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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+)
      Production and Process Control- Manufacturing operations
      • 1. In-process controls and monitoring
        • 2. Process validation and control strategies
          Pharmaceutical Quality Systems- Quality system principles and implementation
          • 1. Continuous improvement and quality metrics
            • 2. Quality management system structure in pharma GMP environments
              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
                      Quality Control and Laboratory Systems- Testing and release systems
                      • 1. Batch release and specification compliance
                        • 2. Sampling and testing methodologies
                          Validation and Qualification- Validation lifecycle
                          • 1. Process and cleaning validation
                            • 2. Equipment qualification (IQ/OQ/PQ)

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                              ASQ Certified Pharmaceutical GMP Professional Sample Questions (Q237-Q242):

                              NEW QUESTION # 237
                              In evaluating packaging materials, which aspect is NOT typically considered a critical quality attribute?
                              Response:

                              Answer: A


                              NEW QUESTION # 238
                              Adverse event reporting is a key component of:
                              Response:

                              Answer: B


                              NEW QUESTION # 239
                              In managing outsourced processes, it is critical to:
                              Response:

                              Answer: B


                              NEW QUESTION # 240
                              Staff evaluations for manual and semi-automatic inspections ensure that:
                              Response:

                              Answer: B


                              NEW QUESTION # 241
                              What are essential aspects to verify during the Installation Qualification (IQ) of new manufacturing equipment?
                              (Choose two)
                              Response:

                              Answer: A,C


                              NEW QUESTION # 242
                              ......

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