GMP environments
                  Topic 4: Quality Control and Laboratory Systems- Testing and release systems
                  • 1. Sampling and testing methodologies
                    • 2. Batch release and specification compliance
                      Topic 5: Validation and Qualification- Validation lifecycle
                      • 1. Process and cleaning validation
                        • 2. Equipment qualification (IQ/OQ/PQ)
                          Topic 6: Production and Process Control- Manufacturing operations
                          • 1. Process validation and control strategies
                            • 2. In-process controls and monitoring

                              ASQ Certified Pharmaceutical GMP Professional Sample Questions:

                              1. How can digital reporting benefit a pharmaceutical company during inspections?
                              Response:

                              A) By automatically marketing products during the inspection.
                              B) By reducing the need for employee training.
                              C) By eliminating the need for any future inspections.
                              D) By allowing real-time updates and transparency.


                              2. What type of data trends is typically analyzed in an Annual Product Review (APR)?
                              Response:

                              A) Environmental impact trends
                              B) Financial performance trends
                              C) Product quality and compliance trends
                              D) Consumer behavior trends


                              3. Why is it necessary to review and ensure the integrity of laboratory records, including electronic data's audit trails?
                              Response:

                              A) To detect errors, falsification, and fraud
                              B) To create space for new records
                              C) To prepare for potential legal actions
                              D) To comply with aesthetic record-keeping standards


                              4. When initiating an investigation for atypical results in a chemical test, which of the following is the first step?
                              Response:

                              A) Discarding the atypical results as errors
                              B) Adjusting the specification limits to accommodate the results
                              C) Re-testing using the same method
                              D) Reviewing the testing procedure and all associated records


                              5. What does REMS stand for in pharmaceutical surveillance?
                              Response:

                              A) Risk Evaluation and Management Strategy
                              B) Risk Evaluation and Mitigation Strategy
                              C) Regulatory Evaluation and Mitigation Scheme
                              D) Regulatory Evaluation and Management Scheme


                              Solutions:

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

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