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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+)
      Quality Control and Laboratory Systems- Testing and release systems
      • 1. Sampling and testing methodologies
        • 2. Batch release and specification compliance
          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. Quality management system structure in pharma GMP environments
                • 2. Continuous improvement and quality metrics
                  GMP Regulations and Compliance- Inspection readiness
                  • 1. Regulatory inspection process
                    • 2. Audit preparation and response
                      - Regulatory frameworks
                      • 1. FDA cGMP requirements
                        • 2. ICH guidelines overview
                          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 (Q366-Q371):

                              NEW QUESTION # 366
                              The impact analysis for a proposed change should NOT:
                              Response:

                              Answer: D


                              NEW QUESTION # 367
                              Specification limits are assessed in relation to:
                              Response:

                              Answer: A


                              NEW QUESTION # 368
                              Batch release for commercial products requires rigorous _____ to ensure compliance with quality standards.
                              Response:

                              Answer: C


                              NEW QUESTION # 369
                              The role of a Qualified Person includes ensuring:
                              Response:

                              Answer: D


                              NEW QUESTION # 370
                              What are the goals of a metrology program in pharmaceutical manufacturing?
                              (Choose two)
                              Response:

                              Answer: B,C


                              NEW QUESTION # 371
                              ......

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