GMPs in Early Development Series Published in Pharmaceutical Technology

November 5, 2012

Over the course of 2011-2012, the GMPs in Early Development Working Group authored a series of five position papers, published in Pharmaceutical Technology in 2012. The first article provides an introduction and overarching motivation of the GMPs in early development working group; subsequent papers address four areas where additional clarity is believed to be needed: Analytical methods, Specifications, Drug Product Manufacturing and Stability. More about the GMPs in Early Development Working Group