• Exam Code: CPGP
  • Exam Name: Certified Pharmaceutical GMP Professional
  • Certification Provider: ASQ
  • Corresponding Certification:ASQ Auditing
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ASQ CPGP Exam Syllabus Topics:

SectionWeightObjectives
Quality Systems18%- Quality management system design and implementation
- Documentation, change control, and records management
- Audits, corrective and preventive actions
Regulatory Agency Governance12%- Global regulatory framework and requirements
- Inspection, enforcement, and compliance processes
Infrastructure and Facilities12%- Facility design, maintenance, and utilities management
- Equipment qualification, calibration, and cleaning validation
Laboratory Systems14%- Testing methods, data integrity, and result reporting
- Laboratory controls, calibration, and validation
Product Development and Technology Transfer9%- Product lifecycle management and regulatory submissions
- Technology transfer, scale-up, and validation
Materials and Supply Chain Management12%- Inventory control, traceability, and distribution practices
- Supplier qualification, material receipt, and storage
Filling, Packaging, and Labeling13%- Filling operations, controls, and verification
- Packaging and labeling design and compliance
Manufacturing Systems16%- Contamination control, cleaning, and hygiene
- Sterile and non-sterile production requirements
- Process design, validation, and control

ASQ Certified Pharmaceutical GMP Professional Sample Questions:

1. Why is it important to differentiate requirements for the sampling environment based on the type of material?
Response:

A) Different materials require different ambient conditions to prevent alteration or contamination
B) It allows staff to choose their preferred working environment
C) To accommodate the personal preferences of the material suppliers
D) It is solely for regulatory compliance, without practical benefits


2. The primary purpose of supplier audits is to:

A) Reduce cost
B) Monitor supplier compliance and quality
C) Evaluate marketing capability
D) Check financial status


3. Which is the most appropriate disposal method for rejected raw materials?

A) Use for training
B) Give to another manufacturer
C) Return to vendor or destroy
D) Store indefinitely


4. Specification limits are assessed in relation to:
Response:

A) The color of the final product
B) The CEO's preferences
C) The number of employees in the facility
D) Registration or compendial requirements


5. The purpose of a Site Reference File (SRF) includes:
Response:

A) Describing the specifics of a site to inform regulatory inspections
B) Listing the cafeteria menu options
C) Advertising the site for potential investors
D) Presenting the site's annual holiday schedule


Solutions:

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

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