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ASQ CPGP Exam Syllabus Topics:

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

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ASQ Certified Pharmaceutical GMP Professional Sample Questions (Q394-Q399):

NEW QUESTION # 394
What type of specifications must be determined for intermediates used in production?
Response:

Answer: B


NEW QUESTION # 395
Which of the following are included in the validation and qualification process for new equipment in a pharmaceutical facility?
(Choose two)
Response:

Answer: A,C


NEW QUESTION # 396
GMPs are designed primarily to:

Answer: A


NEW QUESTION # 397
Which of the following is NOT typically an in-process test?
Response:

Answer: B


NEW QUESTION # 398
Which of the following is considered a critical process parameter (CPP) for sterilization?
Response:

Answer: B


NEW QUESTION # 399
......

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