FDA issues final guidance on ICH Q10

By building upon good manufacturing practices (GMP) the International Conference on Harmonization's (ICH) Q10 attempts to provide a comprehensive model for an effective quality management system.

The implementation of aspects of ICH Q10 not covered by GMP is optional. However, by adopting the additional processes outlined in the US Food and Drug Administration’s (FDA) guidance manufacturers should benefit from the innovation and continual improvement that are central tenets of ICH Q10.

In addition unlike GMP ICH Q10 explicitly covers all aspects of a product’s lifecycle, from development through to discontinuation, and is designed to strengthen the link between pre- and post-commercialisation manufacturing activities.

Within this framework the FDA identifies three main objectives: achieve product realisation, establish and maintain a state of control and facilitate continual improvement.

To achieve these goals the FDA recommends companies use knowledge and quality risk management, with the guidance detailing how these ICH Q10 “enablers​” should be used.

Senior management has the ultimate responsibility to execute these tasks, according to the guidance that provides a list of seven tasks that people in these roles should perform, including:

“Define individual and collective roles, responsibilities, authorities, and inter­relationships of all organizational units related to the pharmaceutical quality system​.”

Those in charge of implementing the guidance should also apply it to their outsourced activities and the purchase of raw materials. This includes conducting assessments of suppliers and service providers before entering into an agreement.

The complete guidance can be found here​.