IPQ is pleased to provide the IPAC-RS community with a complimentary download of our April 2011 Monthly Update, covering the important CMC and GMP developments during the Month of April. The issue includes two stories that we think you will find of particular interest stemming from presentations and discussion at the IPAC-RS Conference in April:
● One of the stories focuses on a discussion by the Supplier Quality Working Group chair Barbara Falco’s on the consortium’s effort to drive forward the implementation of the IPAC-RS GMP guidelines for OINDP component manufacturing and supply – including the work with UK’s Pharmaceutical Quality Group (PQG) to extend the reach of its global PS-9000 certification standard into the inhalation arena.
● A second story in our Monthly Update for April addresses thought-provoking presentations by Ron Kaye, who leads the CDRH’s Human Factors and Device Use Safety Team, and Pfizer’s Paul Lucas on the industry/regulator dialogue on developing a viable approach to HF/usability analysis for combination products in the US and Europe.
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Download the April issue here