Regulatory Import of Non-critical Parameters Among Issues Under Debate at ICH Q8-10 Workshop

The expectations for non-critical parameters in communicating with regulators on process design, control and change management drew significant attention at the ICH Quality Implementation Working Group (IWG) training workshop in Tallinn, Estonia in early June.

At the workshop, co-sponsored by PDA and ISPE, a large group of regulators from the ICH regions and beyond sat down with industry to explore where the gaps are in the existing Q8-10 guidance based on their expanding implementation experience.

In breakout sessions through which the attendees rotated focused on design space, control strategy, risk management and quality systems, the IWG asked for input on three basic questions: ● Are the guidelines clear on the key messages? ● What practical concerns are emerging with implementation? and ● Where is more clarification needed to assure a harmonized approach?

The implication for regulatory filings and inspections of decisions on the criticality of parameters – an area that drew attention during the Q8-10 development process – continues to be of concern.

Workshop participants pointed to a lack of clarity around the expectation for including information on non-critical parameters in describing the process and design space in applications, and in turn, the corresponding regulatory implications for change management.

Joining a panel of IWG members at the conclusion of the workshop, FDA Center for Drug Evaluation and Research (CDER) Office of New Drug Quality Assessment (ONDQA) Director Moheb Nasr was prompted to comment on the concerns raised around parameter criticality and the implications for those judged non-critical.

[More on the criticality discussions and their relationship to the broader issues of how much information needs to be included in filings and the implications on the review and inspection processes is provided for subscribers here.]