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ASQ CPGP Exam Syllabus Topics:

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

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ASQ Certified Pharmaceutical GMP Professional Sample Questions (Q426-Q431):

NEW QUESTION # 426
Which of the following is a purpose of monitoring critical process parameters (CPPs)?
Response:

Answer: A


NEW QUESTION # 427
Master batch records are essential because they:
Response:

Answer: A


NEW QUESTION # 428
What is the main purpose of materials control in filling operations?
Response:

Answer: D


NEW QUESTION # 429
Evidence of line clearance must be __________.
Response:

Answer: B


NEW QUESTION # 430
The layout of equipment in a pharmaceutical manufacturing facility should:Response:

Answer: A


NEW QUESTION # 431
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