Annex to ICH Q8 Pharmaceutical Development Finalized
The Annex to ICH Q8 Pharmaceutical Development was finalized (reached Step 4 of the ICH process) at the International Conference on Harmonisation (ICH) Steering Committee meeting in Brussels, 8 – 13 November 2008. At Step 4 of the ICH process, the final draft is recommended for adoption by the regulatory bodies of the European Union, Japan, and the US.
The annex provides further clarification of key concepts outlined in the core guideline. In addition, this annex describes the principles of quality by design (QbD). The annex is not intended to establish new standards: however, it shows how concepts and tools (e.g., design space) outlined in the parent Q8 document could be put into practice by the applicant for all dosage forms. Where a company chooses to apply quality by design and quality risk management (Q9: Quality Risk Management), linked to an appropriate pharmaceutical quality system, then opportunities arise to enhance science- and risk-based regulatory approaches (see Q10: Pharmaceutical Quality System). The annex was incorporated into the core guideline in November 2008.
It is envisaged that greater understanding of pharmaceutical and manufacturing sciences will create a basis for more flexible regulatory approaches. The Quality Implementation Working Group that was established at the Portland meeting, will be developing a Q&A document to answer questions arising from the new Q8, Q9, and Q10 guidelines. These quality guidelines promote a more conceptual and flexible approach to pharmaceutical quality.