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ASQ CPGP Exam Syllabus Topics:

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

                              ASQ Certified Pharmaceutical GMP Professional Sample Questions:

                              1. The main reason for ensuring equipment failure detection is to:
                              Response:

                              A) Reduce the need for employee training
                              B) Prevent potential product contamination and defects
                              C) Minimize energy usage
                              D) Enhance operator satisfaction


                              2. For tablet granulation and compression, critical process parameters include:
                              Response:

                              A) Color of the granules
                              B) Preferences of the production team
                              C) Granule size and compression force
                              D) Social media trends


                              3. The main difference between retest dates and expiration dates is that:
                              Response:

                              A) Expiration dates suggest when to start using a product.
                              B) There is no significant difference; both are chosen arbitrarily.
                              C) Retest dates are used for marketing purposes.
                              D) Retest dates require the material to be checked for continued compliance; expiration dates signal the end of a product's usable life.


                              4. Seal tests are developed to inspect __________ of filled and packaged materials.
                              Response:

                              A) weight
                              B) integrity
                              C) color consistency
                              D) price tags


                              5. Which of the following is a main element of a quality agreement?
                              Response:

                              A) Vendor's annual sales targets
                              B) Dispute resolution procedures
                              C) Financial penalties for contract termination
                              D) Marketing strategies for product launch


                              Solutions:

                              Question # 1
                              Answer: B
                              Question # 2
                              Answer: C
                              Question # 3
                              Answer: D
                              Question # 4
                              Answer: B
                              Question # 5
                              Answer: B

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