The Food and Drug Administration (FDA or Agency) just announced today the availability of a draft guidance for industry entitled “Q3D(R2)—Guideline for Elemental Impurities.
Workshops: September 27
Conference & Expo: September 28-29
An overview of IPEC-Americas activities for the year 2020 has now been published!
The IPEC Federation announces the availability of a new position paper, "Pharmaceutical lactose used in oral preparations is a low-risk excipient".
The IPEC Federation announces the availability of the revised and updated IPEC General Glossary of Terms and Acronyms for Pharmaceutical Excipients (Version 2, 2021).
When an on-site audit is not an available option, this IPEC-Americas position paper provides potential alternatives that may be appropriate, when adequately supported by a risk-based approach.