ASQ Certified Pharmaceutical GMP Professional : CPGP

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ASQ CPGP Exam Syllabus Topics:

ASQ Certified Pharmaceutical GMP Professional Sample Questions:

Question #1

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

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

Question #2

Which of the following is a criterion for further investigation of atypical laboratory results?
Response:

A. Results are within trend but just outside of specification limits
B. Atypical results are confirmed and significantly impact product quality
C. Only results that are favorable to the desired outcome
D. All atypical results, regardless of impact

Question #3

The design of water supply systems in pharmaceutical manufacturing should consider:
Response:

A. Unit operations like dechlorination and reverse osmosis
B. The color of the water
C. The proximity to natural water bodies
D. Taste preferences of the staff

Question #4

How do retest dates differ from expiration dates on pharmaceutical materials?
Response:

A. Expiration dates are suggestions, while retest dates are mandatory.
B. Retest dates and expiration dates are interchangeable terms.
C. Retest dates are only used for decorative purposes.
D. Retest dates indicate when a material should be re-evaluated for quality; expiration dates indicate when a material is no longer safe to use.

Question #5

In the context of laboratory handling controls, what is the significance of labeling and tracking the quantities of reagents and standards?
Response:

A. It is only relevant for audits and has no impact on day-to-day operations
B. It ensures that laboratory staff are aware of the available resources
C. It is crucial for maintaining the traceability and integrity of laboratory work
D. It is a practice that can be disregarded if the laboratory is small

Solutions: