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ASQ ASQ Auditing CPGP

CPGP

Exam Code: CPGP

Exam Name: Certified Pharmaceutical GMP Professional

Updated: Aug 05, 2026

Q & A: 520 Questions and Answers

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ASQ CPGP Exam Syllabus Topics:

SectionWeightObjectives
Quality Management Systems22%-26%- Quality systems
  • 1. Documentation systems
  • 2. Quality culture
  • 3. Training systems
  • 4. GMP regulations and guidance
Production Systems23%-27%- Manufacturing operations
  • 1. Process validation
  • 2. Batch processing
  • 3. Packaging and labeling
  • 4. Contamination control
Materials Systems13%-17%- Material controls
  • 1. Supplier qualification
  • 2. Inventory control
  • 3. Incoming material inspection
  • 4. Storage and distribution
Laboratory Systems10%-14%- Laboratory operations
  • 1. Analytical testing
  • 2. Microbiology controls
  • 3. Data integrity
  • 4. Stability programs
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. Qualification and validation
  • 3. Equipment cleaning
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. Remote audits are particularly useful when:Response:

A) In-person travel is restricted
B) Auditors prefer not to travel
C) The organization is too large for in-person audits
D) The weather conditions are unfavorable


2. Line clearance operations must be:Response:

A) Skipped to save time
B) Performed and documented
C) Optional based on production schedules
D) Conducted biannually


3. Staged materials must be:
Response:

A) Discounted for quick sale
B) Tested daily
C) Stored indefinitely
D) Approved for use


4. Validation studies for aseptic processing must include:
Response:

A) Taste testing
B) Process simulations (media fills)
C) Annual sales forecasts
D) Temperature controls


5. Which of the following statements is true about marketing requirements and compendia?
Response:

A) The EP is a requirement for marketing authorization within European countries.
B) Marketing authorization in Japan does not require compliance with any pharmacopoeia.
C) Marketing authorization in Europe requires compliance with the JP.
D) The USP is the only compendium recognized worldwide.


Solutions:

Question # 1
Answer: A
Question # 2
Answer: B
Question # 3
Answer: D
Question # 4
Answer: B,D
Question # 5
Answer: A

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