As product types become more complex, the increase in the levels of risk has led to increased regulatory surveillance of pharmaceuticals, the result of shoddy practices which, in the most extreme cases, have resulted in patient deaths. The regulatory agencies, led by the US Food and Drug Administration (FDA) and the European Medicines Agency (EU), are on the case more than ever.
The knock-on effect is that while more employment opportunities are being created for Quality Assurance (QA) experts, for example in Sterile Injectables, Biologics and Advanced Therapy Medicinal Products (ATMPs), the talent pool is much diminished. Many individuals previously focusing on lower risk products, don’t have experience of higher risk environments, so there’s a real dearth of experienced talent in Good Manufacturing Practice (GMP) compliance at these levels.
Lean model, robust quality
Those companies with the highest levels of GMP compliance usually run a leaner staffing model governed by robust quality assurance principles and a Quality System that is not over-complicated. The staff in these firms truly believe in quality and are compensated to reflect this level of professionalism and belief. To have a great quality team, you need to ‘overhire’ within a lean quality system model; in other words, make sure you have the right talent but don’t overdo the bureaucracy or the effectiveness of the Quality System will be greatly reduced.
The need for experienced talent is more important than ever given that the audits are far more thorough nowadays – e.g. teams of four FDA inspectors (Consumer Safety Officers) are sent over a two-week period for one site – and the level of expertise they bring with them is more specialist than a few years ago. Very rarely will a company pass all the criteria. Yet while clamping down on regulatory laxity is to be commended, especially with patient safety in mind, it’s making it harder for organisations to keep up with regulatory demands.
Companies that cut corners (and costs) in the level of competence of their quality assurance talent will pay the price. Quality must not be perceived as a cost but more as an integral part of the commercial process. The cost of product recalls or country bans are far more expensive and will hit the bottom line egregiously. Global Heads of Quality must do all they can to attract and retain these professionals, continually reviewing the regulatory expertise they need.
It’s a challenge but ultimately you can’t scrimp on quality. Those frequent cGMP Warning Letters will serve as timely reminders. It really is all about quality in the end. Without that you don’t have too much.
As always: thanks for reading. I’d love to hear your thoughts so please get in touch with me at timothy.walker@gxpeople.com.