Finzelberg gets first GMP cert for plant actives

Related tags Quality assurance

German firm Finzelberg is the first plant extracts producer to gain
GMP certification under new European rules for active agents in
pharmaceuticals, it said this week.

The company, which gained the certification for good manufacturing practice (GMP) around six months ago, is also a leading supplier to supplement makers, particularly on the German market where supplements are often regulated as OTC pharmaceutical products.

The certification will also be of interest to companies working in markets that regulate supplements as food. Formulating with plants produced under GMP conditions reflects a higher level of quality in the finished product, and will allow supplement makers to demonstrate a quality level that ranks alongside that of pharmaceuticals, said Dr Carolin Notheis, production manager at Finzelberg​.

"For supplement makers it will be easier to justify prices based on the quality that this certificate demonstrates. I think they can put their products in line with pharmaceutical ones if that's important to them,"​ she told

GMP certification reflects consistent quality standards in production, technology and quality control. GMP standards have long existed for pharmaceuticals but were only introduced last year for active agents. Outside of the European Union, these GMP regulations are known as the ICH Q7A standards, recognized by Europe, Japan and the US.

Several chemical firms have already gained GMP certification for their actives but Finzelberg claims to be the first of Europe's plant active manufacturers to complete the expensive process.

The firm, part of the Martin Bauer group that also sells extracts to food and beverage makers through its Plantextrakt business, has had a quality management system certified under ISO-9001 standards in place since 1996, and for many years has had an official production permit for pharmaceuticals.

In foreign countries, however, the German permit is relatively unknown.

"At least two people have worked full time for two years on this, and our whole quality system,"​ Dr Notheis explained.

"We already had a system in place, but needed to make it fit with the new regulations."

More than 100 of Finzelberg's GMP certificates have already been ordered by customers to be included in their product registration dossiers, a sign of the recognition given to GMPs in the industry.

Dr Notheis added: "This is not a prerequisite for actives in supplements. But from experience we know that standards from pharma are often taken on by the supplements industry a few years later. This might be the first sign of such a move for the supplements sector."

In the US, the Food and Drug Administration is set to introduce GMPs for dietary supplements this year, although the timeframe is still vague, having been drawn out over years. The proposed rules focus on the quality of finished products, however industry associations have been pushing for changes to include testing of ingredients, including plant extracts, in order to better reflect overall quality of a product.

Related topics Regulation & Policy Suppliers

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