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ASQ CPGP Exam Syllabus Topics:

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

ASQ Certified Pharmaceutical GMP Professional Sample Questions:

1. What are potential sources of mix-up in material storage, and how can they be minimized?
(Choose two)
Response:

A) Material segregation
B) Using a single storage area for all types of materials
C) Special storage for rejects
D) Uniform labeling for all materials


2. Returned goods must be evaluated to ensure they meet ___________ standards before being reissued.
Response:

A) Quality
B) Financial
C) Social
D) Aesthetic


3. Maintenance procedures for pharmaceutical equipment utilities are critical for:
(Choose two)
Response:

A) Winning industry design awards
B) Maintaining operational efficiency and safety
C) Enhancing the social media profile of the facility
D) Complying with regulatory and quality standards


4. The necessity of equipment cleaning validation varies depending on:
Response:

A) Whether the equipment is single-use, multi-use, or dedicated
B) The color and size of the equipment
C) The season in which the cleaning occurs
D) The personal preferences of the cleaning staff


5. The integrity of laboratory data can be compromised by:
Response:

A) Regular audit trail reviews
B) Errors, falsification, and fraud
C) Strict adherence to data acquisition protocols
D) Using the latest technology in data recording


Solutions:

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

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