ICH Q14: April 2023 Virtual Symposium

Labcorp Biopharmaceutical CMC Services has been at the forefront of implementing ICH Q14 guidelines and using risk-based approaches around QbD for CMC services. In ICH Q14, the QbD principles are being applied to analytical development, incorporating a predefined Analytical Target Profile (ATP), risk assessment to identify the critical method parameters and design of experiment (DoE) testing to give a Proven Acceptable Range (PAR) or Method Operable Design Range (MODR). One aspect of ICH Q14 is the concept of lifecycle management, comprising a control strategy and performance monitoring to ensure that the method remains in a continual state of control, yet allowing for continual improvement. Given the imminent release of ICH Q14 and its expected impact on analytical method development approaches, Labcorp Biopharmaceutical CMC Services sponsored a virtual symposia on ICH Q14 in April 2023 which featured two industry experts to discuss their interpretations and implications of ICH Q14. This is a recording of that event.