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ASQ CPGP Exam Syllabus Topics:

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

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ASQ Certified Pharmaceutical GMP Professional Sample Questions (Q399-Q404):

NEW QUESTION # 399
What is a crucial aspect of documenting a change implementation plan?
Response:

Answer: D


NEW QUESTION # 400
CAPA effectiveness is confirmed by:

Answer: C


NEW QUESTION # 401
In terms of production operations, which of the following requires specific gowning, sanitization, and hygiene practices?
Response:

Answer: A


NEW QUESTION # 402
Which of the following is an example of a critical quality attribute?
Response:

Answer: D


NEW QUESTION # 403
Mutual recognition agreements in the pharmaceutical industry typically facilitate:
Response:

Answer: B


NEW QUESTION # 404
......

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