ICH hits milestone: Q11 draft posted for comments

Those who have come to believe that "Johnson & Johnson" and "quality" are mutually exclusive terms may be surprised to learn that the healthcare giant's director for quality and compliance presented an update on the International Conference on Harmonization's Q11 guideline at DIA's 47th annual conference in Chicago this week.

Betsy Fritschel provided a status report on the effort. The Q11 expert working group has posted a draft document for public comment. The group hopes to receive and resolve comments and then implement the guidance by early 2012.

Determining the document title--ICH guideline Q11 on development and manufacture of drug substances (chemical entities and biotechnological/biological entities)--was "the biggest challenge that we took on with Q11," says Fritschel, according to Pharma QbD. The challenge was ensuring that it covered the entirety of drug substance development and manufacturing for both large and small molecules.

Q11 is necessary to clarify concepts in ICH guidelines on pharmaceutical development (Q8), quality risk management (Q9) and pharma quality systems (Q10) as they relate to drug substance, according to the article. The earlier documents cover drug products. The processes used are different but of course related. "We spend a lot of time on purification," Fritschel says in the story.

This Q11 guideline describes approaches to developing process and drug substance understanding. It also offers guidance on information that should be included in related common technical documents.

- here's the story
- see the draft guidelines (.pdf)