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WorksheetsGAMP 5
Total questions: 10
Worksheet time: 5mins
Name
Class
Date
1.
In determining “fit for use,” attention should be focused on “those aspects that are critical to patient safety, product quality, and data integrity.”
a)
True
b)
False
2.
The key concepts to GAMP 5,
a)
Lifecycle approach within QMS.
b)
Scalable Lifecycle Activities.
c)
Leveraging Supplier Involvement.
d)
All of the above
3.
One of the interior principles of GAMP is that quality cannot be tested into a batch of product but must be built into each stage of the manufacturing process.
a)
False
b)
True
4.
GAMP® 5 recognizes five levels of hardware
a)
True
b)
False
5.
GAMP® 5 is a prescriptive method
a)
False
b)
True
6.
The key objectives of GAMP® 5 are Patient safety, Product quality and ____________
a)
CQA
b)
QbD
c)
Data Integrity
d)
All of the above
7.
The end-result should be not just be an auditable set of documents, but hopefully a computer system that does what it is meant to do!
a)
False
b)
True
8.
The validation of a computerised system to achieve and maintain GxP compliance and not necessarily throughout the lifecycle of that system
a)
True
b)
False
9.
Understanding the difference between configuration and customization is the key to managing software and validation risk.
a)
True
b)
False
10.
Virtual software solutions such as VMware are not necessarily to be validated since they control the operation of platform components
a)
True
b)
False
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