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ASQ CPGP Exam Syllabus Topics:

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

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ASQ Certified Pharmaceutical GMP Professional Sample Questions (Q250-Q255):

NEW QUESTION # 250
Which of the following are valid environmental monitoring tools?
(Select two)
Response:

Answer: C,D


NEW QUESTION # 251
In the context of pharmacovigilance, the primary focus is on:
Response:

Answer: B


NEW QUESTION # 252
Specification limits should be:Response:

Answer: B


NEW QUESTION # 253
The purpose of compendial methods in the testing of pharmaceuticals is to:
Response:

Answer: A


NEW QUESTION # 254
Version control and configuration management in computerized systems are important because they:
Response:

Answer: B


NEW QUESTION # 255
......

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