"Special Process" Validation Requirements (21 CFR Part 820)

M

maaquilino

#11
I have a customer who states the following:

"The FDA expects special processes to be validated. It is in the QSR's".

I fully accept that processes such as sterilization, injection molding, etc., require validation.

But can anyone show where in the QSR's it states that "special processes" must be validated? Who defines what is special?
Ajit already answered this very well, but if a customer told me that, the first thing I'd be asking the customer to show me is where it states that in the QSR ;)
 
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Ronen E

Problem Solver
Staff member
Moderator
#13
Yes.

Sometimes I feel we rely too much on regulators to tell us how to run our businesses.

John
:confused:

Have you considered that the QSR is mostly best practices, honed over time?

I think that one good thing about the QMS regulations is that they are much less affected by short-term / short-range considerations than the average business would normally be, and in many cases they not only serve the public's best interest but also the manufacturer's interest for the long run. True, many small businesses don't have deep pockets, however investing in a proper QMS in the early stages is just like buying production machinery - it should be in the strategy from day 1 and accounted for in the business plan. I estimate ~90% of new medical device businesses fail to do so and hence hit a brick wall at some point.

The QSR actually has many degrees of freedom in it. What manufacturers might be doing "too much" is relying on incompetent consultants, long-standing unfounded "industry truths" and canned thinking.

Cheers,
Ronen.
 

John Broomfield

Staff member
Super Moderator
#14
:confused:

Have you considered that the QSR is mostly best practices, honed over time?

I think that one good thing about the QMS regulations is that they are much less affected by short-term / short-range considerations than the average business would normally be, and in many cases they not only serve the public's best interest but also the manufacturer's interest for the long run. True, many small businesses don't have deep pockets, however investing in a proper QMS in the early stages is just like buying production machinery - it should be in the strategy from day 1 and accounted for in the business plan. I estimate ~90% of new medical device businesses fail to do so and hence hit a brick wall at some point.

The QSR actually has many degrees of freedom in it. What manufacturers might be doing "too much" is relying on incompetent consultants, long-standing unfounded "industry truths" and canned thinking.

Cheers,
Ronen.
Ronen,

I do not mean to devalue regulations and regulators as valuable sources of knowledge. I do object to the organization waiting to be told what to do by a regulator instead of deciding for itself as a competent organization.

Imagine a filthy kitchen remaining unclean until the regulator shuts down the restaurant. I trust we agree the restaurant should not even be in business.

Imagine making something that conceals defects with an unvalidated process until being told by a regulator to stop. Should this organization be in business?

Likewise, imagine working for an organization that improves nothing until the auditor issues a nonconformity statement!

John
 

Sam Lazzara

Trusted Information Resource
#15
Interestingly, the 2004 GHTF guidance document shows "Special processes" in the Table of Contents but that TOC does not match the content of the document. So I guess FDA got in there to "fix" the body of the document but then someone forgot to update the TOC.

Reminds me of the opposite of this quote from the 1982 Poltergeist movie:
You SOB, you moved the cemetery but you left the bodies, didn't you?!
You SOB! You left the bodies and you only moved the headstones!!
YOU ONLY MOVED THE HEADSTONES!!! WHY?! WHY?!!!


On another note, the term "fully" still makes me pull my hair out.
But it was removed from clause 7.5.2 of ISO 9001:2008 and is not present in ISO 13485:2003. I also don't see it in ISO CD 13485:2014.

The organization shall validate any processes for production and
service provision where the resulting output cannot be or is not verified
by subsequent monitoring or measurement and, as a consequence,
deficiencies become apparent only after the product is in use or the
service has been delivered.
 
M

maaquilino

#16
:confused:

Have you considered that the QSR is mostly best practices, honed over time?

I think that one good thing about the QMS regulations is that they are much less affected by short-term / short-range considerations than the average business would normally be, and in many cases they not only serve the public's best interest but also the manufacturer's interest for the long run. True, many small businesses don't have deep pockets, however investing in a proper QMS in the early stages is just like buying production machinery - it should be in the strategy from day 1 and accounted for in the business plan. I estimate ~90% of new medical device businesses fail to do so and hence hit a brick wall at some point.

The QSR actually has many degrees of freedom in it. What manufacturers might be doing "too much" is relying on incompetent consultants, long-standing unfounded "industry truths" and canned thinking.

Cheers,
Ronen.
Exactly! When I first read the QSR and most things about QMS, it all seemed like just good business practices to me, and common sense. Unfortunately, common sense isn?t that common anymore, and some companies don?t want to put the time, effort, resources, and money into what it takes to do a QMS for their company. I believe that of more companies saw how a good, uncomplicated QMS can actually save them money and put out a better product ? on schedule and within budget no less, more would jump on board with it.
 
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