The US Food and Drug Administration (FDA) released new guidance on 25 July for industry regarding three quality documents released by the International Conference on Harmonization (ICH) related to how manufacturers and sponsors can best prepare these documents for inspection by regulators in the US, EU and Japan.
The guidance is co-sponsored by FDA's Centers for Drug Evaluation and Research (CDER) and Biologics Evaluation and Research (CBER), both of which are in charge of assessing and implementing ICH's Q8 (Pharmaceutical Development), Q9 (Quality Risk Management) and Q10 (Pharmaceutical Quality System) quality documents. According to ICH, the three documents have been the subject of some confusion, and the harmonizing organization released additional implementation guidance in the form of a question-and-answer document to quell concerns.
FDA's guidance adopts ICH's language from its "Points to Consider" document for the three quality guidelines, which FDA noted is based on several training workshops conducted by ICH between 2009 and 2011.
US regulators also cautioned that the document is not intended to be new guidance in the traditional sense of the word, but rather exists to, "provide clarity to both industry and regulators and to facilitate the preparation, assessment and inspection related to applications filed for marketing authorizations."
The guidance goes on to describe a number of aspects for regulatory professionals to consider, including the relationship between risk and potential harm, conducting risk assessments, linking potential harms to harm-reduction strategies, controlling a product's risk throughout its lifecycle, continuous improvement strategies, scalability of control strategies, real-time release testing and batch release decisions.
Additional guidance is available on the role of models in quality by design, points to consider for design space and processes for validation and continuous process verification.
FDA - Q8, Q9, & Q10 Questions and Answers -- Appendix: Q&As from Training Sessions (Q8, Q9, & Q10 Points to Consider)