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ASQ CPGP Exam Syllabus Topics:

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

ASQ Certified Pharmaceutical GMP Professional Sample Questions:

How often are European Product Quality Reviews (PQRs) typically conducted?
Response:

  • A. Annually
  • B. Bi-annually
  • C. Every two years
  • D. Quarterly
Reveal Solution  Discussion  0

Correct Answer: A  🗳️

The Cp and Cpk indices measure:
Response:

  • A. Process and position capability related to specification limits
  • B. Employee performance
  • C. The effectiveness of marketing campaigns
  • D. Financial health of the manufacturing company
Reveal Solution  Discussion  0

Correct Answer: A  🗳️

Routine maintenance of air and water filters in a pharmaceutical facility helps to:
Response:

  • A. Prevent contamination and maintain a controlled environment
  • B. Impress regulatory inspectors with the facility's cleanliness
  • C. Ensure the filters are color-coordinated with the facility interiors
  • D. Decrease the workload on facility staff
Reveal Solution  Discussion  0

Correct Answer: A  🗳️

Closed computerized systems are defined by their:
Response:

  • A. Use exclusively in social networking contexts
  • B. Inability to process data efficiently
  • C. Ability to operate on an open internet platform without security
  • D. Lack of connectivity with other systems and controlled access
Reveal Solution  Discussion  0

Correct Answer: D  🗳️

What type of specifications must be determined for intermediates used in production?
Response:

  • A. Specifications based solely on cost
  • B. Specifications agreed upon by the marketing department
  • C. Color specifications only
  • D. Approved specifications for quality and safety
Reveal Solution  Discussion  0

Correct Answer: D  🗳️

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