Yes indeed , scorching but very true summary of the recent "evolution" (sort
of), David.
Apart from THE DRAFT ; we use FDA's Subpart G: Production and Process
Controls 1996,
and as you said 87's issue of Guideline on General Principles of Process
Validation .
On old GMP blue book ; nothing spectacular, agree;
but what i like on FDA (hope they read this) is the empirical approach so
differing to standard standards,
that is not telling you what to do ; but driving home message of REALLY
thinking about it,
from roots up .
In the end the finished (internal)procedures are that much better than
standard (often obsolete) follow up's;
that with all due respect to din/bs/ansi/iso's i found this method much more
encouraging innovation and breaking ice where some (as MIL's locks) would
not allow us to go .
Glad you see merits in GHTF , personally i think this is the way for 3rdK,
as in my opinion classic standards won't be able to cope with speed &
volume,
of popcoming nethots and technologies .
(yes, n it is)
To really fog gaze ; wouldn't give them past this century
(it/mil/med/aeronautical/space/etc.)
Paul Klasek
http://www.resmed.com
-----Original Message-----
From: David Fish [mailto:[log in to unmask]]
Sent: Thursday, 17 February 2000 10:00
To: [log in to unmask]
Subject: Re: [TN] Process Validation Check Sheet
Carl: Back in 1987, the FDA issued a guideline for process validation, but
it wasn't
really clear about "installation qualification," "operational
qualification," and
"performance qualification." The three steps required to do a process
validation.
But, they didn't let that bother them.
Meanwhile, the folks over at IOS xeroxed BSI BS5750, which was a xerox of
MIL-STD-2000,
and called it ISO9000. Immediately, well not immediately, some time later,
the FDA
realized that the GMP documents were pathetic. So, they xeroxed ISO9000.
Then, all
the consultants that specialized in interpreting the FDA's GMP realized that
they would
have to compete with all huddling masses of established ISO9000 consultants,
and they
were not happy. So, they complained that ISO9000 left-out some really
important
stuff. So the FDA made a couple of passes at writing a Q9000-like document
for the
medical device biz.
Then a really smart consultant talked the FDA into forming a Global
Harmonization Task
Force (GHTF) to harmonize the way medical devices are regulated worldwide.
The GHTF was
founded by the U.S., Canada, Japan, Australia, and the European Union.
One of their products is the "Draft Global Harmonization Task Force Study
Group 3
Process Validation Guidance." It has all those whining ex-GMP consultants
merrily
scurrying around scaring the beejangers (money) out of medical device
suppliers.
The language in the final version of the GHTF Process Validation Guidance is
expected
to show no major changes from the draft (which was unofficially endorsed by
the FDA).
However, some of the terminology will "shift," whatever that means. It is
available at
http://www.fda.gov/cdrh/comp/ghtfproc.html and
http://www.fda.gov/cdrh/comp/ghtfproc.pdf.
Bottom line: you need labels like
http://www.ualco.com/EXPORTQA/EXPORTQA/DIR_HTML/13.HTM
Good luck
Dave
Carl Barnes wrote:
> Technetter's need help,
>
> I have been tasked with implementing a New Customer Introduction Team.
Along
> with the task I have been asked to create/design a "Process validation
Check
> Sheet" for all processes involved. Does anyone have suggestions or
examples
> of checksheets? Any amount of detail would be appreciated. Please send
> either to TechNet or directly to me at the address below. Thanks in
advance
> for any and all replies.
>
> Thank You
> Carl Barnes
> Quality Analyst
> http:[log in to unmask]
>
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