An Integrated Approach to the Preparation of Global CMC Dossiers

Abstract

The rapid review and approval of global chemistry, manufacturing, and control (CMC) dossiers requires that technical and managerial staffs in research, project planning, regulatory affairs, manufacturing, marketing, quality assurance, and information management work together in a high-performance team environment. To produce a successful dossier, these groups must coordinate their efforts to synchronize a complex array of format and content considerations. A unified vision of CMC will help the CMC dossier group reduce cycle times associated with dossier creation and review. This vision integrates important concepts including: modular design of information, work teams, style guides, educational programs, project planning, the electronic environment, and structured review of dossiers. If a pharmaceutical company successfully implements this vision, its reward will be a CMC dossier that regulatory agencies will review rapidly with a minimum of regulatory questions.