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ASQ CPGP Exam Syllabus Topics:

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

ASQ Certified Pharmaceutical GMP Professional Sample Questions:

Equipment used in packaging operations must be __________ and maintained.
Response:

  • A. qualified
  • B. manually operated
  • C. decorated
  • D. outsourced
Reveal Solution  Discussion  0

Correct Answer: A  🗳️

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

  • A. To evaluate the compliance and quality performance of a product annually
  • B. To analyze the marketing strategies for a product
  • C. To determine the product's popularity among consumers
  • D. To assess the financial performance of a product
Reveal Solution  Discussion  0

Correct Answer: A  🗳️

The purpose of critical manufacturing step verification is to ensure:
Response:

  • A. The accuracy and reliability of the manufacturing process
  • B. The social media strategy is effective
  • C. Compliance with fashion trends
  • D. Employee satisfaction levels
Reveal Solution  Discussion  0

Correct Answer: A  🗳️

Quality control testing for pharmaceuticals requires the use of compendial methods to ensure:
Response:

  • A. The fastest turnaround time for results.
  • B. Compliance with international standards and regulations.
  • C. Minimal use of laboratory resources.
  • D. Preference for older, established testing methods.
Reveal Solution  Discussion  0

Correct Answer: B  🗳️

Formal contracts or quality agreements with suppliers should include provisions for:
(Choose two)
Response:

  • A. Flexible payment terms based on the buyer's financial condition
  • B. Audit and inspection rights
  • C. Continuous improvement and corrective action procedures
  • D. Regular social events to maintain a good working relationship
Reveal Solution  Discussion  0

Correct Answer: B,C  🗳️

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