ASQ Certified Pharmaceutical GMP Professional : CPGP

  • Exam Code: CPGP
  • Exam Name: Certified Pharmaceutical GMP Professional
  • Updated: Aug 30, 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: Laboratory Systems10%-14%- Laboratory operations
  • 1. Stability programs
  • 2. Data integrity
  • 3. Microbiology controls
  • 4. Analytical testing
Topic 3: Facilities and Equipment Systems18%-22%- Facilities
  • 1. Facility design and maintenance
  • 2. Utilities and environmental controls
  • 3. Cleaning and sanitation
- Equipment
  • 1. Equipment cleaning
  • 2. Calibration and maintenance
  • 3. Qualification and validation
Topic 4: Production Systems23%-27%- Manufacturing operations
  • 1. Batch processing
  • 2. Packaging and labeling
  • 3. Contamination control
  • 4. Process validation
Topic 5: Materials Systems13%-17%- Material controls
  • 1. Incoming material inspection
  • 2. Inventory control
  • 3. Supplier qualification
  • 4. Storage and distribution
Topic 6: Quality Management Systems22%-26%- Quality systems
  • 1. Quality culture
  • 2. GMP regulations and guidance
  • 3. Training systems
  • 4. Documentation systems

ASQ Certified Pharmaceutical GMP Professional Sample Questions:

Question 1

The Japanese Pharmacopoeia (JP) is primarily required for marketing authorization in:
Response:

A. All countries worldwide
B. Europe
C. The United States
D. Japan


Question 2

How does identifying a stability-point failure in a product impact its regulatory status?
Response:

A. It may necessitate a review and possible action to maintain compliance
B. It results in an immediate increase in the product's market value
C. It has no impact on regulatory compliance
D. It automatically leads to the product being banned


Question 3

Sanitization procedures for pharmaceutical facilities must:
Response:

A. Be chosen based on the lowest cost
B. Be in accordance with validation studies
C. Prioritize the use of aesthetically pleasing sanitizers
D. Focus solely on areas visible to visitors


Question 4

Which organization issues the Pharmaceutical Inspection Convention/Scheme guidance?

A. ISPE
B. WHO
C. FDA
D. PIC/S


Question 5

Reviewing compendial or non-compendial requirements is critical for ensuring:(Choose two) Response:

A. Procedures are in place for both qualification and validation.
B. The laboratory's social media presence is enhanced.
C. Tests are chosen based on the laboratory's location.
D. Test methods are aligned with required compendial chapters.


Solutions:

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

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