The IPEC Federation has issued a position paper titled Good Manufacturing Practices for Atypical Actives. The purpose of the paper is to advocate for appropriate GMP for certain materials used as atypical actives in drug products based on risk assessment, rather than ICH Q7 GMP compliance or its equivalent.
A general background regarding the differences between Atypical Actives and Active Pharmaceutical Ingredients (APIs) is included, along with their typical characteristics and the various uses of these materials. Current regulatory perspectives on this subject from the European Union, United States, Canada and Brazil are provided. The paper proposes that a harmonized approach should be established across global regions outlining key principles manufacturers, users, as well as regulatory bodies and compendia should use when addressing this topic.