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ASQ CPGP Exam Syllabus Topics:

SectionObjectives
Documentation and Data Integrity- GMP documentation practices
  • 1. Data integrity principles (ALCOA+)
    • 2. Batch records and SOP control
      Validation and Qualification- Validation lifecycle
      • 1. Process and cleaning validation
        • 2. Equipment qualification (IQ/OQ/PQ)
          GMP Regulations and Compliance- Inspection readiness
          • 1. Audit preparation and response
            • 2. Regulatory inspection process
              - Regulatory frameworks
              • 1. ICH guidelines overview
                • 2. FDA cGMP requirements
                  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. 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

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                              ASQ Certified Pharmaceutical GMP Professional Sample Questions (Q35-Q40):

                              NEW QUESTION # 35
                              Which is the most appropriate disposal method for rejected raw materials?

                              Answer: B


                              NEW QUESTION # 36
                              Process Analytical Technology (PAT) tools include:
                              (Select three)
                              Response:

                              Answer: A,B,C


                              NEW QUESTION # 37
                              Which of the following best describes the intention behind post-marketing changes assessment?
                              Response:

                              Answer: A


                              NEW QUESTION # 38
                              Which qualifications ensure that facilities, equipment, and utilities perform correctly under their operational range before being used in a manufacturing process?
                              (Choose two)
                              Response:

                              Answer: B,D


                              NEW QUESTION # 39
                              The Quality Management Maturity assessment is used to:
                              Response:

                              Answer: C


                              NEW QUESTION # 40
                              ......

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