Companies face GMP time crunch

Many supplements suppliers have waited too long, experts warn

Many mid-sized dietary-supplements suppliers are late in coming to grips with the deadline for complying with the new GMPs, experts warn.

Companies with fewer than 500 employees, but more than 20, must comply with the new GMP (Good Manufacturing Practice) regulation by the end of June, after which they face the prospect of an inspection by the Food & Drug Administration. The law is designed to ensure the ingredients used in supplements are safe and unadulterated.

But with just weeks to go before this cut-off point, those whose role it is to help companies gear up for the new regime have told Functional Ingredients they believe some companies have failed to take enough, or even any, action to achieve compliance.

"We've been marketing to companies — sending emails about the timing of the deadline," said Michael Plover, president of Pennsylvania-based Quality Systems Design, a consultancy specialising in GMP compliance. "From the questions we're getting, it seems that some are just starting to get serious about it now."

And this, Plover warned, will be a problem. "It's too late. A number of companies have very few SOPS [Standard Operating Procedures, required for GMPs]. It would take about a year for those folks to write the SOPS, implement them, and get them up and running. Most of these companies are already manufacturers so they do have systems in place. But they are not as formalised or documented as they need to be."

Plover's concerns are shared by Elan Sudberg, lab manager at Alkemists Pharmaceuticals, a California firm offering dietary-supplements companies raw-material testing services for GMP compliance. "There are hundreds of companies that should be knocking down my door right now," he said. "But I think a lot are just waiting to see how enforced GMPs will be."

Sudberg believes the cost of complying lies at the root of this attitude. "They're just trying to save money. We've had several customers tell us our prices are expensive. But companies could be compliant without breaking the budget."

Michelle Gayeski, a GMP expert at Washington DC-based law firm Venable, said: "You have clients you don't hear from for a while and you think: is it because they are busy implementing GMPs, or because they are ignoring them?"

Gayeski said she hopes her clients fall into the first category. But she fears some may fall into the second, adding: "If the FDA were to show up on their doorstep, there would certainly be a problem. It's worrying."

Companies who do receive a visit from the FDA before they have complied with the GMPs are most likely to be issued a 483 Notice listing violation, which they are expected to rectify. Plover warns that companies who receive a 483 Notice expose themselves to the risk of more FDA inspections in the future. "You're on their radar," he said.

More serious breaches can result in companies receiving an official warning letter, which will also be posted on the FDA's website for all to see. Failure to respond adequately to a warning letter can lead to seizure and recall of raw materials and products, and even court action to prevent a company selling its products.

So what should companies do if they have waited too long? "They should do a gap analysis to see exactly where they are, and put together a formal, documented written plan as to how they'd like to get into compliance," Plover said. "If they get inspected by the FDA prior to their being in full compliance, at least they have a written plan they can show the agency."

Gayeski's advice is more blunt. "Call your attorney right away," she said.

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