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More GMP third party services crop-up

By staff reporter, 10-Jul-2007

Related topics: Industry

One of the first companies to offer GMP audits has stepped forward to promote its services for dietary supplement manufacturers wanting to make sure they are in line with federal regulatory requirements.

Global Lifescience Solutions (GLS), an NSF International Company, performs preliminary audits to ensure a facility is in full compliance with GMPs. Good Manufacturing Practices (GMPs), which some say is the most important regulatory development for the dietary supplement in over a decade, were recently issued.

The emergence of the GMPs, and the fact that they are set to come into effect, has given third party services the go-ahead to promote their services and help manufacturers make sure they clean up shop in time for their respective deadlines.

Those companies with more than 500 employees will have until June 2008 to comply, while those companies with less than 500 employees have until June 2009 to comply. Finally, those with fewer than 20 employees have until June 2010 to comply with the regulations.

A statute of the 1994 Dietary Supplements Health and Education Act (DSHEA), GMP legislation has been the missing link in governance of the dietary supplement industry. The legislation is set to provide standards specific to this industry for inspectors to check for purity, safety and legality in manufacturing.

The rule applies to companies - domestic and foreign alike - that manufacture, package, label, store and distribute dietary supplements in the US.

"Our goal is to help manufacturers improve their quality programs from initial implementation to ensuring ongoing compliance," said Aline Lindbeck, general manager of GLS.

GLS is a contract research and consulting firm that provides a wide array of services to the dietary supplement and pharmaceutical industries, including risk assessments, efficacy testing and label reviews. It will offer these services for GMP preparation along with its preliminary audits.