MDM: PO DS

Question 1

What is a VMP and what should it contain?

Answer 1

A Validated master plan is a document which outlines the principles involed in the qualification of a facility, defining areas and systems to be validated and provides a written program for achieving and maintaining qualified facility

Question 2

1. What are the four main stages of validation and what is done at each stage?

Answer 2

• Stage 1 – Process Design
• Stage 2 – Process Validation or Process Qualification
• Stage 3 – Continued Process Validation

Question 3

1. What are the three types of process validation which can be carried out and how do they differ?

Answer 3

1. Traditional
2. continuous - used when product has been designed by a quality by desgin approach
3. hybrid - hybrid between continous and traditional. Used when substantinoal product and knowledge on process

Question 4

1. Why does cleaning validation need to be carried out?

Answer 4

Cleaning validation should be performed in order to confirm the effectiveness of any cleaning procedure for all product contact equipment.

Question 5

1. Why do we need a change control system?

Answer 5

• To evaluate the consequences of change before implicating it
• prevents costly revalidation methods and mistakes

Question 6

1. Why is revalidation required?

Answer 6

To ensure a system is still maintaine in a vaildated state