Organization and Responsibilities of the Chemistry,Manufacturing,and Controls Function within Regulatory Affairs: A Survey of 17 Companies

Abstract

To facilitate management of the technical and regulatory Chemistry Manufacturing and Controls (CMC) issues within core dossiers, companies have turned to a range of organizational structures and procedures to manage the input most effectively. The objectives of this survey were to identify how companies have organized to provide regulatory strategy for the CMC sections of dossiers and to assess how, on a global basis, CMC documentation is created and reviewed. Seventeen of the top 30 United States- and European-based pharmaceutical companies participated in the survey.

While no structure provides the perfect answer to neatly balance all of the conflicting forces in the CMC document development process, the survey identified several factors which appear to lead to successful performance. Strategy development for CMC issues should begin early in the product life cycle, and overall responsibility for managing the strategy for any product must be assigned to an individual, most logically to a member of the project team. Technical experts need clear guidance and input at the early stages of a project to ensure that the format and technical content of documentation meets the regulatory requirements and are consistent with the rest of the submission. CMC issues can most effectively be managed with the agencies if the regulatory liaison has the technical expertise to discuss the issues with the regulators at a comparable technical level.