EMA releases final guidance on avoiding herbal medicine contamination

Final guidance on avoiding contamination of herbal medicines has been released by the European Medicines Agency (EMA), which says final testing alone is not enough to guarantee quality. It said anti-contamination controls 'should be built-in the entire process, from starting material to finished product. Minimising and testing/monitoring of microbial contamination and mycotoxins in herbal substances, preparations and medicinal products must be based on a case-by-case risk assessment'.

EMA says a series of potential contamination points need to be considered by manufacturers. These include sourcing herbs, deepening knowledge about related micro-organisms, manufacturing processes, decontamination procedures, ensuring purity of excipients, packaging, dosage forms, administration routes, posology and patient groups.

'Most importantly, preventative measures are preferred rather than interventions for decreasing the contamination,' the Agency said. Indeed, compliance with good agriculture and collection practices (GACP) and good manufacturing practice (GMP) throughout the entire production process 'is crucial,' said the guidance. It said resulting products should not promote microbial growth, and controlling drying/water content are 'critical parameters'. Meanwhile, if manufacturers use a decontamination system, they need to ensure that it does not change the chemical composition of the herbal material or leave fresh toxic residues.

Tests for total aerobic microbial count (TAMC) and total combined yeast and mould count (TYMC) should be undertaken, added the guidance.