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GMP’s in Early Development Workshop a Success!

GMP’s in Early Development Workshop a Success!

March 26, 2014

On February 4 and 5, the IQ GMP’s in Early Development Working Group sponsored a workshop on phase appropriate strategies for drug product manufacturing drug substance and drug product analytical methods, stability and specifications. Over 75 industry and regulatory scientists and professionals converged on the FHI360 Conference Center in Washington, DC to discuss best practices and the application of GMP’s for small molecule drugs in early development.

In early development, the manufacturing process is not yet fully defined and the analytical methods are not yet fully validated. Therefore, the quality system implemented during early phase should take into account the likely process changes, in-process adjustments, specification changes, scope of the stability study and continuous development of the analytical methods as intrinsic to the work being performed prior to the determination of the final process and validation of the analytical methods during later stages of development.

This Workshop provided a broader public forum for further discussion of the application of GMPs in Early Development. As the Chair of the Workshop Planning Committee, John Skoug (AbbVie), stated, “the format of the meeting was rather unique – having presentations by industry and FDA speakers, and then following that with breakout sessions, all geared around the position papers we had written [in Pharmaceutical Technology] in 2012 was very effective at encouraging discussion and debate… I was also pleased to see that FDA speakers were highly engaged and participated in the breakout sessions.  I was thrilled at the open, constructive discussions between industry and FDA meeting attendees”.

Skoug also indicated an interest in future activities, saying that he hoped “this workshop will serve as a model for IQ to sponsor additional events like this on other topics of interest to IQ constituents”.


The IQ Consortium regularly sponsors workshops and webinars for working groups to share their accomplishments and collaborate with other industry and regulatory experts. Upcoming IQ events include a webinar by the Green Chemistry working group on April 25, and the CMC Summit in early June.