ICH Q11 Process Validation Discussion Will Be at High Level Given Guideline’s Scope

The ICH Q11 Expert Working Group (EWG) is settling on a high level approach to addressing process validation in its drug substance development and manufacturing guideline, reflecting the challenges of encompassing drug and biotech products and the evolving expectations across the three regions.

At the CASSS/FDA Well Characterized Biotechnology Pharmaceutical (WCBP) conference in Washington, D.C. in mid-January, Q11 Rapporteur Brian Withers (Abbott UK) explained the challenges with which the EWG has wrestled in putting together a validation discussion in the guideline and where the group has arrived in its effort to address them.

Withers substituted for fellow EWG member Brendan Hughes (Pfizer, US), who had developed the validation presentation and was unable to attend. Withers also gave a more general update on the EWG Q11 progress at the session that he had prepared (IPQ “In the News” Jan. 24).

He prefaced his remarks by emphasizing that Q11 still is a work in progress and that the current draft will go through further revision.

An immediate challenge for the EWG in addressing process validation in Q11 is that the guideline’s scope is drug substance, while validation encompasses the drug product as well.  “So immediately we have got to be careful about creating guidance that could be applicable to drug product and giving indications there, where our scope was only drug substance,” Withers said.

The guideline’s coverage of both small and large molecules was also a constraint due to the different timing and filing requirements involved.

While validation information does have to be filed for biotech products, small molecules generally do not require validation at filing unless they are sterilized. In this context, the question was raised why a validation section was needed in Q11, since Q7 provides relevant GMP guidance, Withers said.  However, he noted, it was a “very clear” in the concept paper that validation should be addressed in the guideline.

Getting the balance right between the traditional and enhanced/continuous process verification (CPV) approaches further contributed to the difficulty in handling the validation discussion.

[Wither’s update on how the EWG is resolving the challenges in addressing process validation in the Q11 context is provided for subscribers here.  Non-subscribers can purchase the full story for $95 by contacting Jonathan Trethowan (Jonathan@ipq.org).  For subscription information click here.]