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ASQ CPGP Exam Syllabus Topics:

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

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ASQ Certified Pharmaceutical GMP Professional Sample Questions (Q361-Q366):

NEW QUESTION # 361
What action is crucial when receiving materials from unapproved suppliers?
Response:

Answer: B


NEW QUESTION # 362
When evaluating the adequacy of supplier controls, it is essential to assess:
Response:

Answer: D


NEW QUESTION # 363
Which of the following are valid environmental monitoring tools?
(Select two)
Response:

Answer: A,D


NEW QUESTION # 364
Effective risk mitigation for contamination includes __________; facility, utility, and equipment design; and operator training.
Response:

Answer: D


NEW QUESTION # 365
The Site Master File (SMF) should contain information about:
Response:

Answer: A


NEW QUESTION # 366
......

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