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ASQ CPGP Exam Syllabus Topics:

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

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                              ASQ Certified Pharmaceutical GMP Professional Sample Questions (Q345-Q350):

                              NEW QUESTION # 345
                              ICH Q12 provides guidance on:
                              Response:

                              Answer: D


                              NEW QUESTION # 346
                              The evaluation of supplier quality systems is important to:
                              Response:

                              Answer: B


                              NEW QUESTION # 347
                              In relation to combination products, the studies required to meet GMP requirements often include:
                              Response:

                              Answer: C


                              NEW QUESTION # 348
                              Audit follow-up actions are necessary to:Response:

                              Answer: B


                              NEW QUESTION # 349
                              For a manufacturing facility, the hold times in the batch records are important to:
                              Response:

                              Answer: D


                              NEW QUESTION # 350
                              ......

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