ASQ Auditing CPGP

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ASQ Certified Pharmaceutical GMP Professional Sample Questions:

1. Technology transfer is crucial when there is a __________ change.
Response:

A) marketing strategy
B) manufacturing site
C) packaging color
D) sales team

2. An open computerized system is characterized by:
Response:

A) Its connectivity and potential interaction with external systems
B) Its ability to operate independently of any network connections
C) Its lack of need for any security measures due to its architecture
D) Its direct control by a single user without external interactions

3. The primary goal of applying phase-appropriate GMPs is to:
Response:

A) Increase the complexity of documentation
B) Focus solely on the aesthetics of the final product
C) Ensure the product meets predefined quality criteria throughout its lifecycle
D) Reduce the need for regulatory oversight

4. Which of the following should be assessed during an impact assessment?
(Choose two)
Response:

A) Potential effects on patient safety
B) The effect on product quality
C) Changes to the company stock price
D) The impact on future marketing campaigns

5. During scale-up, __________ principles guide the increase in production volume while maintaining product quality.
Response:

A) outsourcing and contracting
B) financial and marketing
C) development and validation
D) design and aesthetics

Solutions: