ICH Moves to Estonia in June: Heavy Metals, APIs, Implementing Q8-10 in Focus

ICH is gathering in Tallinn, Estonia in early June to focus on advancing its quality guidance harmonization initiatives on heavy metals (Q3D), drug substances (Q11), pharmacopeial methods (Q4B), and ICH Q8-10 implementation.

At its Fall 2009 meeting in St. Louis, ICH agreed to extend its Q3A guideline series on impurities to address heavy metals under the moniker “Q3D.”  Reflecting the concerns of the regulatory community regarding heavy metals and the desirability of a harmonized approach to the criteria and methodologies needed to control them (IPQ, Nov./Dec. 2008, pp. 37-39), the ICH Steering Committee endorsed the proposed plan and the setting up of a Q3D working group in St. Louis.

Another current thrust of ICH in the quality arena that will get expert working group (EWG) attention in Estonia is the development of a guideline to accompany the ICH Q8-10 series focused specifically on drug substances.

The objective of the “Q11” guideline is defined as harmonizing the scientific and technical principles relating to the description and justification of the API design, development and manufacturing process. Q11 will address the concepts embedded in ICH Q8(R) – for example, related to development, the use of quality risk management, quality by design and design space – as they apply in the drug substance context.  The EWG hopes to clear a “Step 2” document for public comment in Tallinn.

To facilitate consistent ICH Q8-10 implementation, the ICH implementation working group (IWG) is pursuing a three-pronged approach: developing Q&A documents; developing case studies; and holding training workshops in the three regions.

The first in a series of three workshops will be held June 2-4 in Tallinn in conjunction with the ICH meeting (beginning June 5).  A workshop will follow in October in Washington, D.C., and in Tokyo, Japan in November in conjunction with the scheduled ICH meeting there.  The European and U.S ICH Q8-10 trainings are being cosponsored by ISPE and PDA.

The workshops, including regulators and industry, will cover the integrated implementation of Q8-10 across the product lifecycle, including development, manufacturing, regulatory assessment, scale-up to commercial operation, and GMP inspection.

Q8-10 IWG member Moheb Nasr, who directs CDER’s Office of New Drug Quality Assessment (ONDQA) commented at a recent conference that ICH has been good at the development of harmonized guidelines. “What it has not been as good at,” he suggested, is making sure the implementation of these guidelines within and outside the ICH regions is harmonized – that “once they leave the room where the experts got together to develop these guidelines, everyone had a clear understanding and implemented consistently.”

Nasr views the practical implementation thrust of ICH as “one of the most exciting things that we have worked on in the last few years” in evolving the ICH quality paradigm, “because in my estimate, that is what was missing.”  The goal, he explained, is to present different ways to implement the high level guideline concepts “not only in the development at the bench, but when you implement at full scale,” along with “the views of the regulators and how the regulatory assessment and inspection will take place.”

[EDITOR’S NOTE:  An analysis of the new ICH quality guidance initiatives and their goals is included in the IPQ May special report.]