820.75 Process Validation including Suppliers

I

Ironcountry

#1
I would like to know about medical device OEM's and suppliers recent experiences when audited by the FDA, specifically validations. For example, what FDA's stance is when a process is not validated? Does the presence of a comprehensive plan make a difference??
 
Elsmar Forum Sponsor
#2
I share your interest in hearing stories of recent encounters with the FDA. I can tell you that a major OEM was here this week to help qualify (audit) us to build a more complex device, in a higher FDA Class, then the components we've been supplying them for years...

I give them credit... they were thorough, and seemed to agree amongst themselves of what it takes to get these process validations and equipment qualifications up to where they should be...

I gave Elsmar Cove credit during a post-audit debrief meeting we had yesterday; none of their observations were new to me, and really what I heard from them was consistent with the consensus opinions which develop over some of the threads here...

A "comprehensive plan" is very important; it should be through and specifically include processses which are planned for verification as opposed to validation, as well as present a program of formal monitoring and re-validation...

Statistical rationale is a hot topic as well, for sample sizing, as well as confidence levels of any conclusions drawn through capability studies... you've got to be covered as to justifying your inputs as well as justifying conclusions drawn from your outputs...

Following admonitions to include considerations of risk in designing these verifications & validations, a relatively simple approach of using the highest severity seemed to be received well... also, I really tried to follow the process validation guidance document (GHTF) closely point-to-point to ensure protocols were planned well enough... this was seemingly sufficient...

The question I came away with is: having never met FDA, are they typically expected to be exacting above and beyond the requirements of a big Customer? I feel like we got a pretty good workout this week, and hopefully we'll be in good shape in case FDA ever does drop in!
 
I

Ironcountry

#3
My company recently sent engineers for validation training conducted by AAMI, from what they said about half of the audience were FDA inspectors. To answer your question regarding whether they would go above and beyond a big customer, I would say expect them to. Not all "big customers" are the same, I have heard some OEMs are extremely thorough while others are less so. I would expect in these times, the FDA would be very thorough.
 

Statistical Steven

Statistician
Staff member
Super Moderator
#5
Can anyone else provide input?
Not sure I understand the question fully but let me share some experiences with you. The GHTF document section 3.1 has the flow diagram for the decision to validate or verify a process. Section 3.2 gives examples of processes expected to be validated and those that are special processes that do not require validation but should have verification and a control plan.

If you have a process that should be validated but is not currently validated, having a gap analysis with a plan is sufficient provided the plan is reasonable to the FDA auditors satisfaction.

Now to your initial question, if you have not addressed validation in your QMS you will usually see a minimum of a 483 and most likely a warning letter. Validation is critical and a simple search of the FDA Warning Letter database can show you the extent to which the agency requires validation.

Does that help?
 
M

MIREGMGR

#6
are they typically expected to be exacting above and beyond the requirements of a big Customer?
I'm not quite sure where the question goes. FDA's expectations are pretty well documented in 21CFR 820 and the other rules and in their guidances. As noted, the Warning Letter history is very informative. The QSIT guide provides an exact list of the inspector's questions for a basic surveillance audit.

In my experience, their audits aren't qualitative, with the inspector just deciding that your system is "good enough". Rather, they want a range of technical and managerial systems in place and objectively operating, and either you have them or you don't.
 

Ronen E

Problem Solver
Staff member
Moderator
#7
I second the last 2 posts above.

Published warning letters from recent months show that process validation is a hot topic -- almost all companies cited for part 820 violations are found to have inadequate process validation(s), to some extent.

If you conduct a systematic review of such warning letters during, say, the last 12 months, I'm sure you can gain some useful insights re. FDA inspectors expectations in that regard.

Cheers,
Ronen.
 
M

MIREGMGR

#8
what FDA's stance is when a process is not validated? Does the presence of a comprehensive plan make a difference??
Getting specific:

What's the timeline for your plan? When did you discover you had a problem?

Why don't you have the problem resolved already? Validation doesn't take long if you give it a high enough resource ($$, engineer time) priority.

What does your plan do about every unit of product you produced/marketed prior to the process being validated, that is still within its declared lifetime?

Having an unacceptable (or no) answer to that last question has been the basis for a number of Warning Letters in the past several years.
 

Ronen E

Problem Solver
Staff member
Moderator
#9
Validation doesn't take long if you give it a high enough resource ($$, engineer time) priority.
Sometimes it does, especially when the output of the process requires lengthy testing, e.g. post ageing tests (even accelerated ageing can be lengthy at times).
 

patilrahuld

Starting to get Involved
#10
Can someone name a few external process validation training resources? Our firm wants to send few engineers on a process validation public training.
 
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