Practical Implementation of the ICHQ10 Concepts Working Group

ICH Q10 describes one comprehensive approach to an effective pharmaceutical quality system and is a model that can be implemented throughout the different stages of a product lifecycle.  ICH Q10 provides for a number of key requirements, components and enablers of a modern quality system. However like most ICH documents it is written from a high level conceptual standpoint. It is left to the individual companies to translate these concepts into their organization. Therefore the proposed problem statement: There is no guidance document that describes the practical implementation of the ICHQ10 principles. How does an organization build and sustain a modern, efficient, highly complaint, Q10 focused QA organization?

The ICHQ10 Working Group plans to develop a guidance document that outlines the steps needed to translate the ICHQ10 principles to reality within a pharmaceutical organization. This will be done by developing a benchmarking survey to understand how various companies organize their quality organizations to align with ICHQ10 requirements and to meet individual business needs. Through development and analysis of this survey, the WG hopes to understand common themes related to developing a Pharmaceutical QA quality system. In addition, the working group will evaluate currently available public literature and the expertise of the companies part of this working group and the broader GMP QA Leadership group. This information will be collated to build the eventual practical guidance paper.