Risk Assessment in Cleaning Validation

Hi All,

With increased focus of regulatory agencies on Implementation of ICH Q-8, Q-9 & Q-10, much focus on risk assessments.

Opinions invited for approaches to be kept during risk assement of cleaning validation.

Kindly do mention your replies with

  1. Key Factors to be considered.
  2. Benefits of Risk assessment in cleaning validation.


Key Factors to be considered :

  1. Worst case approach to be adopted, product matrixing.
  2. Grouping to similar groups


  1. Reduction in cleaning validation requirements at each individual pair.
  2. Extent identification will result in removal of additional work out which is not necessary / Required.

Happy Sharing !

Risk is different from Equipment to equipment.I can share my experience about risk for liquid based products.
For instance you are cleaning a tank with impeller:
-Area to be cleaned
-Area to be cleaned that is not covered by product inside the tank
-Impeller cleaning.
-Inside the impller wings
-On the shaft
-Bottom or base of impeller
-Contact time of detergent
-Recovery od detergent after the rinse or swab analysis od various points from Base drive impeller or propeller impleller.
-If you have propeller impleeler how the crevices in between the bolts analaysed.
-How much of detergent or product left over?
-What is the overall cross contamination ratio in the next product of different API or same API?
-Did these accumilated minor amounts degraded in solution by bacteria and formed toxic compounds?
-What is the cross reactivity with detergents?

Can you improve the design of tank or impeller so that the cleaning will be better?
How o you clean valves and joints?
How is recovery done from a valve that is placed at the bottom of the tank?
Are there any dead legs if the tank has a recirculatory system?

Many possible questions will be arrived based on experience and knowledge of Subject Matter experts(SME’s).

We always prefer to have Engg, QA,QC, Production guys to be a part of this particualr risk strategy.