On 1 September 2008, the European Commission published the revised Annex 7 to the EC GMP Guide titled "Manufacture of Herbal Medicinal Products". The revision of Annex 7 was necessary in order to adapt the general GMP regulations on active pharmaceutical ingredients (Part II) specifically to the manufacture of herbal medicinal products. Further changes refer mainly to the new Directive 2004/24/EC on traditional herbal medicinal products.
The starting material for the manufacture of herbal medicinal products is either a medicinal plant, a herbal substance or a herbal preparation. The revised Annex 7 applies to all of these herbal starting materials.
The text emphasises that it does not deal with good agricultural and collection practice, which is described in the HMPC guidance document: "Guideline on Good Agricultural and Collection Practice for starting materials of herbal origin" (GACP).
Some steps in API production, like cultivation, collection, harvesting, cutting or drying, are not subject to GMP, but to the GACP regulations - as long as these activities take place in the field. To all further steps of cutting and drying, the GMP rules are applicable. A table assigns the individual activities to the applicable Good Practice regulations (GACP, EC GMP Guide Part I, EC GMP Guide Part II).
Further topics of the new Annex 7 are:
The complete document can be found here.
The document comes into force on 1 September 2009.
Dr Günter Brendelberger
On behalf of the European Compliance Academy (ECA)