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ASQ CPGP Exam Syllabus Topics:

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

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ASQ Certified Pharmaceutical GMP Professional Sample Questions (Q348-Q353):

NEW QUESTION # 348
Health Canada is the federal department responsible for helping Canadians maintain and improve their health. In which country does it operate?
Response:

Answer: B


NEW QUESTION # 349
What is the primary purpose of the U.S. Annual Product Review (APR)? Response:

Answer: A


NEW QUESTION # 350
Which ISO standard is commonly referenced in the context of pharmaceutical quality management?
Response:

Answer: B


NEW QUESTION # 351
Equipment cleaning validation is necessary to:
Response:

Answer: A


NEW QUESTION # 352
Which of the following best describes the purpose of a system-based inspection?
Response:

Answer: C


NEW QUESTION # 353
......

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