Risk Assessment

How can i make risk assessment for cleaning validation i.e. what are the items that i should include in the study?

RISK = f (Hazard, Exposure,Awareness)

Hazard (Severity)
a) Calculate the ADI
b)Calculate “Safety Treshold”

Exposure (Occurence)
a)Develop Robust cleaning process
b)Lower the residue data

a)Install Sensors-PAT
b) Monitoring (At-line/On-line)

Providing and reading proper regulatory guidelines for PAT,Product areas to be cleaned, Training programmes,Statistical based approaches so that adequancy of cleaning process can be demonstrated.

Hi Reem & Durga !

It was good to see a discussion regarding Risk Assessment on Cleaning Validation.

There are to things involved while we are talking about risk.

  1. Risk
  2. Impact

Both needs assessment, in case of cleaning the risk evaluation is directly linked with impact on next product.

The cleaning process risk assessment should include :

  1. Configuration of system to be cleaned.
  2. Cleaning process to be employed
  3. Cleaning agents to be used
  4. Method capability [Detection of residue in terms of previous product & cleaning agent traces]
  5. Cleaning Methodology [Manual or Machine based]
  6. Operator variability
  7. Next products to be taken in system

and the top most a risk assessment protocol with evaluation from CFIAT.

Happy Reading !

Thanks for your inputs.

thanks alot for your help
It is really very useful