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ASQ CPGP Exam Syllabus Topics:

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

ASQ Certified Pharmaceutical GMP Professional Sample Questions:

Question 1

A key element of QMS structure includes:
Response:

A. Social media presence
B. Celebrity endorsements
C. Political affiliations
D. Organizational culture


Question 2

In laboratory investigations, the identification of unknowns typically involves:
Response:

A. Consulting a psychic
B. Comparing test results to known standards or reference materials
C. Guessing based on previous experience
D. Using a single test method for identification


Question 3

What is the primary purpose of sample identification and handling procedures?
Response:

A. To speed up the testing process
B. To ensure samples are mixed properly
C. To maintain the integrity and traceability of samples
D. To reduce the cost of analysis


Question 4

Calibration and engineering change control procedures are implemented to:
(Choose two)
Response:

A. Ensure equipment settings are optimized for the fastest production time
B. Facilitate the live streaming of equipment operations
C. Guarantee that modifications do not affect the precision and accuracy of measurements
D. Maintain the integrity of manufacturing processes


Question 5

Packaging controls differ based on the:
Response:

A. Employee preferences
B. Marketing campaign
C. Type of packaging process
D. Time of year


Solutions:

Question 1
Answer: D
Question 2
Answer: B
Question 3
Answer: C
Question 4
Answer: C,D
Question 5
Answer: C

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