Is Validation an ongoing process?

Mandy

Involved In Discussions
#1
Our company, which is a developing a Laboratory Developed Test (LDT), has a Master Validation procedure which states: Validation is an ongoing process.

I personally think that validation takes place to prove a process works and that's it, ie once it's done you sign the finished protocol and file in the DHF.

Why would it be ongoing?

Would appreciate some advice from other more experienced Covers.

Thanks
:thanx:
 
Elsmar Forum Sponsor
#2
What is of importance is to be sensitive to changes that happens in the validated environment, and be able to decide what extent of re-validation and at what time it is necessary to perform and record., so as to assure process stability is maintained .....

In this view some people may term it ongoing.
 

Bev D

Heretical Statistician
Leader
Super Moderator
#3
Somashekar is correct. re-validation is expected after any change. the level of validation is dependent on the failures that might occur due to the change.
 
I

in_cr_ove

#4
What is of importance is to be sensitive to changes that happens in the validated environment, and be able to decide what extent of re-validation and at what time it is necessary to perform and record., so as to assure process stability is maintained .....

In this view some people may term it ongoing.
I agree to your comments & would like to add:
Even a stable process is susceptible to temporal changes, that would need the process to be re-validated to ensure stability & capability. It may be a good idea to have re-validation at pre-decided regular intervals in addition to re-validation due to other known changes.
This may also qualify the statement "validation is an ongoing process".
 
#5
Why would it be ongoing?
Ongoing refers to the entire lifecycle of the process. Once the process is validated, it has to be "maintained in a validated status" and any changes to the validated status need to be evaluated for its impact to validated state.

Hence an "ongoing assurance is gained during routine production that the process remains in a state of control".
 
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