ASQ CPGP : Certified Pharmaceutical GMP Professional

  • Exam Code: CPGP
  • Exam Name: Certified Pharmaceutical GMP Professional
  • Updated: Sep 04, 2026     Q & A: 520 Questions and Answers

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ASQ CPGP Exam Syllabus Topics:

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

ASQ Certified Pharmaceutical GMP Professional Sample Questions:

Question 1

The assessment of staging areas is to ensure:
Response:

A. The comfort of visiting company executives
B. The most efficient use of space for office furniture
C. Adequate lighting for product photography
D. They meet requirements for process control and safety


Question 2

What are essential elements to review in Certificates of Analysis (COAs)?
(Choose two)
Response:

A. Color of the product
B. Completeness and internal review
C. Marketing claims
D. Appropriate retention and accessibility


Question 3

Essential components of successful technology transfer include:
(Select four)
Response:

A. In-process control studies
B. Hold times and shipping conditions studies
C. Capability studies
D. Ranging studies
E. Celebrity endorsements


Question 4

Destruction of unsuitable materials must be carried out in ___________ that comply with environmental and safety regulations.
Response:

A. Social media platforms
B. Designated facilities
C. Any available open space
D. Marketing departments


Question 5

Laboratory record-keeping and data requirements are designed to:
Response:

A. Simplify the job of laboratory personnel
B. Increase the workload for quality control departments
C. Make audits more challenging
D. Ensure the reproducibility and traceability of test results


Solutions:

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

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