GMPs are necessary, but they only scratch the surface of supply-chain security
UNITED STATES Responsible companies that partnered with third-party certifiers to implement GMPs before the official FDA regulations finally arrived are finding themselves mostly better than GMP-compliant, but only slightly closer to being confident in the quality of their products.
"The recent GMPs were much more lenient than I would have expected," said Darryl Sullivan, senior manager of food and drug analysis at Covance, which provides testing and analytical services to the industry. "A year ago I would have told clients to expect to have to do more testing and expect to have more documentation than is really technically required in the GMPs as they were published. It doesn't hurt to still do that, because most of the FDA auditors that are going to be auditing under dietary supplement GMPs have a pharmaceutical background."
GMPs may dispel the popular myth that the supplements industry is unregulated, but in reality it is only a single government regulation, and many more individual corporate quality-control initiatives must be undertaken to ensure quality products. Third-party testing labs such as NSF, Shuster and USP help. Industry trade groups are also pitching in. Ultimately, though, it comes down to corporate responsibility.
"GMP compliance may not be enough," said Phil Katz, senior vice president of Shuster, which provides testing, audit, inspection and responsible sourcing services. "We're going to have to rely on ourselves." He said companies need to coordinate GMPs with plant inspections and sample testing, a traceability programme, an HACCP (hazard analysis and critical control point) review to identify potential safety hazards and prevent problems, a sampling plan, and more.
"If you have an HACCP programme, don't trade with a company unless they have an HACCP programme. And so on down the line," said Katz. "Where do you get your chondroitin? It comes from cattle trachea. It gets into a manufacturing plant. Then to another plant and purified. Then it's sold, based on purity. You drill down as far as you can go on the supply."