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
Awareness(Detectability)
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.
- Risk
- 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 :
- Configuration of system to be cleaned.
- Cleaning process to be employed
- Cleaning agents to be used
- Method capability [Detection of residue in terms of previous product & cleaning agent traces]
- Cleaning Methodology [Manual or Machine based]
- Operator variability
- Next products to be taken in system
and the top most a risk assessment protocol with evaluation from CFIAT.
Happy Reading !
Mr.Ashish,
Thanks for your inputs.
thanks alot for your help
It is really very useful