ASQ
CPGP
Certified Pharmaceutical GMP Professional
Questions&AnswersPDF
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Question: 1
Health Canada is the federal department responsible for helping Canadians maintain and improve their
health. In which country does it operate?
Response:
A. United States
B. Australia
C. Canada
D. United Kingdom
Answer: C
Question: 2
During laboratory investigations, _______ methods are reviewed to ensure they are verified as suitable
for use in the testing lab.
Response:
A. compendial
B. outdated
C. unverified
D. improvised
Answer: A
Question: 3
A comprehensive supplier evaluation process should include which of the following methodologies?
(Choose two)
Response:
A. Pricing comparisons only
B. Supplier certification
C. Personal relationships with vendors
D. Supplied product or service performance trending
Answer: B,D
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Question: 4
Before a piece of equipment is used in production, which types of acceptance testing are typically
conducted?
(Choose two)
Response:
A. Factory Acceptance Testing (FAT)
B. Site Acceptance Testing (SAT)
C. Personal Acceptance Testing (PAT)
D. Online Acceptance Testing (OAT)
Answer: A,B
Question: 5
Environmental conditions such as temperature and humidity are controlled during the storage of
materials to:
Response:
A. Make the materials easier to transport
B. Prevent unauthorized access to the materials
C. Maintain the materials’ characteristics and ensure accurate testing results
D. Reduce the volume of materials stored
Answer: C
Question: 6
ICH Q10 integrates elements of _____ and continual improvement into the quality management system.
Response:
A. profit maximization
B. product lifecycle
C. competitive analysis
D. investor relations
Answer: B
Question: 7
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What are essential elements to review in Certificates of Analysis (COAs)?
(Choose two)
Response:
A. Marketing claims
B. Completeness and internal review
C. Appropriate retention and accessibility
D. Color of the product
Answer: B,C
Question: 8
Which of the following are considered global regulatory reporting requirements?
(Choose three)
Response:
A. Supplements
B. Field alerts
C. Product recalls
D. Marketing approvals
Answer: A,B,C
Question: 9
PIC/S guidelines emphasize the importance of data integrity. Which of the following is a key aspect of
these guidelines?
Response:
A. Data should be easily editable by anyone.
B. Data should be reproducible under similar conditions.
C. Records must be stored in a public cloud for accessibility.
D. Documentation practices must prevent data tampering.
Answer: D
Question: 10
The role of a supervisor in training effectiveness includes:
(Choose three)
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Response:
A. Ensuring staff are adequately trained
B. Monitoring market trends
C. Evaluating training outcomes
D. Overseeing financial audits
Answer: A,B,C
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