Exam 3

Question 1

________________ prevents cases of counterfeit products from reaching the market.

Emergency Recall
GDP
Segregation
Wholesale License
Serialization

Answer 1

Serialization

Question 2

Method Validation can only be created for analytical processes electronically and can include data software

True
False

Answer 2

False

Question 3

ICH guidances became mandatory for the US in 2013.

True
False

Answer 3

False

Question 4

Who is responsible for the ensuring that quality system is implemented?

Quality Risk Team
Quality Assurance
Distributors
Quality Unit
Management Representatives

Answer 4

Management Representatives

Question 5

______________ consists of management responsibilities, resources, manufacturing operations, and evaluation activities in order to be robust.

Six Sigma
Quality System
Quality System Concepts
Quality Guidances
Quality by Design

Answer 5

Quality System