FDA melamine guidance needs revision, says Hovione CEO

The US Food and Drug Administration's recent guidance on screening pharmaceutical ingredients and components for melamine contamination is too broad in its approach and will create a huge burden for suppliers.

That was the message delivered by Guy Villax, chief executive of Portuguese active pharmaceutical ingredient (API) manufacturer Hovione FarmaCiencia at a press conference held during the Conference on Pharmaceutical Ingredients (CPhI) in Madrid, Spain, last month.

Last year, around 300,000 children in China were poisoned by deliberately falsified milk and milk products containing melamine, with more than 290,000 falling ill, around 52,000 requiring hospitalisation, and at least six deaths.

In this case, melamine (pictured) was deliberately added to milk-powder products in order to fool the assays for nitrogen, which are used as marker for protein content and a guide to the quality of milk products.

In August, the US Food and Drug Administration (FDA) brought out guidance for industry on the 'components at risk' of contamination with melamine. The document is open for comment and can be downloaded here.

As it stands the guidance is going to be tough for industry to follow, said Villax, because the definition of an at-risk component is so broad.

"Any active ingredient or excipient, or any raw material that goes into an active ingredient, or excipient, can be considered at-risk if two conditions are met:  the component relies on a nitrogen test for identification, and if it has more than 2.5 per cent content of nitrogen," Villax told the press conference.

He said the situation was similar to the concerns about transmissible spongiform encephalopathies (TSEs) which swept through the industry in the 1990s in the wake of the concerns about 'mad cow' disease which affected the UK and other countries.

"We are going to be bombarded by customers asking for certificates that you have no at-risk components in any API you supply," said Villax.

"This means a ton of work that - between technical people - can be considered completely useless."

Industry bodies, including the International Pharmaceutical Excipients Council (IPEC), the Society of Chemical Manufacturers and Affiliates (SOCMA) and others, recently met with the FDA in order to raise their concerns and discuss ways to improve the guidance.


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