To your question, the only study I have ever heard of along these
lines was at a major pharmaceutical company in Connecticut. At a
conference I attended, a speaker referenced a CSV effectiveness
review which showed that validated and unvalidated systems failed at
exactly the same rates.
Of course, this can all be rationalized away as the result of poor
validation. My earlier post on this thread goes to this very point-
that the vast majority of our industry’s efforts in this area are
wasted. Trivia such as document formatting and enforcing rigid
compliance with SOPs (that were poorly written in the first place)
seem to matter more than patient health and safety.
Indeed rigid compliance with GAMP or guidance documents (written by
FDA personnel who clearly have very limited experience with the
subject matter) seems to have become the goal. “Compliance over
quality” is strangling the industry.
I can immediately think of 2 situations within the last year where a
client has continued with (or implemented) a manual process to avoid
the perceived difficulties of CSV. The risk of error is massively
higher with the manual process rather than via an automated system.
Yet- CSV is seen as too time consuming and too expensive.
How did we get here? How do we get better?
The FDA itself bears much of the blame. The entire Part 11 debacle
is symptomatic of the problem. Ill considered and poorly written
regulations (clearly designed for only a narrow subset of the
systems covered within its scope)- are supported by even less
helpful guidance documentation.
A review of warning letters would seem to indicate that the agency
only slams those where they find evidence of widespread quality
systems failure. Failure to validate your Visual Source Safe
application? I haven’t seen that one. Failure to use the correct
corporate template to present the necessary data? Nope- haven’t
seen that one either.
The FDA has very little incentive to clarify matters. All of the
over-shoot in compliance efforts can easily be misconstrued as being
better than just making it over the bar.
For manufacturers, the consequences of compliance failure (in terms
of 483s, commercially, and to a manager’s career) are massive. Risk
based validation is generally failing because the agency encourages
with its publications, but fails to do enough to alleviate fear.
(Are there enough people at the agency who understand the subject
well enough to really comment?)
The industry itself has failed to infuse its culture with sufficient
understanding and knowledge to make informed judgements. So- staff
who feel that they lack sufficient knowledge either hire consultants
(who often lack sufficient hands-on experience themselves) or just
take a “do everything” approach to minimize the risk that they will
get fired for making a mistake.
How many times have we heard presenters giggle through a training
session “… of course, it is always good to have your validation
binders make a big thud when you drop them on the table…” If it
is true that inspectors are more impressed by countless reams of
paper over a more thoughtful but “light-weight” alternative… then
we are all in a lot of trouble.
Both the agency and the industry must go back to basics. Less
prescriptive solutions, fewer (but more useful) SOPs- and more of an
emphasis on quality. (How many people in the industry use
statistics for anything other than product inspections? If CSV is
so important, surely it too merits measurement?)
The last part of this polemic addresses a sensitive subject:
validation and quality people. As a profession, validation and
quality often attract people who are obsessed with detail. In the
right measure this is no bad thing. However, the industry is awash
with people who cannot see the wood for the trees. Some were drawn
out of interest, others will have been pushed out of operations
roles where they were seen as slowing everything down. Validation
and quality can (and do) grind many perfectly good projects to a
halt simply out of nit-picking. Managers need to ensure that they
have the right mix of personalities to ensure that something as
important as drug/device quality does not become a dumping ground
for the obsessive-compulsive.
Please be in no doubt- I am not arguing for less quality assurance.
I am just pleading for an intelligent approach.
