The interpretation and application of the approaches for determining established conditions (ECs) provided in the Step 2 draft of ICH Q12 and how these interface with regulatory reporting expectations is drawing particular attention as industry explores the opportunities that the ICH Q12 concepts present in practice.
The concept of established conditions is viewed as a key pillar in the Q12 effort to address the current global regulatory labyrinth that industry faces in pursuing manufacturing and analytical improvements and to create a more flexible, risk-based and harmonized lifecycle paradigm.
Drawing close consideration at public forums are the benefits provided in the guideline for moving down the pathway from a parameter to a performance-based approach for determining the established conditions. The enhanced process understanding supporting the performance-based approach allows the focus to shift from inputs onto critical outputs, reducing the number of ECs, and in turn, post-approvals changes needing to be filed.
ICH Q12 Expert Working Group (EWG) members at these venues are encouraging industry to share its insights on and experience with implementing the established conditions concepts in the draft guideline – and the performance-based approach, in particular – to help make the guideline as effective as possible as it emerges in final form and a training program is rolled out globally.
Among the industry/regulator venues shedding light on the EC implementation process and potential benefits was a half-day session at the IFPAC conference held in Bethesda, Maryland in February at which nine different speakers offered valuable insights.
The participants explored what a performance-based approach looks like and the flexibility it can provide in different contexts such as continuous drug substance, small molecule drug product, and monoclonal antibody (Mab) manufacturing, and in the analytical procedure and process analytical technology (PAT) contexts.
With its practical implementation focus, the IFPAC session complemented the dialogue at a Q12 session of the 2018 CASSS WCBP conference held a few weeks earlier (see IPQ July 3, 2018).
The WCBP session provided a dozen of the key players involved in the guideline’s development, including nine EWG members, the opportunity to share insights on its intent and significance and the issues that are most pressing in making sure that its transformational goals are achieved. Effective use of the EC concepts – the primary focus at the IFPAC session – was highlighted by the EWG participants during the WCBP discussions as key in the guideline’s successful implementation and among the areas where feedback on the draft would be most helpful.