The EMA wants manufacturers using herbal starting materials to assess the substances’ initial and post-processing contaminant profile.
Clarification of European Medicine Agency (EMA) requirements was given in an update to its drug quality question and answer document. The response details what steps manufacturers should take to control the quality of herbal starting materials used in the production of semi-synthetic actives.
“Starting materials of herbal origin should be characterised to ascertain their suitability and a contaminant profile should be established and submitted”, the EMA wrote . Manufacturers should consider the number of chemical steps between the starting material and the semi-synthetic active.
Potential contaminants of herbal starting materials include heavy metals, microbes, residual solvents, pesticides, and radiation. The EMA advises industry to follow the principles outlined in the European Pharmacopeia monograph on herbal starting materials when assessing quality.
Contamination concerns extend beyond the first tests of the starting materials. Manufacturers must check if contaminants survive the extraction and purification processes, the EMA wrote, and take appropriate actions.
Industry can use information about the origin, collection, and post-harvest treatments to justify their contamination-testing programme. Companies should also specify the scientific name of the plant, which parts were used, and the solvent used for the first extraction.
Microbial quality control
The EMA also addressed the update to microbiological testing methods for non-sterile products that brought Europe in line with the ICH (International Conference on Harmonisation). Harmonising the requirements made previous EMA advice and the regulator has now updated its recommendations.
“Any changes should be clearly identified in the variation submission and the affected parts of the marketing authorisation dossier should be appropriately updated, including a description of how the method is applied to the specific product”, the EMA wrote.