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ASQ CPGP Exam Syllabus Topics:

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

ASQ Certified Pharmaceutical GMP Professional Sample Questions:

1. The purpose of supplier, vendor, and contractor quality management systems is to:
(Choose two)
Response:

A) Minimize the environmental impact of manufacturing processes
B) Ensure compliance with applicable standards and regulations
C) Protect the quality and safety of the final product
D) Guarantee the highest profit margin possible


2. A major change in a validated process requires:

A) Engineering notification only
B) Approval but no documentation
C) No action if risk is low
D) Change control and potential re-validation


3. Development criteria for in-process inspections should include:
Response:

A) Marketing feedback loops
B) Seal tests
C) Color preference surveys
D) Packaging aesthetics


4. Destruction processes must ensure that materials are disposed of without harming the
___________.
Response:

A) Environment
B) Packaging design
C) Company's profit margins
D) Marketing strategies


5. Reserve samples must be retained to:
Response:

A) Comply with regulatory requirements for post-market testing
B) Enable future promotional activities
C) Enhance the laboratory's collection
D) Reduce manufacturing costs


Solutions:

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

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