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  • Total Questions: 520
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  • Total Questions: 520
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  • Total Questions: 520
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ASQ CPGP Exam Syllabus Topics:

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

ASQ Certified Pharmaceutical GMP Professional Sample Questions:

Question 1

Which stock rotation methods are used to minimize the risk of using expired or outdated materials?
(Choose two)
Response:

A. First-expired/first-out (FEFO)
B. Most-expensive/first-out (MEFO)
C. First-in/first-out (FIFO)
D. Last-in/first-out (LIFO)


Question 2

Which compendium is a requirement for marketing authorization in the United States?
Response:

A. European Pharmacopoeia (EP)
B. United States Pharmacopoeia (USP)
C. Japanese Pharmacopoeia (JP)
D. All of the above


Question 3

Successful technology transfer activities include all EXCEPT:
Response:

A. Product renaming
B. Capability studies
C. In-process control studies
D. Ranging studies


Question 4

The main reason for the traceability of intermediates in pharmaceutical manufacturing is to:
Response:

A. Allow for creative marketing
B. Ensure safety and efficacy through the supply chain
C. Make the packaging more attractive
D. Reduce the need for quality control


Question 5

In terms of compendia, required chapters are to informational chapters as:
Response:

A. Expensive is to cost-effective.
B. Complicated is to simple.
C. Mandatory is to optional.
D. Outdated is to modern.


Solutions:

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

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