Ian,
The FDA allowed retro-validation for a period of time in the past but has
not been so lenient lately. You may have some difficulty passing an
inspection. I would recommend that you collect the data that you have
indicated below but then perform the equipment qualification properly
(i.e. - write the protocol, evaluate the system for a specific period of
time, verify installation, etc.). By collecting the data from the past, you
may be able to support the operations performed while the system was
operating in an non-validated state.
Troy Fugate
Pharmaceutical QA Consultant
513-860-3513
----- Original Message -----
From: "Ian Cook (by way of PDA Sci-Tech Forum <moderator@pda.org>)"
<ianc@honeyman.co.uk>
To: "PharmSciTech" <PharmTech@pharmweb1.man.ac.uk>
Sent: Wednesday, January 09, 2002 10:02 AM
Subject: Retro-Validation of Legacy Equipment
> Happy New Year to everyone.
>
> Here's a question which I originally posted at the beginning of December
> last year, but it seems no-one could help me with. I'm re-posting it in
the
> hope that someone has a bit of inspiration this year and is able to help.
> In anticipation........
>
> Is anybody aware of the current policy/attitude of the FDA towards
> retro-validation (or qualification) of legacy equipment?
>
> As an example, if a WFI system had been installed with no real
> validation/documentation, but was shown by the data to be performing
> satisfactorily, even if not designed and constructed to current "best
> industry practice", would it be acceptable to:
>
> - Collate any existing historic documentation (e.g. manufacturer's
> literature, materials certs, control system listings etc);
>
> - Ensure that drawings, descriptions, operation & control philosophy,
> critical equipment and instrument rationales etc. etc. are fully
> representative of the current system.
>
> - Ensure that a system of procedures, maintenance schedules, sanitisation
> routines, filter integrity checks etc. was in place to demonstrate control
> of the system.
>
> - Have periodic analytical data and plant performance review and approval.
>
> And in this way provide the required "documented evidence which provides a
> high degree of assurance that a specific process will consistently produce
a
> product meeting its predetermined specifications and quality
> characteristics" (quote from FDA guideline on process validation).
>
> I would appreciate any input, especially with reference to FDA policy
> documents, examples from actual inspections etc. The reason I ask is that
I
> have hear a rumour that "retro-validation is no longer permitted" and I
need
> a sanity-check.
>
> Thanks in advance.
>
> Kind regards,
>
> Ian Cook
> QA/Technical Director
> Honeyman Water Ltd
> Tel: +44 (0)1833 690101
> Fax: +44 (0)1833 690102
> www.honeyman.co.uk
>
>
>
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