ASQ CPGP : Certified Pharmaceutical GMP Professional

  • Exam Code: CPGP
  • Exam Name: Certified Pharmaceutical GMP Professional
  • Updated: Sep 15, 2026
  • Q & A: 520 Questions and Answers

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ASQ CPGP Exam Syllabus Topics:

SectionWeightObjectives
Topic 1: Packaging and Labeling Systems5%-9%- Packaging controls
  • 1. Tamper evidence
  • 2. Packaging inspections
  • 3. Label issuance and reconciliation
Topic 2: Materials Systems13%-17%- Material controls
  • 1. Incoming material inspection
  • 2. Storage and distribution
  • 3. Inventory control
  • 4. Supplier qualification
Topic 3: Facilities and Equipment Systems18%-22%- Equipment
  • 1. Calibration and maintenance
  • 2. Qualification and validation
  • 3. Equipment cleaning
- Facilities
  • 1. Facility design and maintenance
  • 2. Cleaning and sanitation
  • 3. Utilities and environmental controls
Topic 4: Production Systems23%-27%- Manufacturing operations
  • 1. Process validation
  • 2. Contamination control
  • 3. Batch processing
  • 4. Packaging and labeling
Topic 5: Laboratory Systems10%-14%- Laboratory operations
  • 1. Data integrity
  • 2. Analytical testing
  • 3. Microbiology controls
  • 4. Stability programs
Topic 6: Quality Management Systems22%-26%- Quality systems
  • 1. GMP regulations and guidance
  • 2. Quality culture
  • 3. Documentation systems
  • 4. Training systems

ASQ Certified Pharmaceutical GMP Professional Sample Questions:

Question #1

Equipment planning in a pharmaceutical facility involves considering:
Response:

  • A. The brand of equipment for marketing purposes
  • B. The color scheme of equipment to match the facility's interior
  • C. The potential for equipment to be used as office furniture
  • D. Location, design, and maintenance based on operations
Reveal Solution  Discussion  0

Correct Answer: D  🗳️

Question #2

Before a piece of equipment is used in production, which types of acceptance testing are typically conducted?
(Choose two)
Response:

  • A. Site Acceptance Testing (SAT)
  • B. Online Acceptance Testing (OAT)
  • C. Factory Acceptance Testing (FAT)
  • D. Personal Acceptance Testing (PAT)
Reveal Solution  Discussion  0

Correct Answer: A,C  🗳️

Question #3

For marketing authorization, the relationship between the USP, EP, and JP is best described as:
Response:

  • A. Mutually exclusive.
  • B. Identical across all regions.
  • C. Region-specific requirements.
  • D. Interchangeable.
Reveal Solution  Discussion  0

Correct Answer: C  🗳️

Question #4

A process audit focuses on:
Response:

  • A. The company's market share
  • B. The overall financial health of a company
  • C. The effectiveness and efficiency of a process
  • D. The quality of the end product
Reveal Solution  Discussion  0

Correct Answer: C  🗳️

Question #5

The main difference between release tests and stability-indicating tests is that stability-indicating tests:
Response:

  • A. Are not required for regulatory compliance
  • B. Are only performed once at the time of release
  • C. Provide information on how the quality of a product changes over time
  • D. Focus exclusively on the product's appearance
Reveal Solution  Discussion  0

Correct Answer: C  🗳️

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