ICH Q11 Guideline Structure and Content Taking Shape

The structure and content of ICH Q11 on drug substance development and manufacturing is taking shape as the Expert Working Group (EWG) resolves the challenging issues around the guideline’s breadth and depth and its relationship to the other guidelines in the ICH quality family.

Under the current structure emerging out of the EWG discussions at its June meeting in Tallinn, Estonia, the guideline will contain sections on: ● manufacturing process development ● description of the manufacturing process ● starting materials ● control strategy ● process validation/evaluation ● process lifecycle management, and ● location of information in the CTD.

Each of the sections includes discussion of the applicable principles, identification of molecule-specific information (small vs. large, etc.) that may be needed, and what information should be provided to the regulator in filings relevant to the section topic.

At DIA’s annual meeting in Washington, D.C. in mid-June, ICH Q11 rapporteur Brian Withers (Abbott U.K.) provided an update on the discussions at the Tallinn EWG meeting the week before and the current status of the guideline’s structure and content.

Withers stressed the general importance of Q11 “both from making some of the principles in Q8 real for biotech” and in extending them from development into manufacturing.

Q11 is intended to be a high-level guidance clarifying and harmonizing the regulatory expectations relevant to manufacture as well as design and development. “That is important,” Withers commented, “because Q8 did not get into the manufacturing” of the drug product, whereas with Q11, “we are moving into that area.  And that has its own set of issues.”

The scope of Q11 stretches across small and large molecule drug substances as defined in Q6A and Q6B, which has involved the EWG in identifying the similarities and differences and how they should be addressed from a guidance point of view, the rapporteur explained.

In developing a structure for the guideline, the EWG decided that Q11 would reach beyond “just telling people what to submit” under the M4Q/CTD format to addressing “enhanced and systematic approaches” and science-based concepts for process development, manufacturing and validation.

[Wither’s update on the content of the specific Q11 sections is provided for subscribers here. See IPQ’s “In the News” companion story for the EWG’s consideration of starting materials and where Q11 is heading on this particular issue].