Chemistry, Manufacturing, and Controls 2012 Summit
The IQ Consortium’s CMC Leadership Groups met in Chicago on June 27, 2012. The objectives of the meeting were to discuss the IQ CMC strategic plan, introduce the recently-formed IQ GMP QA Leadership Group and agree on draft strategy and expectations for potential cross-disciplinary CMC Working Groups. Some existing Working Groups also had an opportunity to meet during the Summit and report on their accomplishments and plans.
Participants were introduced to the IQ Strategic Plan, and discussed several topics including review of manuscripts, communications strategies and communications materials, participation in working groups, engagement of regulatory colleagues, and the inclusion of Biologics into CMC. In addition, they received an introduction from the chair of the GMPQA Leadership Group, and discussed the draft problem statement of the three potential cross-disciplinary projects: Process Validation, Implementation of ICH M7, and Elements of a Quality Organization. Some existing Working Groups (Contract Manufacturing, QbD-API, QbD-DP, Extemporaneous Formulation and Counterfeit Detection) also met to review their recent accomplishments and discuss next steps.