Hi,
Please explain me about how the Impact Assessment (Direct impact, critical component) done to know the criticality?
Could any one provide me a literature regarding impact assessment.
Regards,
Anil
I have a different question regarding this topic.
What are the differences between a system and component?
What criteria must one use to identify how many components a system has?
If a system has only one component which assessment must be used, a system impact assessment or a component impact assessment or both?
To answer anilkumar’s question: Refer to ISPE Baseline Guide: Commissioning and Qualification.
In addition you must comply with the latest guideline by the ICH Q9 on ‘quality risk management’.
Plus the ISPE has reading material titled ‘Risk Management for the Manufacture of Pharmaceutical Products (RAMPP)’.