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GMPs in Early Development Working Group

The GMPs in Early Development Working Group (WG) is a collaborative effort between the IQ Consortium’s Analytical and Drug Product Leadership Groups that is intended to inspire innovation and flexibility in early development (Phase 1 to 2a) through creation of guiding statements and best practices for GMP activities that are consistent with existing regulatory guidance and statutes. Our intention is to promote discussion and build alignment with internal stakeholders and regulatory agencies around these concepts. Improved clarity in definition of GMP expectations will lead to improved efficiency in early development while assuring product quality and patient safety. The scope has been purposely limited to small molecules intended for oral administration. However, it is believed the concepts can be extended to other dosage forms and entities (e.g. biologics).

GMPs White Paper Series in Pharmaceutical Technology

Over the course of 2011-2012, the Working Group focused its efforts on four areas related to GMP expectations in early development where additional clarity is believed to be needed: Analytical methods, Specifications, Drug Product Manufacturing and Stability. The group developed 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 cover each of the four areas mentioned.

This work was also presented to IQ Consortium members via a webinar on September 28th, 2012.