OpenExamsFREE PRACTICE — ANY EXAM

Certified Pharmaceutical GMP Professional — Requirements & Free Practice

US · License preparation

100 free questions · Answer explanations · No signup required

Choose what to practice

Start with an exam below. Your examination requirements depend on your application pathway. View licensing requirements

Loading selected examination banks…

Licenses, application pathways and examination requirements

Each license and applicant pathway has its own requirements and exemptions. Choosing practice questions does not determine your eligibility.

Certified Pharmaceutical GMP Professional

Professional certification of pharmaceutical good manufacturing practice knowledge; ASQE certification is not a license or registration.

Licensing authority: ASQExcellence (ASQE)

Initial by examination
Certified Pharmaceutical GMP Professional
Application
Application approval precedes scheduling with Prometric in the selected testing window. Certification also requires proof of professionalism; the application checklist requires reading and agreeing to the ASQE Testing Agreement and ASQ Code of Ethics.
Date Applicability
Current official program and linked current BoK support evaluation on 2026-10-24; no unpublished official effective date is inferred.
Decision Making
Authority to define, execute, or control projects/processes and be responsible for the outcome; management or supervisory status is not required.
Education
No education waivers.
Experience
Five years of on-the-job experience in one or more CPGP BoK areas, including at least three years in a decision-making position, in a full-time paid role.
Selected Testing Window
{"applicationDeadline":"2026-11-09","end":"2026-12-31","start":"2026-12-01"}

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