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ASQ CPGP Exam Syllabus Topics:

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

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ASQ Certified Pharmaceutical GMP Professional Sample Questions (Q202-Q207):

NEW QUESTION # 202
The purpose of retaining reserve samples is to:Response:

Answer: A


NEW QUESTION # 203
Label reconciliation is performed to:
Response:

Answer: A


NEW QUESTION # 204
The validation of sterilization processes is essential for:
(Choose two)
Response:

Answer: B,C


NEW QUESTION # 205
Utilities design for production should prioritize:
Response:

Answer: B


NEW QUESTION # 206
Which of the following are critical components of a metrology program?
(Choose two)
Response:

Answer: A,C


NEW QUESTION # 207
......

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