Process Validation Quiz

Why do we perform validation?

• Regulatory Requirement

• Patient Safety

• Business Reasons

• All of the above

What is the purpose of VMP?

• To outline a company's approach to validation

• To detail different departments roles and responsibilities in validation studies

• To outline the projects planned for the year ahead

• All of the above

What is the first step of the V-Model?

• Functional Specification

• User requirement specification

• User request

• User wishlist

What is the testing performed at the supplier site called?

• Factory Testing

• Site acceptance test

• Factory acceptance test

• Commissioning

Identify whether these tests would be found in an installation qualification protocol or an operational qualification protocol (IQ/OQ)

1. Identification of principle components

2. Performance of functional testing

3. Verification of access/security

What is the first stage of the process validation lifecycle called?

• Continued Process Verification

• Process Design

• Process Qualification

What type of attributes are Critical Quality Attributes?

• Chemical

• Physical

• Microbial

• All of the above

Which of these approaches to Validation are no longer allowed by the regulatory authorities?

• Prospective

• Concurrent

• Retrospective

What happens if a test result fails during process validation?

• The batch is rejected

• The process validation study fails

• An investigation is performed to determine the root cause