EMA Clarifies GMP Requirements for Herbal Substances Used as APIs

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What are the GMP requirements applicable to the initial extraction steps in the manufacture of herbal medicinal products? When does EU GMP Guide Part II apply? A new EMA Q&A document on GMP for herbal extracts used as active pharmaceutical ingredient (API) gives the answer to this question.

What GMP requirements apply to herbal extracts used as APIs?

The agency states that for the GMP classification, reference should be made to the table in EU GMP Guide Annex 7 (Manufacture of Herbal Medicinal Products) illustrating the application of GACP (Good Agricultural and Collection Practice) and GMP (Good Manufacturing Practice) to the manufacture of herbal medicinal products (HMPs). Thus, initial extraction steps in the manufacture of herbal extracts used as APIs should be carried out in compliance with the requirements of EU GMP Part II.

However, in some exceptional circumstances it is acceptable that the early manufacturing steps such as initial expression and distillation are performed in the field, "when they represent an integral part of harvesting to maintain the quality of the product within the approved specifications". In this case, appropriate documentation, control, and validation according to the GMP principles should be assured by the API manufacturer as part of its supplier qualification. Regulatory authorities may assess GMP compliance of these activities during inspections.

For more information please see the document on GMP requirements applicable to the early manufacturing steps for comminuted plants and herbal extracts used as active substances.