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ASQ CPGP Exam Syllabus Topics:

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

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ASQ Certified Pharmaceutical GMP Professional Sample Questions (Q249-Q254):

NEW QUESTION # 249
Security requirements for computerized systems include all EXCEPT:
Response:

Answer: A


NEW QUESTION # 250
The role of a Qualified Person includes ensuring:
Response:

Answer: C


NEW QUESTION # 251
A design space is established to:
Response:

Answer: B


NEW QUESTION # 252
The role of the supervisor in ensuring training effectiveness includes:
Response:

Answer: C


NEW QUESTION # 253
Which of the following is a key element evaluated in the European Product Quality Review (PQR)?
Response:

Answer: D


NEW QUESTION # 254
......

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