At first glance, the title of this article may bring a wry smile to the face of many an astute practitioner, but I can provide
'documentary evidence' that free validation is not a just a play on words, but a financial reality.
Flawed philosophies
As a seasoned lecturer in validation and compliance, I welcome novel ways of explaining what validation and, more generally,
compliance are; how they affect a company; and how best to implement them. Fundamentally, as a pharmaceutical facility embarks
on a validation initiative, or rather the overall pursuit of regulatory compliance, projects can easily become lost in the
detail and, consequently, lose sight of their true objectives. All too often, personnel put their energies into 'doing things
right' and, while this may seem commendable, on closer inspection it can be found wanting. I have found this embraced in companies
as part of policy, but these flawed philosophies can manifest as problems almost anywhere in the business. Unless the company
has the evidence to back up such claims, regulators will know exactly what to challenge and where to expose these shortcomings.
Doing things right is also often extolled as the rhetoric in training sessions and project meetings without consideration
of the huge costs and burden of both the validation effort and the remedial tasks in the infrastructure required to support
them. Often we find investment in both is disproportionate to any returns, making it no small wonder that validation is still
regarded by many with great suspicion. Practitioners have also opined at conferences that it adds no tangible value to their
business, but why is this misconception still prevalent? Why are there still so many misunderstandings surrounding validation
and what constitutes full compliance with, for example, FDA and the Code of Federal Regulations (CFR)? One answer is that
we should all ponder less about 'doing things right' and think more objectively about 'doing the right things', otherwise
we may find that we have elevated the entire operating parameters of the business to a level it cannot afford, is ill equipped
to develop and incapable of sustaining. Conditions
There are conditions to achieve 'free validation'. First, financing a major validation project requires substantial capital
outlay and is a daunting task for all concerned. When validation is placed alongside the daily running of the business, cultural
resistance is inevitable and someone will invariably ask: "Why do we have to do this?" The point they should be making is
that it is not part of their job description, contract of employment or day-to-day duties; in fact ,the extra work is more
often a substantial departure from the daily continuity that keeps the business going.
As the intensity of a project builds, so too does the pressure on those in key positions, which contorts the point of compliance
from one of substantive inconvenience to a general feeling of upheaval. Add to this the barbed comments between colleagues
during monthly project budget reviews, where disparities between project outlay (finance) and progress become all too apparent,
and validation becomes even more controversial. Management has every right to feel prickly as the costs and business risks
are enormous — get it wrong and you compromise product quality, patients' health and the company.1
As the funding dries up, corners are cut, strategies are reinterpreted, assumptions are made and the whole experience of striving
for regulatory compliance begins to fall apart, if not overtly, covertly in private memos and closed door tête-à-têtes. In the end, the red ink is slashed all over what is left of the budgets, but what has really happened is that the business
risk has risen and placed the company at the mercy of the thoroughness of regulatory bodies. But maybe the business will get
lucky? Maybe they will not notice that policies and key procedures are not followed and that things have not always been documented.
If there is a version of Russian roulette in the pharmaceutical business, this is it. Symptomatic of a business tumbling toward
critical and major observations, the condition is known as 'quasi-validation.'2
Keeping it simple is key, but this is easier said than done. Keeping the costs of validation and compliance to a minimum would
keep many happy as it would lessen the work load across the entire organization, freeing us to do what we do best — make the
finest medicines and devices in the world.
