ASQ Certified Pharmaceutical GMP Professional : CPGP Exam

  • Exam Code: CPGP
  • Exam Name: Certified Pharmaceutical GMP Professional
  • Updated: Aug 07, 2026
  • Q & A: 520 Questions and Answers

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ASQ CPGP Exam Syllabus Topics:

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

ASQ Certified Pharmaceutical GMP Professional Sample Questions:

1. A key element of QMS structure includes:
Response:

A) Political affiliations
B) Organizational culture
C) Social media presence
D) Celebrity endorsements


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

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


3. Critical Quality Attributes (CQAs) are:
Response:

A) Characteristics that must be controlled within predefined limits
B) Unrelated to product safety and efficacy
C) Only related to product packaging
D) Arbitrary product characteristics


4. What is a critical consideration when designing a sampling plan for bulk chemicals?
Response:

A) The representative nature of the sample and appropriate sample size
B) The preferences of the production department
C) The color of the chemicals
D) The current stock price of the chemicals


5. What is the primary objective of regulatory reporting in the pharmaceutical industry?
Response:

A) To enhance marketing campaigns
B) To initiate product recalls
C) To monitor stock levels
D) To ensure transparency and accountability


Solutions:

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

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