EMA Adds Use of Peptones in API Manufacturing to Q&A Guidance

The European Medicines Agency (EMA) updated its Q&A on drug quality to address the use of peptones in manufacturing APIs.

The agency says the source of any peptone used in the fermentation process during API production must to be included in any active substance master file, certificate of suitability and marketing authorization dossier if relevant.

Any fish peptone used in the fermentation process must be included in the active substance’s specifications, as the fish may be contaminated with histamine and pose a potential threat, the agency says.