GMP-IPEC

The IPEC Federation is a global organization that promotes quality in pharmaceutical excipients. The IPEC Federation represents the five existing regional International Pharmaceutical Excipient Councils (IPECs) – IPEC-Americas, IPEC Europe, IPEC Japan, IPEC China and IPEC India – and provides a unified voice to promote the best use of excipients in medicines as a means of improving patient treatment and safety.

Excipients play a critical role in the manufacture of medicines by helping to preserve the efficacy, safety, and stability of active pharmaceutical ingredients (APIs), and helping to ensure that they deliver their promised benefits to patients.

Optimal use of excipients provides pharmaceutical manufacturers with drug development cost-savings, enhanced functionality capability and can also assist in drug formulation innovation.

The IPEC Federation and PQG have updated the IPEC-PQG GMP Guide, bringing the document in line with the latest thinking on Good Manufacturing Practice requirements for pharmaceutical excipients. The Guide needed to be updated to take into account the EXCiPACT and ANSI standards, against which excipient suppliers can be certified to provide assurance that they are operating in conformance with excipient GMP.