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ASQ CPGP Exam Syllabus Topics:

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

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ASQ Certified Pharmaceutical GMP Professional Sample Questions (Q133-Q138):

NEW QUESTION # 133
Risk evaluation and mitigation strategy (REMS) is implemented to:
Response:

Answer: C


NEW QUESTION # 134
Which of the following statements is true about marketing requirements and compendia?
Response:

Answer: D


NEW QUESTION # 135
When assessing the impact of proposed changes, what should be considered?
Response:

Answer: D


NEW QUESTION # 136
In assessing proposed changes, the focus should be on:
Response:

Answer: D


NEW QUESTION # 137
Environmental monitoring is least likely to be a focus during which phase of product development?
Response:

Answer: B


NEW QUESTION # 138
......

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