• Exam Code: CPGP
  • Exam Name: Certified Pharmaceutical GMP Professional
  • Certification Provider: ASQ
  • Corresponding Certification:ASQ Auditing
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CPGP
  • Exam Code: CPGP
  • Exam Name: Certified Pharmaceutical GMP Professional
  • Updated: Aug 19, 2026
  • No. of Questions: 520 Questions and Answers
  • Download Limit: Unlimited

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ASQ CPGP Exam Syllabus Topics:

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

ASQ Certified Pharmaceutical GMP Professional Sample Questions:

1. The FDA's regulations are crucial for pharmaceuticals in the USA. What does FDA stand for?
Response:

A) Federal Department of Agriculture
B) Food and Drug Administration
C) Federal Drug Agency
D) Food and Dietary Association


2. For temperature-sensitive products, what special requirements must be considered during shipping?
Response:

A) Shipping exclusively during winter months
B) Using packaging that changes color with temperature variations
C) Tertiary packaging and monitoring devices to ensure product integrity
D) Avoiding digital monitoring devices to reduce costs


3. Which of the following is NOT a reason to initiate a "stop shipment" for quality holds? Response:

A) Identification of quality issues
B) A surplus of inventory
C) Documentation discrepancies
D) Receipt of damaged materials


4. Effective change control practices for facilities are critical for:
Response:

A) Making the facility more attractive to potential employees
B) Allowing for rapid shifts in production based on market demand
C) Adapting to fashion trends in facility design
D) Ensuring that modifications do not compromise the facility's qualified state


5. When conducting a needs analysis, it is crucial to identify:
Response:

A) Potential investors
B) Product prices
C) Training requirements
D) Advertising channels


Solutions:

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

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