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]
>
> ##############################################################
> TechNet Mail List provided as a free service by IPC using LISTSERV 1.8c
> ##############################################################
> To subscribe/unsubscribe, send a message to [log in to unmask] with following text in
> the body:
> To subscribe:   SUBSCRIBE TECHNET <your full name>
> To unsubscribe:   SIGNOFF TECHNET
> ##############################################################
> Please visit IPC web site (http://www.ipc.org/html/forum.htm) for additional
> information.
> If you need assistance - contact Gayatri Sardeshpande at [log in to unmask] or
> 847-509-9700 ext.5365
> ##############################################################

##############################################################
TechNet Mail List provided as a free service by IPC using LISTSERV 1.8c
##############################################################
To subscribe/unsubscribe, send a message to [log in to unmask] with following text in
the body:
To subscribe:   SUBSCRIBE TECHNET <your full name>
To unsubscribe:   SIGNOFF TECHNET
##############################################################
Please visit IPC web site (http://www.ipc.org/html/forum.htm) for additional
information.
If you need assistance - contact Gayatri Sardeshpande at [log in to unmask] or
847-509-9700 ext.5365
##############################################################