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.

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.