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ASQ CPGP Exam Syllabus Topics:

SectionWeightObjectives
Production Systems23%-27%- Manufacturing operations
  • 1. Batch processing
  • 2. Contamination control
  • 3. Process validation
  • 4. Packaging and labeling
Materials Systems13%-17%- Material controls
  • 1. Storage and distribution
  • 2. Incoming material inspection
  • 3. Supplier qualification
  • 4. Inventory control
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
Laboratory Systems10%-14%- Laboratory operations
  • 1. Stability programs
  • 2. Analytical testing
  • 3. Data integrity
  • 4. Microbiology controls
Quality Management Systems22%-26%- Quality systems
  • 1. Documentation systems
  • 2. Quality culture
  • 3. Training systems
  • 4. GMP regulations and guidance
Packaging and Labeling Systems5%-9%- Packaging controls
  • 1. Tamper evidence
  • 2. Label issuance and reconciliation
  • 3. Packaging inspections

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ASQ Certified Pharmaceutical GMP Professional Sample Questions (Q75-Q80):

NEW QUESTION # 75
Why is it important to differentiate requirements for the sampling environment based on the type of material?
Response:

Answer: D


NEW QUESTION # 76
Different types of audits include:
(Choose two)
Response:

Answer: B,D


NEW QUESTION # 77
Vision and detection systems must be:
(Select two)
Response:

Answer: A,C


NEW QUESTION # 78
Contingency planning for automated systems is crucial to:
Response:

Answer: D


NEW QUESTION # 79
Weighing equipment in the dispensing process must be:
Response:

Answer: C


NEW QUESTION # 80
......

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