ICH Q11, the anticipated guideline from the International Conference on Harmonization (ICH), titled Development and Manufacture of Drug Substances, has achieved international consensus. Q11 has been one of the fastest guidelines to move through the ICH harmonization process. Q11 was published as a draft in May 2011, and reached Step 4 this month, which means that the ICH steering committee members (representing regulatory and trade organizations in the US, Europe, and Japan), have reached scientific consensus and signed the guideline. At this point, each of the region’s regulatory agencies, including FDA, will publish the guideline as official guidance within their appropriate regions and implementation will begin.

The Q11 guideline will be folded into the Quality trio which includes ICH Q8 Pharmaceutical Development, Q9 Quality Risk Management, and Q10 Pharmaceutical Quality System, which together detail quality-by-design (QbD) concepts for pharmaceutical development and manufacturing. Although the ICH Quality trio guidelines apply to drug substance as well as drug product, industry and regulators felt there was a need to clarify QbD or "enhanced" concepts for drug-substance manufacture.

"There are fundamental scientific differences in the process for drug-substance manufacture and the process for drug-product manufacture, including impurity control and removal and chemical transformations," explained Pharmaceutical Research and Manufacturers Association (PhRMA) representatives of the ICH Q11 expert working group to PharmTech. These representatives, among others, talked to PharmTech earlier this year regarding the expected approval of Q11; their discussion of the guideline can be found in the February 2012 issue cover story.

Q11 describes approaches to developing process and drug substance understanding and also provides recommendations to industry on what information should be provided in Common Technical Document sections 3.2.S.2.2–3.2.S.2.6. The guideline provides further clarification on the principles and concepts described in ICH Q8, Q9, and Q10 as well.

Read the full ICH Q11 guideline.