NSF grooms manufacturers for global commerce

The new program, called GMP 9000, rolls together GMP and ISO 9001 registrations into just one audit.

In Europe, greater credence is given to ISO 9001 standard, which is an audit of management systems and documentation. It requires employees to be trained and manages conditions were work is done, but sets out just 25 requirements for process control and none for sanitation.

GMP standards, on the other hand, which are favored in the US, include 45 requirements for process control and 16 for sanitation. It is much more of a facility-focused processes, addressing factors such as lighting and filtration and requiring employees to report adverse medical conditions.

One thing that the US and Europe do have in common, however, is that quality expectations are becoming ever more stringent.

"Finished goods companies don't want to take on the responsibility of poor quality ingredients,"​ NSF's Christopher Steele told NutraIngredients-USA.com. "People are looking for quality further and further down the supply chain."​

The introduction of cGMP (current good manufacturing practice) guidelines in the US, expected to be published by the FDA this year after more than a decade in the works, could throw up problems for companies that have, until now, been able to get away with systems that are below par.

Their imminence has been lauded by the supplements industry, whose reputation as a whole would be at risk if just one member caused illness or injury to consumers through poor manufacturing practices.

Many see them as one of the final pieces of the DSHEA (the 1994 Dietary Supplements Health and Education Act) puzzle that must fall into place before the Act is considered fully implemented.

In the face of this changing landscape in the US, Steele advises companies to heed their inner boy scout and be prepared: "If companies wait until the last moment before the GMPs are introduced, it could cause real disruption to the supply chain,"​ he said.

But in the ten years since the act was passed, industry has adopted a much more global outlook, and for companies wishing to do business in Europe adherence to the GMP standards, even if proved through regular audits, may no longer be enough.

While in the past European companies could reassure their European customers by having ISO registration in place, and US companies their US customers with GMP, once they start crossing over into each others markets they may be regarded as not up to scratch if they don't have both systems in place, warns NSF.

Steele explained that the cost of ISO registration is determined by the number of employees. A company with 150 employees would pay between $17,000 and $20,000.

GMP registration is based on the size of the facility in square feet, and may cost between $8,000 and $10,000.

With GMP 9000, the same company would may between $25,000 and $35,000 for both systems.

Steele added that the indirect savings of carrying out two audits at once are also significant, as manufacturing is interrupted only once.

Audits are carried out twice a year in order for accreditation to be maintained.