The International Pharmaceutical Excipients Council Federation, (IPEC Federation) announces the availability of the revised IPEC Excipient Information Package User Guide and Templates (EIP) (Version 4, 2020).
The guide was originally published in 2005, and subsequently revised in 2009 and 2013 and is widely used globally.
The primary goal of the EIP guide is to facilitate the excipient supplier’s sharing of information with the user in a standardized way rather than completing individual questionnaires and surveys.
The EIP consists of 3 different documents covering quality systems, product regulatory and supply chain and security:
• Product Regulatory Datasheet
• Site Quality Overview
• Supply Chain and Security Overview
Templates for each of these documents are available separately.
The guide will be available, initially exclusively to IPEC members for a three-month period, on the IPEC Federation and national/regional members’ websites. Thereafter, the guide will be made available to the general public.