How to respond to 483 validation finding we disagree with?

Ronen E

Problem Solver
Moderator
"Validation" is generally applied to so-called special processes, where specifications can't be verified/measured after production.
This is also the case for the FDA. "Generally".
Perhaps the FDA's "twist" is that they don't really care that "the specifications can be verified/measured after production", if they aren't in fact.
 

Tidge

Trusted Information Resource
@Tidge answered the question for me. "Validation" is generally applied to so-called special processes, where specifications can't be verified/measured after production.
This is also the case for the FDA. "Generally".
Perhaps the FDA's "twist" is that they don't really care that "the specifications can be verified/measured after production", if they aren't in fact.

This concept ("if you aren't verifying, the process requires validation") was a mental door that I needed to recognize, open, and walk through early in my career in medical device manufacturing. Writing only for myself: It was tempting to assuage the small measure of bitterness I (may have) felt with rationalizations, but rationalizations are not objective evidence that the individual devices being manufactured are meeting the necessary specifications to guarantee safety and effectiveness. On a personal note: This is one of the areas (of medical device design and manufacture) where I think the US regulators have a more appropriate and straightforward explanation/expectation that European regulators, YMMV.

I have witnessed enough potential issues with non-validated processes (see also issues that arise from an over-reliance on "100% inspections") that I recognize the wisdom of this approach, not just for compliance but also for quality (in the broadest possible use of the word).
 

Ronen E

Problem Solver
Moderator
I have witnessed enough potential issues with non-validated processes (see also issues that arise from an over-reliance on "100% inspections") that I recognize the wisdom of this approach, not just for compliance but also for quality (in the broadest possible use of the word).
"100% inspection" is never really 100% (or if we want to be pedantic, never really 100% effective), as is very colourfully demonstrated at the beginning of almost every Quality 101 course...

Process validation is the conceptual child of the true QA mindset, while "100% verification" in not much more than "good old" QC. So yes, it's a great approach for assuring quality in the broader sense.
 
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