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Certified Pharmaceutical GMP Professional — Information & Free Practice

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Certified Pharmaceutical GMP Professional

Provider
Prometric
Format
One-part, English-only, open-book multiple-choice examination; the selected window uses computer-based testing. Paper delivery has the same scored content scope.
Exam questions
Total questions: 165; Scored questions: 150; Unscored questions: 15; The total includes the scored and unscored questions.
Time limit
CBT exam time: 4 hours 18 minutes; appointment: 4 hours 30 minutes. Paper exam: 4 hours.
Examination outline
  • Regulatory Agency Governance (11.33%)
    • Global regulatory framework
    • Regulations and guidances
    • Mutual recognition agreements
    • Regulatory inspections
    • Enforcement actions
    • Regulatory agency reporting
    • Site Master File (SMF), Validation Master Plan (VMP), Drug Master File (DMF), and Site Reference File (SRF)
  • Quality Systems (17.33%)
    • Quality management system (QMS)
    • Quality unit (site) management
    • Risk management and assessment
    • Training and personnel qualification
    • Change control and management
    • Investigations and corrective and preventive action (CAPA)
    • Audits and self-inspections
    • Documents and records management
    • Product complaints and adverse event reports
    • Product trend requirements
    • Supplier and contractor quality management
  • Laboratory Systems (13.33%)
    • Compendia (United States, Europe, and Japan)
    • Laboratory investigations of atypical results
    • Instrument management
    • Specifications
    • Laboratory record-keeping and data requirements
    • Laboratory handling controls
    • Stability programs
    • Reserve samples and retains
  • Infrastructure: Facilities, Utilities, and Equipment (11.33%)
    • Facilities
    • Utilities
    • Equipment
    • Qualification and validation
    • Maintenance and metrology systems
    • General cleaning, sanitization, and sterilization systems
    • Automated or computerized systems
    • Business continuity and disaster recovery planning
  • Materials and Supply Chain Management (11.33%)
    • Receipt of materials
    • Sampling processes
    • Material storage, identification, and rotation
    • Shipping and distribution
    • Traceability and sourcing
    • Salvaged/returned goods and destruction
  • Sterile and Nonsterile Manufacturing Systems (14.67%)
    • Master batch and completed batch records
    • Production operations
    • In-process controls
    • Dispensing and weighing controls
    • Requirements for critical unit processes
    • Contamination and cross-contamination
    • Reprocessed and reworked materials
  • Filling, Packaging, and Labeling (12%)
    • Filling operations and controls
    • Environmental monitoring
    • In-process and finished goods inspections
    • Product inspection
    • Packaging operations and controls
    • Labeling operations and controls
    • Filling and packaging records
  • Product Development and Technology Transfer (8.67%)
    • Quality by design concepts
    • Phase-appropriate Good Manufacturing Practices (GMP) requirements
    • Raw materials, packaging, and infrastructure for product development
    • New product development studies and reports
    • Scale-up and transfer activities
Examination sources

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