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ASQ CPGP Exam Syllabus Topics:

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

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                              ASQ Certified Pharmaceutical GMP Professional Sample Questions (Q482-Q487):

                              NEW QUESTION # 482
                              The use of PAT tools in manufacturing supports:
                              Response:

                              Answer: B


                              NEW QUESTION # 483
                              How often are European Product Quality Reviews (PQRs) typically conducted?
                              Response:

                              Answer: C


                              NEW QUESTION # 484
                              Needs analysis in training and personnel qualification is essential for determining:
                              Response:

                              Answer: A


                              NEW QUESTION # 485
                              Which of the following is a purpose of monitoring critical process parameters (CPPs)?
                              Response:

                              Answer: B


                              NEW QUESTION # 486
                              Which of the following should be assessed during an impact assessment?
                              (Choose two)
                              Response:

                              Answer: A,B


                              NEW QUESTION # 487
                              ......

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