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ASQ CPGP Exam Syllabus Topics:

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

ASQ Certified Pharmaceutical GMP Professional Sample Questions:

Question #1

What is the primary purpose of the U.S. Annual Product Review (APR)? Response:

  • A. To analyze the marketing strategies for a product
  • B. To assess the financial performance of a product
  • C. To determine the product's popularity among consumers
  • D. To evaluate the compliance and quality performance of a product annually
Reveal Solution  Discussion  0

Correct Answer: D  🗳️

Question #2

What is essential for ensuring the storage environment is suitable for the type of materials stored?
Response:

  • A. Decorating storage areas to boost employee morale
  • B. Using the same storage conditions for all types of materials
  • C. Ensuring the environment is controlled and monitored as required
  • D. Color-coding storage areas based on aesthetics
Reveal Solution  Discussion  0

Correct Answer: C  🗳️

Question #3

What factor is least important when determining the suitability of a storage environment for pharmaceutical materials?
Response:

  • A. Temperature and humidity control
  • B. Monitoring and control systems
  • C. Protection from contamination
  • D. The cost of the storage facility
Reveal Solution  Discussion  0

Correct Answer: D  🗳️

Question #4

Product recalls are significant because they:
Response:

  • A. Affect the annual holiday party planning
  • B. Provide data for marketing strategies
  • C. Indicate a need to reassess product design and safety
  • D. Influence the company's stock prices
Reveal Solution  Discussion  0

Correct Answer: C  🗳️

Question #5

Which ICH guideline focuses on Quality Risk Management?
Response:

  • A. ICH Q9
  • B. ICH Q10
  • C. ICH Q12
  • D. ICH Q11
Reveal Solution  Discussion  0

Correct Answer: A  🗳️

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