EU GMP Annex 7 - Manufacture of Herbal Medicinal Products

What it says

Manufacture of herbal medicinal products requires GMP principles adapted for the inherent variability of plant-derived starting materials, including specific botanical identification and authentication requirements, control of agricultural and environmental contaminants such as pesticide residues and heavy metals, and processing controls addressing the natural variability of herbal source material.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• Herbal starting materials present a distinct quality challenge given their natural, agricultural origin, requiring specific botanical authentication to confirm the correct plant species and part was actually used, beyond what chemical identity testing alone might confirm.
• Contaminant control for herbal materials must address agricultural and environmental risks, pesticide residues, heavy metals, microbial contamination from growing and harvesting conditions, that have limited parallel in synthetically manufactured active pharmaceutical ingredients.
• Natural variability in herbal starting material composition, arising from growing conditions, harvest timing and geographic origin, requires manufacturing and control strategies specifically designed to manage this variability rather than assuming the consistency typical of synthetic starting materials.

What inspectors look for

• Whether botanical authentication of herbal starting materials genuinely confirms correct species and plant part, beyond generic chemical testing alone.
• Whether contaminant testing adequately addresses agricultural and environmental risks specific to the herbal material's growing and harvesting origin.
• Whether the control strategy accounts for natural batch-to-batch variability in herbal starting material composition, rather than assuming synthetic-material-level consistency.

Related regulations