Risk analysis

Dear All,

In which stage of qualification activity of equipment quality risk analysis shall be address.

Prashant Mhetre

Integrating QRM in the Product Lifecycle is the best approach.
ICH Q 8,9 & 10 guidelines are interlinked.
Its is a link between Pharmaceutical Quality system and Quality Risk Management.

On the Product Quality side QRM is applicable in all activities starting from Vendor selection to site desining to Operation.

Vendor Selection
Change control
Discrepancy Management
Annual product review

QRM deals with patient risk compliance.This activity starts ahead of purchasing equipment. It starts with a validation group in which specific people with knowledge about risk will review all documents.