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Nutraceuticals Production Standards

In many aspects, nutraceutical products fall halfway between pharmaceuticals and food. They are very similar to medical products in terms of their formulation and presentation, but to all intents and purposes they belong to the food goods category.

There are several standards that need to be observed if one wants to maintain quality production of these products. From a quick perusal of the list of standards that govern this sector, one fact immediately emerges: there is no specific set of rules - such as the Good Manufacturing Practices (GMP) for pharmaceuticals - specifically drawn up for the production, packing and preservation of nutraceuticals.

In fact, when it comes to the production and control of nutraceuticals, operators in this field must adopt the 'horizontal' rules applying to the food sector (in their widest sense), plus the HACCP self-control and monitoring rules regarding the hygiene aspects of processing and - on a voluntary basis - the ISO quality management systems, though there are no sector-specific systems.


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By Dr Cesare Dognini, Quality Assurance Manager at Fine Foods NTM S.p.A. Dr Cesare Dognini graduated in Pharmaceutical Chemistry and Technology. He has been working in pharmaceuticals for more than 14 years in production, quality control and quality assurance. Cesare is currently the Quality Assurance Manager at Fine Foods NTM S.p.A., an Italian contract manufacturer of pharmaceutical and nutraceutical products.
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Dr Cesare Dognini
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