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ASQ CPGP Exam Syllabus Topics:

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

ASQ Certified Pharmaceutical GMP Professional Sample Questions:

1. A design space is established to:
Response:

A) Provide a framework within which changes can be made without further regulatory approval
B) Limit creativity in product development
C) Simplify documentation requirements
D) Encourage a trial-and-error approach to manufacturing


2. Development criteria for in-process inspections should include:
Response:

A) Marketing feedback loops
B) Seal tests
C) Packaging aesthetics
D) Color preference surveys


3. A comprehensive supplier evaluation process should include which of the following methodologies?
(Choose two)
Response:

A) Pricing comparisons only
B) Personal relationships with vendors
C) Supplied product or service performance trending
D) Supplier certification


4. The process of instrument qualification is important because it:
Response:

A) Determines that an instrument is suitable for its intended purpose
B) Ensures that the instrument is the latest model
C) Guarantees that the instrument will never need recalibration
D) Allows for the use of the instrument by any laboratory staff


5. Which of the following are valid environmental monitoring tools?
(Select two)
Response:

A) Employee satisfaction surveys
B) Nonviable particulate measuring instruments
C) Financial performance tracking software
D) Viable particulate measuring instruments


Solutions:

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

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