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ASQ CPGP Exam Syllabus Topics:

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

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ASQ Certified Pharmaceutical GMP Professional Sample Questions (Q329-Q334):

NEW QUESTION # 329
Environmental conditions such as temperature and humidity are controlled during the storage of materials to:
Response:

Answer: D


NEW QUESTION # 330
To accurately interpret data on processes or products that are out-of-specification or out-of-trend, it is crucial to analyze the _______ of atypical results.
Response:

Answer: C


NEW QUESTION # 331
When initiating an investigation for atypical results in a chemical test, which of the following is the first step?
Response:

Answer: D


NEW QUESTION # 332
During a for-cause inspection, regulators focus on:
Response:

Answer: C


NEW QUESTION # 333
The primary goal of applying phase-appropriate GMPs is to:
Response:

Answer: B


NEW QUESTION # 334
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