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ASQ CPGP Exam Syllabus Topics:

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

ASQ Certified Pharmaceutical GMP Professional Sample Questions:

Question 1

Label reconciliation is performed to:
Response:

A. Confirm accuracy and investigate discrepancies
B. Track marketing trends
C. Simplify inventory management
D. Determine product popularity


Question 2

Evidence of line clearance must be __________.
Response:

A. verbally communicated
B. ignored
C. estimated
D. documented


Question 3

Which stages are crucial in ensuring that pharmaceutical manufacturing processes are validated?
(Choose two)
Response:

A. Financial Qualification (FQ)
B. Marketing Qualification (MQ)
C. Operational Qualification (OQ)
D. Performance Qualification (PQ)


Question 4

In designing water supply systems for pharmaceutical use, it's essential to prevent:
Response:

A. The use of colors that do not match the company logo
B. Back-flow or back-siphonage to maintain water quality
C. The visibility of pipes to visitors
D. The installation of water fountains in production areas


Question 5

Product audits evaluate the final _____ to ensure it meets all specifications and requirements.
Response:

A. product
B. idea
C. process
D. proposal


Solutions:

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

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