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ASQ CPGP Exam Syllabus Topics:

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

ASQ Certified Pharmaceutical GMP Professional Sample Questions:

1. Which of the following are critical components of a metrology program?
(Choose two)
Response:

A) Engineering change control
B) Calibration of instruments
C) Social media presence
D) Celebrity endorsements


2. In terms of compendia, required chapters are to informational chapters as:
Response:

A) Outdated is to modern.
B) Expensive is to cost-effective.
C) Mandatory is to optional.
D) Complicated is to simple.


3. Product seizure is a regulatory enforcement action used to:
Response:

A) Reward companies for outstanding compliance records.
B) Encourage voluntary compliance with marketing guidelines.
C) Address serious violations by removing products from the market.
D) Compel a company to relocate its manufacturing facilities.


4. Which of the following is a criterion for further investigation of atypical laboratory results?
Response:

A) Only results that are favorable to the desired outcome
B) Results are within trend but just outside of specification limits
C) All atypical results, regardless of impact
D) Atypical results are confirmed and significantly impact product quality


5. Change control for equipment in a pharmaceutical facility ensures that:
Response:

A) Staff can request equipment based on personal preference
B) The qualified state of equipment is maintained
C) All equipment is the latest technology, regardless of necessity
D) Equipment can be replaced with newer models for aesthetic reasons


Solutions:

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

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