Overview of the January 2020 CASSS Sharing Science Solutions Workshop on Established Conditions

The ICH Q12 Guideline on Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management and its Annexes reached Step 4 of the ICH Process at the ICH meeting in Singapore on 21 November 2019. This new Guideline provides a framework to facilitate the management of post-approval Chemistry, Manufacturing and Controls (CMC) changes in a more predictable and efficient manner across the product lifecycle. One essential concept of ICH Q12 is that sponsor propose, and regulators agree to Established Conditions (EC’s) for manufacturing processes. ECs are legally binding information considered necessary to assure product quality. ICH Q12 on January 27th, 2020 CASSS sponsored a Sharing Science Solutions workshop on the identification of Established Conditions in support of ICH Q12 implementation. Run in parallel with the CASSS CMC Strategy Forum North America meeting in Washington DC, this workshop invited industry participants and FDA to share ideas and progress toward the implementation of ICH Q12 with a focus on the identification EC’s and their proposed reporting categories. Over 50 attendees participated in the workshop, representing over 20 companies (large and small), FDA (CBER, CDER), and PEI. Three industry case studies were presented, followed by a panel discussion and a working session where workshop participants identified EC’s for a cation-exchange chromatography case study using Traditional/Minimal, Enhanced, and Performance-based approaches. This talk will provide a summary of that workshop.