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ASQ CPGP Exam Syllabus Topics:

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

ASQ Certified Pharmaceutical GMP Professional Sample Questions:

1. Secure storage of reprocessed and reworked materials is important to prevent:
Response:

A) Cross-contamination
B) Employee satisfaction
C) Efficient use of space
D) Timely production schedules


2. A Certificate of Analysis (COA) for a raw material must be:
Response:

A) Complete, internally reviewed, and appropriately retained
B) Printed on recycled paper only
C) Accompanied by a gift or sample product
D) Signed by the CEO of the supplying company


3. Stability-indicating tests differ from release tests in that they:
Response:

A) Are designed to predict the product's stability over time
B) Focus on the product's immediate quality upon release
C) Are used to determine the product's color and texture
D) Assess the product's packaging integrity


4. For marketing authorization, the relationship between the USP, EP, and JP is best described as:
Response:

A) Identical across all regions.
B) Region-specific requirements.
C) Mutually exclusive.
D) Interchangeable.


5. What is the purpose of a Validation Master Plan (VMP)?
Response:

A) To provide a biography of the company's CEO
B) To outline the company's sales targets
C) To list the company's shareholders
D) To document the validation processes and procedures


Solutions:

Question # 1
Answer: A
Question # 2
Answer: A
Question # 3
Answer: A
Question # 4
Answer: B
Question # 5
Answer: D

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