In the fast-growing nutraceuticals market, rules are becoming stricter too. Authorities in Scandinavia are clear that if nutrition companies are going to start making medicinal claims about their products, they must categorise themselves as pharmaceutical businesses and be bound by similar requirements. And countries from Japan and India to Canada have already put the regulatory wheels in motion.
Pharma has come a long way in refining its processes and harnessing technology to streamline workflow and tighten up reliability, so as an industry it provides a valuable reference point. One of the techniques a lot of companies here have adopted is an automated approach to label checks, using sophisticated text verification – a process which can very quickly pick up even the tiniest discrepancies between regulatory text, artwork briefs and packaging artwork, irrespective of the font or language in use. Although humans should never be distanced entirely from critical checks, using reliable automation can save on several rounds of laborious proofreading and accelerate time to market, freeing up skilled resources for more specialist work.
Manual tasks are unrewarding, demotivating and a poor use of qualified professionals’ time. So it is far from ideal that the life sciences industry is using scientific writers with PhDs to check over content for regulatory/QA purposes, at great expense to the business. Avoiding a product recall or safety scare is clearly in everyone’s interests, but there must be a better way.
Even without the implications of Brexit, these are turbulent times for regulatory teams. Compliance has become a full-time job, and administrative demands are on a permanently upward trajectory.
Regulatory requirements are increasing all the time in life sciences, and recently it has seemed as though the rate of release of new guidelines and directives is accelerating.
