Quality Working Party questions and answers on API mix - Scientific guideline

This guideline applies to human and veterinary medicines.

This document provides information on how to deal with mixtures of active pharmaceutical ingredient and excipients (called API mix).

Keywords: Active pharmaceutical ingredient (API), API mix, excipients

Current version

Quality Working Party questions and answers on API mix

Reference Number: EMA/CHMP/CVMP/QWP/152772/2016 Summary:

These Q&A have been developed to provide information on how to deal with mixtures of API and excipients (called API mix), and to identify situations where it will be acceptable to use the ASMF/CEP procedure and perform manufacture under EU GMP Part II for the API mix.