What is the need of Risk Assessment?

GOOD MANUFACTURING PRACTICE (cGMP) RISK ASSESSMENT
1

What is the need of risk assessment in qualification activities. Why we are going to do such studies?

2

please expand perhaps using an example

3

Dear Uday…
U have a good question…
Coz Risk assessement is very important topic in pharma industry now a days.
Risk assessemnt must be consider for qualification of every system like,water,area,cleaning,equipment.
Now a days regulatory bodies r also very keen regarding risk managenment.

There is ICH guideline Q9 regarding Risk managenment.

Regarding evaluation of risk there must be provision in every qualification protocol that if system goes wrong during validation also during normal run,what precautions shall be taken to prevent the that particular system.

Regards

Prasad P.Aparajit