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ASQ CPGP Exam Syllabus Topics:

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

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ASQ Certified Pharmaceutical GMP Professional Sample Questions (Q27-Q32):

NEW QUESTION # 27
The proper disposition of salvaged goods is crucial to prevent:
Response:

Answer: D


NEW QUESTION # 28
In the context of sampling processes, why is it necessary to ensure sampling utensils are appropriately cleaned or are single-use?
Response:

Answer: B


NEW QUESTION # 29
In the process of equipment validation and qualification, which are key factors to assess for ensuring quality and compliance?
(Choose two)
Response:

Answer: B,C


NEW QUESTION # 30
A key difference between development and validation studies is that validation studies:
Response:

Answer: D


NEW QUESTION # 31
Regular __________ is crucial to ensuring the effectiveness of contamination control measures.
Response:

Answer: D


NEW QUESTION # 32
......

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