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ASQ CPGP Exam Syllabus Topics:

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

ASQ Certified Pharmaceutical GMP Professional Sample Questions:

What is the primary objective of mutual recognition agreements in pharmaceutical regulations?
Response:

  • A. To recognize the regulatory inspections and approvals of other jurisdictions.
  • B. To create a single pharmaceutical market across countries.
  • C. To unify the prices of pharmaceutical products globally.
  • D. To standardize the branding of pharmaceutical products.
Reveal Solution  Discussion  0

Correct Answer: A  🗳️

Filling equipment must be controlled to:
Response:

  • A. Verify filling criteria are met
  • B. Decrease maintenance time
  • C. Enhance aesthetic appeal
  • D. Reduce energy consumption
Reveal Solution  Discussion  0

Correct Answer: A  🗳️

Controls to prevent contamination during filling include:
(Select two)
Response:

  • A. Regular equipment calibration
  • B. Use of HEPA filters
  • C. Reducing production speeds
  • D. Employee training programs
Reveal Solution  Discussion  0

Correct Answer: A,B  🗳️

The main difference between systems and process audits is that systems audits evaluate:
Response:

  • A. The process efficiency only
  • B. Individual employee performance
  • C. The end product quality
  • D. The entire quality system
Reveal Solution  Discussion  0

Correct Answer: D  🗳️

Packaging line setup instructions are crucial for ensuring:
Response:

  • A. Decorative consistency
  • B. Correct assembly of components
  • C. Marketing alignment
  • D. Financial efficiency
Reveal Solution  Discussion  0

Correct Answer: B  🗳️

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