Time, attention and more resources must be devoted to meeting new standards, experts warn
United States The contaminated heparin affair (see previous page) arrived just months before implementation of the FDA's new Good Manufacturing Practices (GMPs) regime, which will oblige manufacturers to document, among other things, the sourcing of their ingredients.
Enforcement will be phased in according to company size. On June 25, companies with 500 or more employees, excluding contractors, will be brought into the regime. A year later, companies with fewer than 500 employees, but more than 20, will be included. And on June 25, 2010, the rules will apply to companies with fewer than 20 staff.
Andrew Shao, vice president, scientific and regulatory affairs at the Council for Responsible Nutrition, said the heparin episode has illustrated just how valuable the new system would be for manufacturers of dietary supplements. "The GMPs for dietary suppliers require that companies test all of their incoming ingredients for identity, so that they can be sure that they are what they say they are," he said.
However, meeting the ingredients-related requirements of GMPs is no simple task, requiring time, resources and expertise, experts warned. Ed Wyszumiala, new account manager for NSF's dietary-supplements programmes, described the new regime as a "very document-intensive regulation."
"GMPs compliance will take time, effort and investment," he said. "The more paperwork you do, the better. How did you qualify the supplier? You should have a Standard Operating Procedure in place, so you can show the FDA how you did it. If you don't document it, it doesn't exist."
It won't be enough to simply trust your direct suppliers, according to Tony Young, general counsel of the American Herbal Products Association. "Reliance on Certificates of Analysis just isn't going to fly. You need to protect the integrity of your materials. You're going to want to go back to suppliers, on through the major ingredients wholesalers in the US, and try to establish whoever is supplying ingredients to them is qualified as well."
"You are going to need more personnel," said Bryon Johnson, nutrition-industry relations director at contract-manufacturing services provider Access Business Group. "These people don't report to the head of manufacturing — that's a conflict of interest. You need a separate management stream of qualified quality-control people."
W H Leong, vice president of functional-ingredients supplier Carotech, said GMPs were not straightforward to implement but offered long-term benefits. "It entails setting up a whole new quality-assurance team to ensure compliance, as well as continuous education of each and every employee in the organisation.
"However, once the system is in place, in the long run GMP practices will actually reduce the cost of production as they result in intensive checking, which minimises rejects. The fundamental basis of GMPs is to operate a company in a 'state of control,' to prevent contamination, mix-ups and errors which ultimately increase production costs."