Quality Risk Assessment for Drug Products

Dear Forum,

How to carryout risk assessment for drug products (Oral solid dosage form) during development stage? Can anyone guide me.
Please share the document template for the above…

C. Suresh

Identify critical control points (CCP’s) in product processing.
The CCP’s based on Quality checks, prevention of cross contamination, cleaning of Equipments, Dispensing procedures, Exposure to environment (HVAC considerations like Closed and Open processing) , Exposure effects to manufacturing and operating personnel.
Draft a plan give it a risk numbering at all CCP’s
This is ideal way to start a risk document. Risk is too volatile subject as of now in Pharma industry. Many experts must dedicate their time and effort from concept to implementation and drafting an assessment report.


Thanks Mr. Prasad.

Let me work on it.