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ASQ CPGP Exam Syllabus Topics:

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

ASQ Certified Pharmaceutical GMP Professional Sample Questions:

1. Which ISO standard is commonly referenced in the context of pharmaceutical quality management?
Response:

A) ISO 14001
B) ISO 9001


2. Batch records must be reviewed for certain required elements. Which of the following is NOT one of these elements?
Response:

A) Employee vacation schedules
B) Critical manufacturing step verification
C) Sections on yields
D) Proper issuance


3. Process capability indices (Cp and Cpk) are used to:
Response:

A) Predict future financial performance
B) Measure the process's ability to produce within specified limits
C) Assess employee productivity
D) Calculate raw material costs


4. Packaging line setup instructions are crucial for ensuring:
Response:

A) Decorative consistency
B) Marketing alignment
C) Financial efficiency
D) Correct assembly of components


5. When labeling reagents, solutions, and standards, which of the following information must be included?
Response:

A) Color and viscosity
B) Physical appearance and smell
C) Price and supplier name
D) Opened-on date, expiry date, and quantity


Solutions:

Question # 1
Answer: B
Question # 2
Answer: A
Question # 3
Answer: B
Question # 4
Answer: D
Question # 5
Answer: D

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