IPEC Europe is the association that brings together producers, distributors and users of pharmaceuticals excipients. IPEC Europe counts 71 full members, 4 associate members and 5 co-opted members.
The team developed a ‘how-to’ document to explain the new requirements set by the EU Guidelines on risk assessment for excipients and to ensure that manufacturers and users of excipients have a common understanding of the objectives, tools and processes for the risk assessment.
The team works in collaboration with IPEC Americas and PQG to update the Good Manufacturing Practices (GMP) Guide published in 2006.
The team works on the implementation of the ICH Q3D Guidelines by reviewing any draft proposals issued by EDQM and/or EMA, monitoring and commenting on any outputs from the ICH IWG, working with sisters associations and IPEC Federation to ensure a consistent IPEC message, monitoring any developments in non-ICH regions.