Quality systems are here, there’s no doubt about it. The outcome of this week’s ICH expert working group meeting is sure to nail down that fact even harder. Taking place in Portland, Oregon, ICH and industry representatives from around the world are expected to discuss next steps for ICH Q10: Quality Systems, which is intended to augment good manufacturing practices in the three ICH regions: Europe, Japan, and the United States. Q10, currently in Step 3 of the ICH harmonization process, which involves working toward regional consensus, is likely to move to Step 4, or regional endorsement. Once in Step 4, an ICH guideline moves immediately to the final stage, Step 5, or regulatory implementation.

Also on the table at this week’s expert working group meeting is ICH Q11: Development and Manufacture of Drug Substances. The ICH steering committee endorsed a final concept paper and a business plan on Q11 in April. The proposed Q11 guidance is focused on harmonizing the technical principles relevant to the design, development, and manufacture of drug substances as part of a total control strategy designed to ensure product quality and consistency. The guidance, in general, is for APIs, including both chemical and biological entities, and is meant to further clarify guidance for those substances defined in ICH Q6A and Q6B. ICH Q11 is expected to move to Step 2 of harmonization by the end of 2009 and to Step 4 by the end of 2010.

If reached, Q11 will “fill a gap in the regulatory framework,” according to the business plan, and describe in more detail what’s expected in the ICH M4 common technical document regarding the drug substance manufacturing process and process controls, material control, critical step and intermediate control, process validation, and process development.  Q11 is also expected to help save costs in four major areas: assessor time spent searching, requesting, and reassessing information; scientific writing of initial documentation for marketing authorization applications; preparation and reviewing queries for regional documentation requirements; and updating regional documentation.

Pharmaceutical Technology and SGS are hosting a webcast June 12 at 11 am EDT to discuss the results of the expert working group meeting. Some of the panelists in the webcast are participating in the expert group discussions. Sign up for the webcast and be one of the first to hear the latest on Q10 and Q11 here .